Bladder Health COE Articles

Articles

  • Is Overactive Bladder in the Female Surgically Curable by Ligament Repair?

    Introduction
    The existing framework for the management of over-active bladder symptoms (OAB) (urge, frequency, nocturia) is essentially what has been defined and recommended by the ICS (International Continence Society)1. OAB symptoms in women are said to be associated with chronic pelvic pain (CPP), bowel dysfunction and organ prolapse, but no numerical relationship has been stated 1. The pathogenesis of OAB is not stated by ICS. However, the 5th International Consultation 2 states that “OAB (symptomatic diagnosis) is often assumed to be caused by detrusor overactivity (DO; urodynamic diagnosis), even if this does not always seem to be the case”. Regarding the treatment of OAB, the Consultation states, “Many drugs have been tried, but the results are often disappointing, partly due to poor treatment efficacy and/or side effects” 2. No surgical treatment for OAB is mentioned in the Incontinence 5th International Consultation Paris Feb 2012.
    Published November 13, 2018
  • Association of Pharmacologic Treatment of Urgency Urinary Incontinence With Sleep Quality and Daytime Sleepiness.

    To evaluate the association between pharmacologic therapy for urgency urinary incontinence (UUI) and sleep quality.

    We conducted a planned secondary data analysis of sleep outcomes in a previously conducted multicenter, double-blind, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence among community-dwelling women self-diagnosed using the 3-Incontinence Questions questionnaire.

    Published January 15, 2018
  • Best Practices for Management - Indwelling Urinary Catheters

    • Document in the patient’s medical record all procedures involving the catheter or drainage system.
    • Also practice hand hygiene prior to performing catheter care.
    • Remove catheter as soon as possible to reduce the risk of CAUTIs. Insert the catheter using an aseptic technique.
    • Use the smallest size catheter possible.
    • Cleanse the catheter insertion site daily with soap and water or with a perineal cleanser.
    • Use of an antiseptic or meatal care is unnecessary, use soap and water.
    • Avoid routine or arbitrary catheter changing schedules in the absence of infection.
    • Maintain a uniform and adequate daily fluid intake to continuously flush the urinary drainage system.
    • Clamping the catheter prior to removal is unnecessary.
    • Routine catheter and bladder irrigations and/or instillations are not recommended.
    • Avoid routine urine cultures in the absence of infection.
    • Avoid inappropriate use of antibiotics and antimicrobials.
    • Maintain the acidification of urine.
    • Patients and caregivers should be educated about their role in preventing CAUTIs.
    • Acute and long-term care staff should be educated through quality improvement programs about the selection, insertion, and management of indwelling catheters to reduce UTI incidence.
    • Patients with indwelling urinary catheters should be reevaluated periodically to determine whether an alternative method of bladder drainage can be used instead.
    • Patients should undergo bladder training after catheter removal to successfully regain bladder function.
    • Health-care workers and clinicians in institutions should observe their facility’s protocols for care of catheters and drainage bags. Daily catheter care should include:
      • Labeling on bag insertion date, time and place (e.g. OR, ER).
      • Maintain a closed urinary drainage system to prevent introduction of bacteria into the urinary tract.
      • Adequately secure and anchor the catheter to prevent urethral and bladder-neck tension.
      • Ensure that urine drainage is unobstructed and continuous by avoiding dependent loops, ensuring no kinks in tubing and bag is positioned below the bladder but not on the floor.
      • Scan the bladder if no urine is draining to determine if system is obstructed.
      • Use needleless sampling port for urine specimen collection
      • Anchor and secure catheter
      • Empty bag if > 400 mls to prevent tension on catheter and to prevent the migration of bacteria ascending from bag to catheter.
    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: Document in the patient’s medical record all procedures involving the catheter or drainage system. Also, practice hand hygiene prior to performing catheter care. Remove the catheter as soon as possible to reduce the risk of CAUTIs. Insert the catheter using an aseptic technique
    Published January 15, 2013
  • Best Practices for Management - Intermittent Catheters

    Intermittent catheterization can have a significant physical and/or emotional impact on patients’ lives.

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published February 1, 2013
  • Bundle (ABCDE) Checklist for Prevention of CAUTIs

    Adherence to infection control principles, standard supplies, procedures and processes

    • Hand hygiene - the most important factor in preventing nosocomial infections
    • Aseptic catheter insertion procedure
    • Proper Foley catheter maintenance, education, and care by nursing staff
    • Foley catheter use surveillance and feedback
    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published April 5, 2020
  • Complications - Indwelling Catheters

    Overview  |  Bacteriuria  |  CAUTIs  |  Catheter-Associated Biofilms
    Encrustations  |  Urosepsis  |  Urethral Damage  |  Common Urethral Complications  |  References

    Catheter-Associated Complications

    Catheter related problems due to an indwelling urinary catheter (IUC) have existed as long as urinary catheters have been utilized.  This section will review IUC complications: infectious complications such as (symptomatic bacterial infection, cystitis, pyelonephritis, urosepsis, and epididymitis), catheter blockage (due to calculi, biofilms, and encrustations), catheter related malignancy, hematuria, stones, urethral stricture and fistula from urethral injury, traumatic hypospadias, and periurethral urine leakage. 

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published January 15, 2013
  • Complications - Intermittent Catheters

    Urethral Adverse Events  |  Scrotal Complications  |  Bladder-related Complications  |  Pain  | Urinary Tract Infections  |  Causes of IC-related UTIs  |  Video Lecture  |  References

    Intermittent catheterization (IC) is the preferred procedure for people with incomplete bladder emptying not satisfactorily managed by other methods. Complications and adverse events can arise in both men and women but are seen especially in male patients performing intermittent self-catheterization long-term.

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: Intermittent catheterization (IC) is the preferred procedure for people with incomplete bladder emptying not satisfactorily managed by other methods. Complications and adverse events can arise in both men and women but are seen especially in male patients performing intermittent self-catheterization long-term. Urethral/scrotal events can include bleeding, urethritis, stricture, the creation of a false passage, and epididymitis. Bladder-related events can cause UTIs, bleeding, and stones. The most frequent complication of IC is urinary tract infection (UTI).
    Published March 4, 2020
  • Complications & Adverse Events – External Urinary Catheters

    An external urine collection device (EUCD) may be external and less invasive but they are not free of risks. Complications and adverse effects include skin lesion/ulceration and breakdown from pressure necrosis and moisture, urethral fistula or very rarely, gangrene of the penis. The majority of complications involve perineal/genital skin issues, primarily occurring in 15-30% of male patients and involve external penile shaft problems. EUCD complications in male patients with spinal cord injuries causing paralysis and neurogenic lower urinary tract dysfunction (NLUTD) should be extremely vigilant with regard to penile skincare as minor skin adverse events can lead to anatomical destruction (e.g. penile shaft erosion, gangrene and partial amputation of the penis).

    Skin irritation, lesions, rashes and infections

    Skin adverse effects are commonly seen and include dermatitis, erosion, and maceration. In men, the skin on the penile shaft is most often affected and in women, the labial and vulvar areas are affected. Causes include a “too tight device” which can increase pressure and occlusion of the penile shaft or pubic area. An excessive or uneven adhesive from a self-adhesive product can cause skin irritation. Some advocate using a liquid polymer acrylate (liquid skin barrier) to protect the underlying skin which promotes adherence.

    Allergic reactions primarily from latex-based devices have been reported, but EUCD material has moved to more skin-friendly material (e.g., silicone).   Milanesi et al. 2013 noted epidermal sloughing of the entire penile shaft in a male patient with long-term use of an external catheter, possibly caused by sensitization to thiurams in latex. Urine can get trapped between the catheter and skin, especially in an ill-fitted device, leading to skin breakdown.  Bycroft et al (2003) reported on a 39-year-old male who presented to the emergency department with an erosion of the penile skin, maceration, and irritation caused by friction from a self-adhesive external catheter. If skin breakdown occurs on the penile shaft, consider changing to a reusable EUCD or glans-adherent male external catheter (MEC).

    Catheter-associated Urinary Tract Infections

    There is a lack of microbiology studies of urine cultures associated with external catheters in comparison to urine cultures from indwelling catheters. Although the use of EUCDs is increasing in the care settings (e.g. acute care), they are not included in standard medical device surveillance. So little is known about the typical microbiology profile associated with their use.

    Saint and colleagues (2006) demonstrated an 80% reduction in UTIs with men using an external catheter when compared with those men using an indwelling urethral catheter (IUC), despite the fact that MEC-associated bacteriuria may represent contamination. Grigoryan and colleagues (2014) conducted a cross-sectional study in five medicine and five extended-care wards of a VA tertiary care facility of all patients (n=308) who had both a urinary catheter (external or indwelling) and positive urine culture during a nine-month period. Five hundred and ninety-three organisms were identified and the mean number of organisms per culture was significantly higher in patients with external catheters compared with those with indwelling catheters. The prevalence of all gram-positive organisms combined was somewhat higher in urine cultures from external catheters than indwelling catheters, but individual gram-positive organisms (Staphylococci, Enterococci, Corynebacterium, and Lactobacillus) did not differ significantly. The prevalence of all gram-negative organisms and Enterobacteriaceae were also similar between groups. But Candida and gram-negative non-Enterobacteriaceae (mostly Pseudomonas), both more apt to cause the formation of biofilms) were significantly more common in urine cultures from indwelling catheters than external catheters.

    table 1 complications external urinary catheters2x

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN, Adjunct Professor of Urology in Surgery, Research Investigator Senior, Perelman School of Medicine, Co-Director, Penn Center for Continence and Pelvic Health, Division of Urology, University of Pennsylvania, Philadelphia, Pennsylvania

    Published Date: April 17th, 2020

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: 1. Al-Awadhi, N. M., N. Al-Brahim, M. S. Ahmad, and E. Yordanov. "Giant fibroepithelial polyp of the penis associated with long-term use of condom catheter. Case report and literature review." The Canadian journal of urology 14, no. 4 (2007): 3656-3659.
    2. Banerji, John S., Sanjeev Shah, and Nitin S. Kekre. "Fibroepithelial polyp of the prepuce: A rare complication of long-term condom catheter usage." Indian journal of urology: IJU: journal of the Urological Society of India 24, no. 2 (2008): 263.
    3. Beeson, Terrie, and Carmen Davis. "Urinary management with an external female collection device." Journal of Wound, Ostomy, and Continence Nursing 45, no. 2 (2018): 187.
    4. Bycroft, J., R. Hamid, and P. J. R. Shah. "Penile erosion in spinal cord injury–an important lesson." Spinal cord 41, no. 11 (2003): 643-644.
    5. Golji, Hossein. "Complications of external condom drainage." Paraplegia 19, no. 3 (1981): 189-197.
    6. Grigoryan, Larissa, Michael S. Abers, Quratulain F. Kizilbash, Nancy J. Petersen, and Barbara W. Trautner. "A comparison of the microbiologic profile of indwelling versus external urinary catheters." American journal of infection control 42, no. 6 (2014): 682-684.
    7. Harmon, Christopher B., Suzanne M. Connolly, and Thayne R. Larson. "Condom-related allergic contact dermatitis." The Journal of urology 153, no. 4 (1995): 1227-1228.
    8. Newman, D. K. "Devices, products, catheters, and catheter-associated urinary tract infections." Core curriculum for urologic nursing. 1st ed. Pitman: Society of Urologic Nurses and Associates, Inc (2017): 439-66.
    9. Newman, Diane K., and Alan J. Wein. "External Catheter Collection Systems." In Clinical Application of Urologic Catheters, Devices and Products, pp. 79-103. Springer, Cham, 2018.
    10. Milanesi, Nicola, Gastone Bianchini, Angelo Massimiliano D'ERME, and Stefano Francalanci. "Allergic reaction to condom catheter for bladder incontinence." Contact dermatitis 69, no. 3 (2013): 182-183.
    Published April 17, 2020
  • Definition - Intermittent Catheters

    What is an intermittent urinary catheter?

    Intermittent catheterization (IC) is the insertion and removal of a catheter several times a day to empty the bladder. The purpose of catheterization is to drain urine from a bladder that is not emptying adequately or from a surgically created channel that connects the bladder with the abdominal surface (such as Mitrofanoff continent urinary diversion).

    catheter

    Intermittent catheterization is widely advocated as an effective bladder management strategy for patients with incomplete bladder emptying due to idiopathic or neurogenic detrusor (bladder) dysfunction (NDO).

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: Intermittent catheterization (IC) is the insertion and removal of a catheter several times a day to empty the bladder. This type of catheterization is used to drain urine from a bladder that is not emptying adequately or from a surgically created channel that connects the bladder with the abdominal surface (such as Mitrofanoff continent urinary diversion). Intermittent catheterization is widely advocated as an effective bladder management strategy for patients with incomplete bladder emptying due to idiopathic or neurogenic detrusor (bladder) dysfunction (NDO).
    Published November 29, 2019
  • Definition – External Urine Collection Device

    An external urine collection device (EUCD) is defined as a catheter or product that attaches to the perineum. These collection systems drain urine via tubing attached to a bag or via tubing that suctions urine to a container. EUCDs are primarily used in men or women with urinary incontinence. They are either one-time disposable devices or reused multiple times and are made from many materials but the most common material is latex and silicone.
    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: 1. Beeson, Terrie, and Carmen Davis. "Urinary management with an external female collection device." Journal of Wound, Ostomy, and Continence Nursing 45, no. 2 (2018): 187.
    2. Deng, Donna Y. "Urologic Devices." In Clinical Application of Urologic Catheters, Devices and Products, pp. 173-220. Springer, Cham, 2018.
    3. Eckert, Lorena, Lisa Mattia, Shilla Patel, Rowena Okumura, Priscilla Reynolds, and Ingrid Stuiver. "Reducing the Risk of Indwelling Catheter–Associated Urinary Tract Infection in Female Patients by Implementing an Alternative Female External Urinary Collection Device: A Quality Improvement Project." Journal of Wound Ostomy & Continence Nursing 47, no. 1 (2020): 50-53.
    4. Newman, Diane K., and Alan J. Wein. "External Catheter Collection Systems." In Clinical Application of Urologic Catheters, Devices and Products, pp. 79-103. Springer, Cham, 2018.
    5.Newman, D. K. "Devices, products, catheters, and catheter-associated urinary tract infections." Core curriculum for urologic nursing. 1st ed. Pitman: Society of Urologic Nurses and Associates, Inc (2017): 439-66.
    6. Fader, Mandy, Donna Bliss, Alan Cottenden, Katherine Moore, and Christine Norton. "Continence products: research priorities to improve the lives of people with urinary and/or fecal leakage." Neurourology and Urodynamics: Official Journal of the International Continence Society 29, no. 4 (2010): 640-644.
    7. Geng, V., H. Cobussen-Boekhorst, H. Lurvink, I. Pearce, and S. Vahr. "Evidence-based guidelines for best practice in urological health care: male external catheters in adults urinary catheter management." Arnhem: European Association of Urology Nurses (2016).
    8. Gray, Mikel, Claudia Skinner, and Wendy Kaler. "External collection devices as an alternative to the indwelling urinary catheter: evidence-based review and expert clinical panel deliberations." Journal of Wound, Ostomy, and Continence Nursing 43, no. 3 (2016): 301.
    9. Lachance, Chantelle C., and Aleksandra Grobelna. "Management of Patients with Long-Term Indwelling Urinary Catheters: A Review of Guidelines." (2019).
    10. Newman, D. K. "Devices, products, catheters, and catheter-associated urinary tract infections." Core curriculum for urologic nursing. 1st ed. Pitman: Society of Urologic Nurses and Associates, Inc (2017): 439-66.
    11. Newman, Diane K., and Alan J. Wein. "External Catheter Collection Systems." In Clinical Application of Urologic Catheters, Devices and Products, pp. 79-103. Springer, Cham, 2018.
    Published April 17, 2020
  • Designs - Indwelling Urinary Catheters

    Bard timeline

    Catheters are semi-rigid but flexible tubes. They drain the bladder but block the urethra.

    The challenge is to produce a catheter that matches as closely as possible to the normal physiological and mechanical characteristics of the voiding system.catheter_tips.png

    This requires construction of a thin-walled, continuously lubricated, collapsible (conformable) catheter to protect the integrity of the urethra; a system to hold the catheter in place without a balloon; and a design to imitate the intermittent washing of the bladder with urine.

    Catheter products have changed significantly in their composition, texture, and durability since the 1990s.

    The catheter should have a smooth surface with two drainage eyes at the tip that allow for urine drainage.

    Drainage eyes are placed either laterally or opposed. Opposing drainage eyes generally facilitate better drainage.

    Catheter Tips

    The most commonly used catheter is a straight-tipped catheter.

    A Coudé-tipped catheter, or Tiemann catheter, is angled upward at the tip to assist in negotiating the upward bend in the male urethra.  

    This feature facilitates passage through the bladder neck in the presence of obstruction from a slightly enlarged prostate gland (e.g., in benign prostatic hyperplasia) or through a narrowed stricture in the urethra.catheter_angle.png

    The Carson catheter is a slightly larger bulb to assist in negation of restrictions. 

    The Council catheter features a reinforced hole at the tip of the catheter.

    A whistle-tipped catheter is open at the end and allows drainage of large amounts of debris (e.g., blood clots).

    Catheter Size and Length 

    Each catheter is sized by the outer circumference and according to a metric scale known as the French (Fr) gauge (range is 6 to 18 Fr), in which each French unit equals 0.33 mm in diameter.catheter_size.png

    The golden rule is to use the smallest catheter size (termed bore), generally 14 to 16 Fr, that allows for adequate drainage.

    The use of large-size catheters (e.g., 18 Fr or larger) is not recommended because catheters with larger diameters can cause more erosion of the bladder neck and urethral mucosa, can cause stricture formation, and do not allow adequate drainage of periurethral gland secretions, causing a buildup of secretions that may lead to irritation and infection. Also, large size catheters can cause pain and discomfort.  

    Balloon Size

    A retention balloon prevents the catheter from being expelled. The preferred balloon size may be labeled either 5 mL or 10 mL, and both are instilled with 10 mL of sterileballoon_size.png water for inflation per manufacturer’s instructions. Larger balloons (30 cc – 60 cc) are generally used to facilitate drainage or provide hemostasis when necessary, especially in the postoperative period. The balloon of the catheter usually sits at the base of the bladder, obstructing the internal urethral orifice. 

    A fully inflated balloon allows the catheter tip to be located symmetrically. If a 5 mL balloon is inflated with more than 10 mL of water, irritation may occur unilaterally on the bladder wall from increased pressure of the balloon.

    The specified amount of inflation ensures a symmetrical shape and allows for the catheter to maintain position in the bladder while minimizing patient discomfort   Underfilling or overfilling may interfere with the correct positioning of the catheter tip, which may lead to irritation and trauma of the bladder wall.

    A balloon with a fill size greater than 10 mL, such as a 30 mL balloon, is not recommended because the 10 mL size keeps residual urine minimal, thus reducing the risk ofproper_inflated_balloon.png infections and irritation.

    The catheterized bladder is in a collapsed state as a result of constant urine drainage. However, a 30 mL balloon will allow persistence of a small pool of undrained urine, so the bladder emptying is not complete and the undrained urine can leak around the catheter (referred to as “catheter bypassing”)..

    The use of a larger balloon size is mistakenly believed by many nurses to be a solution to catheter leakage or urine bypassing around the catheter. However, a large balloon increases the chance of contact between the balloon or catheter tip and the bladder wall, leading to bladder spasms that may cause urine to be forced out around the catheter.

    A 30 mL balloon is used primarily to facilitate traction on the prostate gland to stop bleeding in men after prostate surgery or to stop bleeding in women after pelvic catheterized_bladder.pngsurgery.

    Routine use of larger capacity balloons (30 mL) should be avoided for long-term use as they can lead to bladder neck and urethral erosion.

    Several catheter materials have been found to lose water from the inflated balloon over time in the bladder with 100% silicone catheters losing as much as 50% of their volume within 3 weeks.

    In men, the catheter should be passed initially to the bifurcation (the “Y” junction where the balloon arm and catheter meet) to ensure that the balloon will not be inflated in the urethra. 

    Catheter Materials

    A wide range of catheter materials are available, and the material selected should be chosen by: 

    1. how long the catheter will remain in place,
    2. comfort,
    3. the presence of latex sensitivity,
    4. ease of insertion and removal, and
    5. ability to reduce the likelihood of complications such as urethral and bladder tissue damage, colonization of the catheter system by microorganisms, and encrustation

    Note: Prior to insertion, all indwelling catheters should be visually inspected for any imperfections or surface deterioration.

    1. Latex Catheter: The possibility of a latex allergy is an important consideration as many urinary catheters are constructed from latex or a related material. 

    There are reported increases in allergies and reactions in patients with long-term use of all urinary latex and rubber catheters. Patients who have asthma and other allergies are at increased risk for these allergies. Latex allergy can result in symptoms such as skin irritation, rashes, and blisters. Urethritis and urethral strictures can also result from latex allergies.  Coatings such as silicone and polytetrafluoroethylene (PTFE) are used to coat latex catheters.

    2. Hydrogel coating, which remains intact when used, has demonstrated the ability to reduce the high level of cytotoxicity associated with latex catheters. However, coated latex catheters do not protect against an allergic reaction to the underlying latex because the coating wears off.

    Bonded hydrogel-coated latex catheters may be longer lasting than silicone catheters because their hydrogel coating prevents bacterial adherence and reduces mucosal friction. Hydrogels or polymers coat the catheter, absorbing water to produce a slippery outside surface. This results in the formation of a thin film of water on the contacting surface, thus improving its smoothness and lubricity. These properties might act as potential barriers to bacterial infection and reduce the adhesion of both gram-positive and gram-negative bacteria to catheters. 

    3. Silicone- and hydrogel-coated catheters usually last longer than PTFE-coated catheters. If the person is latex sensitive, silicone catheters should be used. Avoiding silicone_and_hydrogel.pnglatex catheters may also decrease the incidence of encrustation. All-silicone (100%) catheters are biocompatible and are believed to have encrustation-resistant properties.  Silicone catheters are thin-walled, rigid catheters with a larger diameter drainage lumen. 

    4. Antimicrobial-coating: A major problem with Foley catheters is that they have a tendency to contribute to urinary tract infections (UTI). This occurs because bacteria can travel up the catheters to the bladder where the urine can become infected. In an attempt to prevent bacterial colonization, catheters have been coated with silver alloy or nitrofurazone, a nitrofurantoin-like drug.

    This has been helpful, but it has not completely solved this major problem. An additional problem is that Foley catheters tend to become coated over time with a biofilm that can obstruct the drainage. This increases the amount of stagnant urine left in the bladder, which further contributes to the problem of urinary tract infections. When a Foley catheter becomes clogged, it must be flushed or replaced.

    Both nitrofurazone-coated and silver alloy-coated catheters seem to reduce the development of asymptomatic bacteriuria during short-term (< 30 days) use.
    Despite their unit cost, there is a suggestion that these devices might be a cost-effective option if overall numbers of infections are significantly reduced through their use.

    • Antibiotic-coated catheters were found in a meta-analysis to prevent or delay bacteriuria in short-term catheterized, hospitalized patients.  However, in 2012, nitrofurazone impregnated catheters were taken off the market.  
    • Silver is an antiseptic that inhibits growth of gram-positive and gram-negative bacteria. Silver alloy-coated catheters are thought to cause less inflammation and have a bacteriostatic effect because they reduce microbacterial adherence and migration of bacteria to the bladder.
      Because they prevent bacterial adherence, these catheters also minimize biofilm formation through their release of silver ions that prevent bacteria from settling on the surface.  
      There appear to be few adverse effects, and microbial resistance to the active agent is unlikely. 
    Catheter Drainage Bags
    Drainage bags and an anchor for the drainage tube are parts of the design of an indwelling urinary catheter system.  These may include a: leg drainage bag, overnight leg_bag.pngdrainage bag, and a spare leg strap or a device to secure the catheter tubing to the leg.  Drainage bags that cannot be worn and concealed are commonly referred to as “nighttime or overnight bags,” or “large capacity bags,” or “bedside bags”. Drainage bags that can be worn and concealed are commonly referred to as “leg bags” or abdominal bags, commonly referred to as “belly bags.”  Leg bags generally hold 300- 900 cc whereas an overnight bag can hold up to 2000cc.  It is recommended that reusable drainage bag be replaced every 30 days.   

    The current design of urinary drainage bags prevents the introduction of bacteria into the closed indwelling urinary catheter system.  There are anti-reflux bags, single use bags, closed urinary drainage systems, and bags with urine sampling ports.  A leg bag cannot be characterized as closed because of the need to regularly open the leg bag for drainage and connect to an overnight drainage bag in most cases.  To minimize opening of a catheter system, a leg bag can be attached to a larger bag for overnight drainage. 



    References: 
    1. Brosnahan J, A. Jull, et al. Types of urethral catheters for management of short-term voiding problems in hospitalized patients. Cochrane Database of Systematic Reviews, 2004, (1): CD004013.
    2. Gray M. Does the construction material affect outcomes in long-term catheterization? JWOCN, 2006, 33: 116-121.
    3. Lawrence EL. and IG. Turner. Materials for urinary catheters: A review of their history and development in the UK. Med Engineering Phys, 2005, 27: 443-453.
    4. Leuck AM, Johnson JR, Hunt MA, Dhody K, Kazempour K, Ferrieri P, et al. Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: a pilot randomized clinical trial. Am J Infect Control. 2015;43:260-5. DOI: 10.1016/j.ajic.2014.11.021.
    5. Newman D. The indwelling urinary catheter: Principles for best practice. JWOCN, 2007, 24: 655-661.
    6. Pickard R, Lam T, MacLennan G, Starr K, Kilonzo M, McPherson G, et al. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. Lancet. 2012;380:1927-35. DOI: 10.1016/S0140-6736(12)61380-4. 
    7. Politano AD, Campbell KT, Rosenberger LH, Sawyer RG. Use of silver in the prevention and treatment of infections: silver review. Surg Infect (Larchmt). 2013;14:8-20. DOI: 10.1089/sur.2011.097.
    8. Weissbart SJ, Kaschak CB, Newman DK. Urinary drainage bags. In: Newman DK, Rovner ES, Wein AJ, editors. Clinical Application of Urologic Catheters and Products.  Switzerland: Springer International Publishing; 2018, 133-147.
    9. Zugail AS, Pinar U, Irani J. Evaluation of pain and catheter-related bladder discomfort relative to balloon volumes of indwelling urinary catheters: A prospective study.  Investig Clin Urol. 2019 Jan;60(1):35-39. doi: 10.4111/icu.2019.60.1.35. Epub 2018 Dec 6.

    Published Date: January 14th, 2013

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published January 15, 2013
  • First of its Kind: A Core Curriculum for Urologic Nursing

    Published in Everyday Urology - Oncology Insights: Volume 1, Issue 4
    Published Date: December 2016

    The Core Curriculum is a first-of-its-kind textbook that can be used by nurses to study for specialty certification as a urology registered nurse, and is a source of material to support urology nursing instruction in academic programs. It has applicability to nurses in acute care, long term care, home care and rehab settings as all encounter patients with urologic problems.
    Published February 13, 2017
  • ICS 2018: An Overview in Urodynamics Procedures

    Philadelphia, PA (UroToday.com) Mikel Gray, Ph.D., RN provided an overview of urodynamic procedures, which were defined as a set of tests created to estimate storage and evacuation of urine from the lower urinary tract (LUT). These techniques include filling cystometrogram (CMG), uroflowmetry, voiding pressure-flow study, and sphincter EMG.
    Published August 31, 2018
  • ICS 2018: Contemporary Outcomes of Surgery for Bladder Pain Syndrome/Interstital Cystitis

    Philadelphia, PA (UroToday.com) Dr. Chapple from Royal Hallamshire Hospital, Sheffield, and his colleagues presented their experience and outcome of surgical intervention in the management of bladder pain syndrome in a tertiary center.  Management of BPS is multi-modal with a variety of treatments available, however good quality evidence for many is lacking and there is no global consensus for optimum management.
    Published September 2, 2018
  • ICS 2018: Preventing Catheter-Associated UTIs: US Perspective

    Philadelphia, PA (UroToday.com) Shannon Novosad, MD, medical officer at the Centers for Disease Control and Prevention (CDC) has opened Educational Course on Clinical Directions in Continence care by providing an overview of urinary tract infections associated with catheter use in the United States. She provided background information on the current burden of disease in the US, examined guidelines on healthcare-associated urinary tract infections, introduced prevention strategies, and presented future action plans.
    Published August 28, 2018
  • Indication of Catheterization for Intermittent Catheters (IC)

    Intermittent catheterization (IC) can be indicated as a treatment for voiding problems due to disturbances or injuries to the nervous system, non-neurogenic bladder dysfunction, or intravesical obstruction with incomplete bladder emptying.

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published March 4, 2020
  • Indications - Indwelling Catheters

    Use of Indwelling Urinary Catheters  |  Acute Care Catheter Use  |  Indications for indwelling urinary catheter use
    Selected peri-operative needs  |  LTC Catheter Use  |  References

    Each year, urinary catheters are inserted in more than 5 million patients in acute care hospitals and long-term care (LTC) facilities. Historically, indwelling urinary catheters (IUC) have been used in the chronically, medically compromised older adults. 

    The settings in which the prevalence of long-term IUCs usage is the greatest are: 1) skilled nursing facilities, where they are used in residents with UI, and 2) homes where the person requires skilled nursing visits.

    In the home-care setting, the prevalence of IUCs is growing with the increasing number of older adults. The median time of indwelling catheter use in home care is reported as 3 to 4 years.  However, the number of “home-bound” patients who use a catheter indefinitely to manage UI or because of urinary retention has not been well documented in medical or nursing research. 

    Indications for Indwelling Catheter (medical necessity)

    Indwelling catheter overuse occurs when a device is in place without an appropriate indication. There are two ways of reducing IUC use: 1) by minimizing the initial placement of IUCs and 2) by reducing the duration of each catheterization.  Urinary catheters have various medical indications but the most common is short term drainage of the urinary bladder.    For some patients with upper tract deterioration due to elevated bladder storage pressures (e.g. poor compliance from prior radiation therapy, neurogenic disease, etc.), an IUC may have a role.  The catheter permits low pressure, unimpeded drainage of urine from the upper urinary tract through the bladder and then directly into a collection receptacle.  The following are indications for IUC use.

    - Short term for acute urinary retention: 

    •  Sudden and complete inability to void
    •  Need for immediate and rapid bladder decompression
    •  Monitoring of intake and output

    - Temporary relief of bladder outlet obstruction secondary to:

    • Enlarged prostate gland in men
    • Urethral stricture
    • Obstructing pelvic organ prolapse in women

    - Chronic urethral obstruction or urinary retention and surgical interventions, or the use of intermittent catheterization, has failed or is not feasible, or both
    - Short term following a urological or gynecological surgical procedure
    - Irreversible medical conditions are present (e.g., metastatic terminal disease, coma, end stages, of other conditions)
    - Presence of stage III or IV pressure ulcers that are not healing because of continual urine leakage
    - Instances in which a caregiver is not present to provide incontinence care 

     Use of Indwelling Urinary Catheters 

    Although indwelling urinary catheters are commonly used in most clinical settings, data suggest that more than 20% of these catheters are placed without a specific medical indication and that they often remain in place without the knowledge of the patient’s physician. Studies of the appropriateness of use of urinary catheters indicate that 21 to 38% of initial urinary catheterizations are unjustified, and one-third to one-half of days of continued catheterization are unjustified. The current challenges are to develop effective methods to sensitize the minds of clinicians to avoid the routine use of indwelling catheters, remove catheters when they are no longer needed, develop alternative methods for care of urinary incontinence (UI), employ noninvasive methods to measure bladder function and urine output, and improve urine drainage systems.

    Catheter Use in Acute Care Setting (Hospitals, Acute Rehabilitation)

    Catheter_use.png

    In acute care hospital settings, approximately 12-16% of adult patients and up to 25% of all hospitalized patients usually for surgery, urine output measurement, urinary retention, or UI. Their use is greater in high acuity patient units, with critical care and intensive care units having the highest.  At least 8%-23% of patients admitted through the emergency room have an IUC.  Nearly 50% of surgical patients remain catheterized beyond 48 hours postoperatively; approximately 50% of medical patients do not have a clear indication for an IUC.   

    Hospitals use IUCs more than any other medical device. Because the most important risk factor for catheter-associated bacteriuria is duration of catheterization, most catheters in hospitalized patients are placed for only 2 to 4 days.

    Extended indwelling catheter use in older adult patients sustaining hip fracture who are discharged to skilled nursing facilities with a catheter in place have been associated with poorer outcomes because these individuals are at higher risk of rehospitalization for CAUTIs and sepsis. Increased mortality at 30 days is seen in these individuals when compared to patients whose catheter was removed prior to discharge. In hospitalized older medical patients with UI, without a specific indication, an IUC has been associated with a greater risk of death - four times as great during hospitalization and two times as great within 90 days after discharge.

    The risk of infection is associated with the method and duration of catheterization, the quality of catheter care, and host susceptibility. Around 50% of hospitalized patients catheterized longer than 7 to 10 days contract bacteriuria.

    Although frequently asymptomatic, 20 to 30% of individuals with catheter-associated bacteriuria will develop symptoms of CAUTI. Many of these infections are serious and lead to significant morbidity and mortality. 

    Catheter Use in a Nursing Home

    The prevalence of indwelling urinary catheter use in nursing homes has been established as 5-7%.
    It may be greater in facilities that have poor success with toileting programs because the catheter is used as a means to maintain resident dryness.  
    At least 40% of all infections seen in nursing homes are in the urinary tract. Of these infections, 80% are due to urinary tract catheterization and instrumentation.  
    CAUTI is of major importance because of its effect on outcomes and treatment costs. The major reason for use of an indwelling catheter in LTC is incontinence or for healing a pressure injury.  

    Catheter Use in Home Care

    In the community, the prevalence of IUC is difficult to determine as many of the long-term IUC patients are lost to urologic follow-up and are managed by home care nurses or allied clinicians.  A National Home and Hospice Care Survey in 2007 reported catheter prevalence in home care (excluding hospice) at 9% (n= 4683) or 135,000 people with catheters of the 1.5 million home care patients in 2007. (http://www.cdc.gov/nchs/fastats/homehealthcare.htm).

     Alternatives to indwelling urinary catheter use

    1. Before placing an indwelling catheter, please consider if these alternatives would be more appropriate:

    • Bedside commode, urinal, or continence garments: to manage incontinence.
    • Bladder management through the use of a bladder scanner: to assess and confirm urinary retention, prior to placing catheter to release urine.
    • Straight catheterization: for one-time, intermittent, or chronic voiding needs.
    • External “condom” catheter: appropriate for cooperative men without urinary retention or obstruction.

    2. Before placing an indwelling catheter, does the patient have one of the following appropriate indications* for placing indwelling urinary catheters?

    • Acute urinary retention: e.g., due to medication (anesthesia, opioids, paralytics), or nerve injury
    • Acute bladder outlet obstruction: e.g., due to severe prostate enlargement, blood clots, or urethral compression
    • Need for accurate measurements of urinary output in the critically ill
    • To assist in healing of open sacral or perineal wounds in incontinent patients
    • To improve comfort for end of life, if needed
    • Patient requires strict prolonged immobilization (e.g., potentially unstable thoracic or lumbar spine, multiple traumatic injuries such as pelvic fracture)

    Selected peri-operative needs:

    • Urologic surgery or other surgery on contiguous (adjacent) structures of the genitourinary tract
    • Anticipated prolonged duration of surgery (Note: catheters placed for this reason should be removed in PACU)
    • Large volume infusions or diuretics anticipated during surgery
    • Need for intraoperative monitoring of urinary output

    indications iuc330d
    Click Here to View Indications for an Indwelling (Foley) Catheter

             

    References
    1. Centers for Medicare & Medicaid Services. Nursing Home Data Compendium. 2013. http://www.cms.gov/Medicare/Provider-Enrollment-andCertification/CertificationandComplianc /downloads/nursinghomedatacompendium_508.pdf.
    2. Fakih MG, Heavens M, Ratcliffe CJ, Hendrich A. First step to reducing infection risk as a system: evaluation of infection prevention processes for 71 hospitals. Am J Infect Control. 2013;41:950-54. doi:10.1016/j.ajic.2013.04.019
    3. Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA, HICPAC. Guideline for prevention of catheter associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010;31:319-26. doi: 10.1086/651091.
    4. Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA. Guideline for prevention of catheter‐associated urinary tract infections 2009. Infect Control Hosp Epidemiol;31:319‐26.
    5. Holroyd-Leduc JM, Sen S, Bertenthal D, Sands LP, Palmer RM, Kresevic DM, ………. Landefeld CS. The relationship of indwelling urinary catheters to death, length of hospital stay, functional decline, and nursing home admission in hospitalized older medical patients. Journal of the American Geriatrics Society, 2007;55;227–233.
    6. Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000;28(1):68-75.
    7. Saint S, Wiese J, Amory JK, et al. Are physicians aware of which of their patients have indwelling urinary catheters? Am J Med. 2000;109(6):476-480.
    8. Saint S, Kowalski CP, Kaufman SR, et al. Preventing hospital‐acquired urinary tract infection in the United States: a national study. Clin Infect Dis 2008;46:243‐50.  
    9. Saint S, Kaufman SR, Rogers MA, Baker PD, Ossenkop K, Lipsky BA. Condom versus indwelling urinary catheters: a randomized trial. J Am Geriatr Soc. 2006;54:1055‐61.  
    10. Schuur JD, Chambers JG, Hou PC. Urinary catheter use and appropriateness in U.S. emergency departments, 1995-2010. Acad Emerg Med. 2014 Mar;21(3):292-300. doi: 10.1111/acem.12334Urinary catheter use and appropriateness in U.S. emergency departments, 1995-2010. Acad Emerg Med. 2014 Mar;21(3):292-300. doi: 10.1111/acem.12334


    Published Date: January 14th, 2013


    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published January 15, 2013
  • Indications: External Urinary Catheters

    The use of an external urine collection device (EUCD) is an effective way to manage and collect urine leakage in men and women who have urinary incontinence. However, these devices are not indicated for the management of urinary obstruction or urinary retention. The 2009 CDC guidelines noted that an EUCD is an alternative to an indwelling urinary (Foley) catheter in male patients without urinary retention or bladder outlet obstruction.   

    Appropriate use:

    • Male or female patients who experience urinary incontinence (UI) without urinary retention including long term care residents in nursing homes, patients who are obese and have limited movement, and those patients with UI secondary to neurogenic lower urinary tract dysfunction (NLUTD) without sensory awareness due to paralyzing spinal disorders such as spinal cord injury, transverse myelitis, or progressive multiple sclerosis.
    • Patient/caregiver requests for an external device to manage and collect urine leakage.
    • For use in a male patient who has undergone prostate surgery (i.e. post-prostatectomy) who is experiencing stress incontinence who needs a containment system to return to work or usual activities (e.g., golfing).
    • Daily (not hourly) measurement of urine volume that is required (e.g. hospitalized patient) and cannot be assessed by other volume and urine collection strategies in acute care situations (e.g. acute renal failure work-up, bolus diuretics, fluid management in respiratory failure).
    • Single 24-hour or random nonsterile urine sample for diagnostic tests that cannot be obtained by other urine collection strategies.
    • To reduce or minimize acute, severe pain that is a result of movement when other urine management strategies are difficult (e.g. turning patient to remove an absorbent pad causes pain).
    • Managing overactive bladder symptoms and improving comfort in palliative care patients.
    • Use during the night to promote restful sleep and to reduce the risk for falls by minimizing the need to get up to urinate.

    Inappropriate use:

    • Any type of urinary retention (acute or chronic, with or without bladder outlet obstruction).
    • Any use in an uncooperative patient expected to frequently manipulate catheters because of such behavior issues as delirium and dementia.
    • Patient or family request in a patient who is continent when there are alternatives for urine containment (e.g. commode, urinal, or bedpan).
    • A need for a sterile urine sample for diagnostic tests where specimen obtained from an EUCD is not sterile.


    Written by: Diane K. Newman, DNP, ANP-BC, FAAN, Adjunct Professor of Urology in Surgery, Research Investigator Senior, Perelman School of Medicine, Co-Director, Penn Center for Continence and Pelvic Health, Division of Urology, University of Pennsylvania, Philadelphia, Pennsylvania

    Published Date: April 9th, 2020

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: 1. Conway, Laurie J., and Elaine L. Larson. "Guidelines to prevent catheter-associated urinary tract infection: 1980 to 2010." Heart & lung 41, no. 3 (2012): 271-283.
    2. Deng, Donna Y. "Urologic Devices." In Clinical Application of Urologic Catheters, Devices and Products, pp. 173-220. Springer, Cham, 2018.
    3. Geng, V., H. Cobussen-Boekhorst, H. Lurvink, I. Pearce, and S. Vahr. "Evidence-based guidelines for best practice in urological health care: male external catheters in adults urinary catheter management." Arnhem: European Association of Urology Nurses (2016).
    4. Gould, Carolyn V., Craig A. Umscheid, Rajender K. Agarwal, Gretchen Kuntz, David A. Pegues, and Healthcare Infection Control Practices Advisory Committee. "Guideline for prevention of catheter-associated urinary tract infections 2009." Infection Control & Hospital Epidemiology 31, no. 4 (2010): 319-326.
    5. Gray, Mikel, Claudia Skinner, and Wendy Kaler. "External collection devices as an alternative to the indwelling urinary catheter: evidence-based review and expert clinical panel deliberations." Journal of Wound, Ostomy, and Continence Nursing 43, no. 3 (2016): 301.
    6. Hooton, Thomas M., Suzanne F. Bradley, Diana D. Cardenas, Richard Colgan, Suzanne E. Geerlings, James C. Rice, Sanjay Saint et al. "Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America." Clinical infectious diseases 50, no. 5 (2010): 625-663.
    7. Newman, D. K. "Devices, products, catheters, and catheter-associated urinary tract infections." Core curriculum for urologic nursing. 1st ed. Pitman: Society of Urologic Nurses and Associates, Inc (2017): 439-66.
    8. Newman, Diane K., and Alan J. Wein. "External Catheter Collection Systems." In Clinical Application of Urologic Catheters, Devices and Products, pp. 79-103. Springer, Cham, 2018.
    9. Newman, D. K. "Devices, products, catheters, and catheter-associated urinary tract infections." Core curriculum for urologic nursing. 1st ed. Pitman: Society of Urologic Nurses and Associates, Inc (2017): 439-66.
    10. Tenke, Peter, Bela Kovacs, Truls E. Bjerklund Johansen, Tetsuro Matsumoto, Paul A. Tambyah, and Kurt G. Naber. "European and Asian guidelines on management and prevention of catheter-associated urinary tract infections." International journal of antimicrobial agents 31 (2008): 68-78.
    Published April 10, 2020
  • Indwelling Catheter Definition & Types

    What is an Indwelling Catheter?

    Indwelling Catheter Illustration

    An indwelling urinary catheter (IUC), generally referred to as a “Foley” catheter, is a closed sterile system with a catheter and retention balloon that is inserted either through the urethra or suprapubically to allow for bladder drainage. External collecting devices (e.g. drainage tubing and bag) are connected to the catheter for urine collection 

    Indwelling urinary catheters are recommended only for short-term use, defined as less than 30 days (EAUN recommends no longer than 14 days.) The catheter is inserted for continuous drainage of the bladder for two common bladder dysfunction: urinary incontinence (UI) and urinary retention.

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published January 15, 2013
  • Indwelling Urinary Catheters: Types

    Indwelling urinary catheters (IUCs) are semi-rigid, flexible tubes. They drain the bladder but block the urethra. IUCshave double lumens, or separate channels, running down it lengthwise. One of the lumen is open at both ends and allows for urine drainage by connection to a drainage bag.

    IUC-type1.png

    The other lumen has a valve on the outside end and connects to a balloon at the tip; the balloon is inflated with sterile water when it lies inside the bladder, and allows for retention in the bladder.  These are known as two-way catheters.  

    The name of the Foley catheter comes from the designer, Frederic Foley, a surgeon working in Boston, Massachusetts, in the 1930s. His original design was adopted by C. R. Bard, Inc. who manufactured the first prototypes and named them in honor of the surgeon.

    Foley Catheter Sizes

    Foley Catheter sizes chart
    Catheter sizes are colored-coded at the balloon inflation site for easy identification

    The relative size of a Foley catheter is described using French units (Fr).  In general, urinary catheters range in size from 8Fr to 36Fr in diameter. 1 Fr is equivalent to 0.33 mm = .013" = 1/77" in diameter.  

    The crosssectional diameter of a urinary catheter is equal to three times the diameter.

    Since urethral mucosa contains elastic tissue which will close around the catheter once inserted, the catheter chosen should be the smallest catheter that will adequately drain urine.  

    Size Considerations

    • The routine use of large-size catheters diameters can cause more erosion of the bladder neck and urethral mucosa, can cause stricture formation, and do not allow adequate drainage of peri-urethral gland secretions, causing a buildup of secretions that may lead to irritation and infection. 
    • Larger Fr sizes (e.g., 20-24 Fr) are most commonly used for drainage of blood clots.  
    • The most commonly utilized indwelling transurethral and suprapubic catheters range from 14 to 16Fr in both adult females and males. 
    • A 14 or 16 Fr is also the standard catheter in most commercially available IUC insertion kits or trays.
    • In adolescents, catheter size 14 Fr is often used but for younger children, pediatric catheter sizes of 6-12 Fr are preferred.  

    Shape and Design Variations

    Foley Catheter
    The distal end of most urinary catheters contains two ports (lumen or channel or dual lumen).  One is a funnel shaped drainage channel to allow efflux of urine once the catheter is placed and the other is the inflation/deflation channel for infusion of water into the retention balloon.  The infusion port for the balloon is usually labeled with the size of the balloon (5cc or 30 cc) and the size of the catheter.

    3 Way Indwelling Catheter 
    Three-way catheters are available with a third channel to facilitate continuous bladder irrigation or for instillation of medication.  This catheter is primarily used following urological surgery or in case of bleeding from a bladder or prostate tumor and the bladder may need continuous or intermittent irrigation to clear blood clots or debris. 


    Drainage Eyes
    The catheter should have a smooth surface with two drainage eyes at the tip that allow for urine drainage.

    Drainage eyes are placed either laterally or opposed. Opposing drainage eyes generally facilitate better drainage.

    Catheter products have changed significantly in their composition, texture, and durability since the 1990s.

    The challenge is to produce a catheter that matches as closely as possible to the normal physiological and mechanical characteristics of the voiding system, specifically the urethra and bladder. Foley catheters come in several subtypes, which are described in the area designs

    References

    1. Jahn P, Beutner K, Langer G. Types of indwelling urinary catheters for long-term bladder drainage in adults. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: CD004997. DOI: 10.1002/14651858.CD004997.pub3.Newman DK, Cumbee RP, Rovner ES. Indwelling (transurethral and suprapubic) catheters. In: Newman DK, Rovner ES, Wein AJ, editors. Clinical Application of Urologic Catheters and Products.  Switzerland: Springer International Publishing;2018,  47-77.
    2. Newman DK. Devices, products, catheters, and catheter-associated urinary tract infections. In: Newman DK, Wyman JF, Welch VW, editors. Core Curriculum for Urologic Nursing. 1st ed. Pitman (NJ): Society of Urologic Nurses and Associates, Inc; 2017, 439-66.
    3. Newman DK. The indwelling urinary catheter: Principles for best practice. JWOCN. 2007;34:655-61 DOI: 10.1097/01.WON.0000299816.82983.4a
    4. Newman DK, & Wein AJ. Managing and Treating Urinary Incontinence, Second Edition.  Baltimore: Health Professions Press;2009a;445-458.

    Published Date: January 25th, 2013

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published January 25, 2013
  • Intermittent Catheter Types

    The number of catheter types and designs has increased with the advancement of new technology. This has added complexity to the catheterization process for both the nurse and the patient

    General Considerations

    Intermittent catheter types and sizes

    Catheter Sizing

    Catheter types are now gender specific, acknowledging the anatomical differences in urethral length between men and women.

    • Standard male catheter length is 16” (~40cm)
    • Female catheters range in length from 6-12
    • Pediatric lengths are 6-10”.

    Many women find that shorter catheters do not shift and are easier to grasp and insert.

    Measurement Units

    A catheter diameter is measured in French units, similar to the size of indwelling urinary catheters.  Sizes range from 6-12 French for children and 14-22 French for adults. The funnel end of the catheter is often color coded to allow for easier size identification.  

    Catheter Sizes

    Packaging

    Some catheters are sold individually packaged, are more compact, and can be easily carried in a purse or pocket.  

    Different style of intermittent catheter packaging

    Intermittent Catheter Types

    There are two main designs of catheters used for intermittent bladder drainage: coated and uncoated.

    Noncoated

    Noncoated catheters require separate external gel lubrication, before insertion and catheters with a coating that provides the lubrication when water is applied.  Uncoated red rubber catheters are not appropriate for anyone with latex sensitivities and the flexibility of a red rubber catheter can make it difficult to insert.

    Coated

    Coated catheters are designed to improve catheter lubrication and ease of insertion, which may reduce trauma and urinary tract infections. The most common coating is a hydrophilic coating as there is evidence supporting single-use HC catheters’ ability to prevent some of the most common catheter-associated complications, such as urethral trauma and CaUTIs.   

    In addition, design changes include the integration of all needed equipment (such as catheter, water-based lubricant, and drainage receptacle/ bag) into a compact and user-friendly system (closed system). The clinician who instructs the patient usually recommends the catheter choice, so knowledge of the different types of catheters is important.

    Impact of Packaging

    Standalone catheter

    The type of catheter packaging can be decisive in the choice of a catheter. Consideration is made to the general clinical condition of the patient (injury, hand dexterity, any visual impairment, urethral considerations, gender, and age, are also considered before the cause of the bladder dysfunction.

    The patient may need to try several catheters before finding the preferred type. Often patients require one type of catheter for use in their home and another for use when traveling or working or bring away from their own home.

    Comparison of Types

    Types

    Characteristics

    Concerns

     Non-coated

    • Most commonly used catheter - made of medical-grade plastic (PVC) or silicone
    • Available in range of stiffness
    • Generally packaged with a seperate gel. Usually in a foil packet that must be opened and applied directly to the catheter prior to insertion.

     

    • Applying the lubrication gel is an extra step, can be messy, and can be difficult to ensure complete lubrication of the entire catheter.

     

     Hydrophilic coated (HC) 

     

    • Have a polymer coating that adheres to the catheter surface that becomes slippery and smooth when wet. Coating ensures lubrication of the entire urethra during the catheter insertion and withdrawal, thereby reducing the coefficient of friction by at least 95%. Developed with the goal of reducing trauma during the catherterization process.

     

    • Becomes slippery and the sleeve provides ease for the patient to grasp and manipulate for insertion.
    • Single use only.
    • May not be covered by patients medical insurance.

     Closed systems

    • Gel
    • Hydrophilic
    • Antibacterial 
    • Pre-lubricated intermittent catheter with an attached collection bag and often includes a protective introducer tip
    • All inclusive - includes gloves, drape, underpad, antiseptic wipe or swabs 
    • Allows user to catheterize without touching the catheter 
    • Used for sterile technique 
    • Can be difficult for some with limited dexterity to advance the catheter through the collection bag
    • Single use only 

     

    Video Lecture - Catheter Types and Designs


    ic types designs part1

     


    animation

    References

    1. Chartier-Kastler E, Amarenco G, Lindbo L, et al. A prospective, randomized, crossover, multicenter study comparing quality of life using compact versus standard catheters for intermittent self-catheterization. J Urol. 2013;190(3):942-947.
    2. Christison K, Walter M, Wyndaele JJM, et al. Intermittent catheterization: The devil is in the details. J Neurotrauma. 2018 Feb 1. doi: 10.1089/neu.2017.5413doiChristison K, Walter M, Wyndaele JJM, et al. Intermittent catheterization: The devil is in the details. J Neurotrauma. 2018 Feb 1. doi: 10.1089/neu.2017.5413
    3. DeFoor W, Reddy P, Reed M, et al. Results of a prospective randomized control trial comparing hydrophilic to uncoated catheters in children with neurogenic bladder. J Pediatr Urol. 2017.
    4. Goetz LL, Droste L, Klausner AP, Newman DK. Catheters Used for Intermittent Catheterization. Clinical Application of Urologic Catheters, Devices and Products. Cham: Springer International Publishing; 2018:47-77.
    5. Håkansson MA. Reuse versus single-use catheters for intermittent catheterization: what is safe and preferred? Review of current status. Spinal Cord. 2014;52(7):511-516.
    6. Newman DK. Devices, products, catheters, and catheter-associated urinary tract infections. In: Newman DK, Wyman JF, Welch VW, editors. Core Curriculum for Urologic Nursing. 1st ed. Pitman (NJ): Society of Urologic Nurses and Associates, Inc; 2017. p.439-66.
    7. Newman DK, Willson MM. Review of intermittent catheterization and current best practices. Urol Nurs. 2011 Jan-Feb;31(1):12-28, 48; quiz 29. PubMed PMID: 21542441
    8. Rognoni C, Tarricone R. Intermittent catheterization with hydrophilic and non-hydrophilic urinary catheters: systematic literature review and meta-analyses. BMC Urol. 2017;17(1):4.
    9. Shamout S, Biardeau X, Corcos J, Campeau L. Outcome comparison of different approaches to self-intermittent catheterization in neurogenic patients: a systematic review. Spinal Cord. 2017;55(7):629-643.
    10. Sun AJ, Comiter CV, Elliott CS. The cost of a catheter: An environmental perspective on single-use clean intermittent catheterization. Neurourol Urodyn. 2018;37(7):2204-2208.


    Last Updated: August 2019

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published March 3, 2020
  • Introduction: External Urinary Catheters

    External urinary catheters (EUC) are used as collection devices or systems (referred in the UroToday reference center as external urine collection devices [EUCD]) for collecting and containing urine via tubing that relies on gravity to drain urine away from the penis or perineum into a drainage bag or suction that pulls urine into a container.
    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: 1. Beeson, Terrie, and Carmen Davis. "Urinary management with an external female collection device." Journal of Wound, Ostomy, and Continence Nursing 45, no. 2 (2018): 187.
    2. Cottenden A, Fader M, Beeckma D, Buckley B, Kitson-Reynolds E, Moore K, Nishimura K, Ostaszkiewicz J, Watson J, Wilde M. (2017) "Management using continence products." In P. Abrams, L. Cardozo, S. Wagg, A. Wein. (Eds.). Incontinence: Proceedings from the 6th International Consultation on Incontinence (pp.2342-2346). ICUD ICS Publications
    3. Deng, Donna Y. "Urologic Devices." In Clinical Application of Urologic Catheters, Devices and Products, pp. 173-220. Springer, Cham, 2018.
    4. Fader, Mandy, Donna Bliss, Alan Cottenden, Katherine Moore, and Christine Norton. "Continence products: research priorities to improve the lives of people with urinary and/or fecal leakage." Neurourology and Urodynamics: Official Journal of the International Continence Society 29, no. 4 (2010): 640-644.
    5. Geng, V., H. Cobussen-Boekhorst, H. Lurvink, I. Pearce, and S. Vahr. "Evidence-based guidelines for best practice in urological health care: male external catheters in adults urinary catheter management." Arnhem: European Association of Urology Nurses (2016).
    6. Gould, C. V., C. A. Umscheid, R. K. Agarwal, G. Kuntz, and D. A. Pegues. "HICPAC." Guideline for prevention of catheter–associated urinary tract infections. CDC (2009). Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. DOI: 10.1086/651091. PubMed PMID: 20156062.
    7. Gray, Mikel, Claudia Skinner, and Wendy Kaler. "External collection devices as an alternative to the indwelling urinary catheter: evidence-based review and expert clinical panel deliberations." Journal of Wound, Ostomy, and Continence Nursing 43, no. 3 (2016): 301.
    8. Lachance, Chantelle C., and Aleksandra Grobelna. "Management of Patients with Long-Term Indwelling Urinary Catheters: A Review of Guidelines." (2019).
    9. Newman DK. (2017). "Devices, products, catheters, and catheter-associated urinary tract infections." In: Newman DK, Wyman JF, Welch VW, editors. Core Curriculum for Urologic Nursing. 1st ed. Pitman (NJ): Society of Urologic Nurses and Associates, Inc; 439-66.
    10. Newman, Diane K., and Alan J. Wein. "External Catheter Collection Systems." In Clinical Application of Urologic Catheters, Devices and Products, pp. 79-103. Springer, Cham, 2018.
    Published April 10, 2020
  • New Data Demonstrating Enobosarm’s Potential to Treat Stress Urinary Incontinence -Presented at SUFU 2018.

      -- MRI results show increases in pelvic floor muscle and urethral muscle diameter supporting enobosarm’s mechanism of action --

      -- Additional positive results in subset of postmenopausal women suggest dual treatment effect on urge incontinence and stress urinary incontinence --

    TRUCKEE, California.--(UroToday)--Additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence (SUI), including magnetic resonance imaging (MRI) results from patients’ pelvic floor muscle. 
    Published March 11, 2018
  • Nocturia: A Nighttime Condition with Daytime Consequences

    Michael, a 61-one-year old executive accountant, presents for annual PSA monitoring and digital rectal examination. He reports that alpha-blocker therapy using tamsulosin has improved his benign prostatic hypertrophy, but that he still wakes frequently at night to void. He is otherwise healthy except for a history of type 2 diabetes mellitus that is well controlled with metformin. He views his nighttime trips to the bathroom as a normal part of aging (“all my friends have the same problem”). Michael’s wife, who has attended the appointment with him, interjects that Michael’s trips to the bathroom wake her and so she is tired during the day. On further questioning, Michael reports that he has trouble concentrating during his many meetings, and that he feels tired and sleepy during his drive home from work. How might we best manage his care?

    Michael’s case mirrors those seen frequently in many urology practices. Nocturia, the most common lower urinary tract symptom affecting men and women of all ages, has numerous negative effects on physical and mental health, productivity, and quality of life.4 At the same time, prevailing misconceptions and a historic lack of safe, effective therapies for nocturia have created a striking treatment gap. 4,34,35,48 In this article, we review the definition, prevalence, and etiologies of nocturia and behavioral and medical treatment options. We then focus on the clinical profile and development of NOCTIVATM(desmopressin acetate), a proprietary and novel nasal spray of vasopressin analog that is the first medication approved in the United States for adults with nocturia due to overproduction of urine at night.5,32 We conclude by discussing practical strategies for the safe, effective initiation and continuation of NOCTIVATMtherapy in clinical practice.

    Definition and Epidemiology 

    The International Continence Society (ICS) defines nocturia as waking at least once at night to void, with each void preceded and followed by sleep.3 This definition excludes first morning void (the first void after waking with the intention to rise).3 Left untreated, nocturia significantly reduces daytime functioning, mood, and quality of life, and increases the risk of falls, injuries, and mortality. 4,6,8,42,28 Multiple studies indicate that waking just twice at night to void is bothersome and has clinically significant effects.76,2,16,13 Thus, when considering nocturia as a condition of the lower urinary tract, voiding two or more times a night is viewed as clinically meaningful.

    Despite these serious consequences, nocturia has been chronically understudied, underdetected, and underreported. 4 Patients often do not disclose their nocturia to healthcare providers because they are reluctant to discuss toileting or do not connect their nocturia with other signs and symptoms they may be experiencing.41,51 Additionally, many patients, and some clinicians, misperceive nocturia as a benign and natural part of aging or as merely a symptom of benign prostatic hypertrophy in males or overactive bladder in males and females.25

    In reality, nocturia frequently arises independently of overactive bladder and benign prostatic hypertrophy and is the most common lower urinary tract symptom affecting adults of both sexes and all ages.4,6,8,26,49,50,51,52,18

    In a systematic review and meta-analysis of 43 studies published between 1990 and 2009, between 2% and 18% of adults in their 20s to 40s reported waking at least twice nightly to void, as did 29% to 59% of men and 28% to 61.5% of women aged 70 and older.26 In another study of more than 5,200 men participating in the National Health and Nutrition Examination Survey (NHANES), the prevalence of nocturia ranged from 8.2% among those aged 20 to 34 years to 55.8% among those aged 75 years or more.18

    Nocturia also is highly prevalent among adults from diverse ethnic groups. In a population-based study of rural community health centers in Korea, 87% of men and 86% of women aged 65 years and older reported waking at least once nightly to void.49 In another population-based study of more than 4,100 adults aged 40 years and older in China, approximately 75% of individuals reported waking at least once per night to void and more than 33% did so at least twice nightly.51 In a population-level study of reproductive-aged women in Turkey, approximately one-third of those in their 20s and 30s reported waking at least once per night to void, as did approximately 46% of women in their 40s.56 Finally, in a population-based study of female primary care patients aged 18 to 85 years in Brazil, approximately 58% reported waking at least once nightly to void.52

    Consequences of Nocturia 

    The many negative effects of nocturia hinge on its impact on sleep. Sleep consists of two main states: rapid eye movement (REM) sleep, which comprises approximately 25% of total sleep time and is implicated in mental functioning, and non-REM (NREM) sleep, which makes up approximately 75% of total sleep time and is concerned with homeostatic processes.14,60

    Importantly, NREM sleep includes four stages: the transition from wakefulness to sleep (stage 1), light sleep (stage 2), and deep, restorative, slow-wave sleep (stages 3 and 4).14Because stages 3 and 4 occur during the first 4 hours of sleep, waking during this time decreases restorative slow-wave sleep even if there are no major changes in REM and NREM time. 14,60Persons who wake at least twice per night in order to void usually sleep only 2 to 3 hours before their first trip to the bathroom.6,15 This curtails their first uninterrupted sleep period, which reduces slow-wave sleep and leads to greater daytime fatigue and sleepiness, a lower pain threshold, longer reaction times, and reductions in psychomotor performance, attention span, and memory.19,78,7

    Nocturia is usually a chronic condition. The repetitive nature of the sleep disruption is likely why nocturia also significantly increases the risk of somatic diseases, emotional symptoms, motor vehicle accidents, falls, fractures, and mortality.19,62,59,65,66,67,20,22,68 In a large cross-sectional study of adults in the United States, nocturia correlated strongly with cardiovascular disease, hypertension, and stroke, even after controlling for known confounders such as comorbid diabetes and respiratory sleep disorders.62 In another large study of adults in Minnesota, nocturia was independently associated with coronary heart disease among men younger than 60 years.23 Other studies have linked poor sleep due to nocturia with immune and inflammatory dysregulation and aberrant glucose metabolism, which in turn are associated with diabetes mellitus, the metabolic syndrome, cardiovascular disease, and numerous other chronic diseases.63,64,59

    Researchers also have linked nocturia with an increased risk for anxiety and mood disorders. A recent review of 12 population-based studies identified a bidirectional association between nocturia and depression and anxiety.57 In another study of more than 5,500 adults who responded to the Boston Area Community Health survey, the severity of nocturia correlated with depression among both men and women, even after controlling for covariates such as age, ethnicity, smoking, and socioeconomic status.17 Although the association was strongest among younger individuals, nocturia increased the odds of depression more than three-fold among women reporting sleep disturbances due to urologic symptoms (adjusted odds ratio [OR], 3.37; 95% confidence interval [CI], 1.63-6.94). 17 Finally, in a population-based study of rural Koreans, individuals with nocturia reported adverse emotional effects, lower energy levels, and reduced daytime functioning.49

    Falls during nighttime toileting increase the risk of fracture and mortality, and these risks increase with increasing numbers of nocturic episodes per night.20 In a recent longitudinal study of approximately 1,800 middle-aged and older men who were followed for an average of 6.2 years, rates of hip fracture were 2.7% among men who rose at least twice nightly to void but only 1.0% among men who rose once nightly and 0.9% among men without nocturia. Rising at least twice per night to void significantly increased the risk of hip fracture regardless of age (adjusted OR, 1.36; 95% CI, 1.03-1.80; P=.03).68 In another 5-year observational study of elderly adults in Japan, those with two or more nocturic episodes per night were at significantly increased risk of falls leading to fracture (hazard ratio [HR], 2.20; 95% CI, 1.04-4.68; P=.04) and death (HR, 1.91, 95% CI, 1.07-3.43; P=.03).22 Nocturia remained a significant risk factor for mortality even after controlling for smoking, comorbidities, and medications that increase the likelihood of falls, such as tranquilizers and hypnotics (HR, 1.98, 95% CI, 1.09-3.59; P=.03). 22

    Several other studies also have linked nocturia with an increased risk for mortality. 23,21 In a multivariate analysis of NHANES data from adults aged 20 years and older, awakening at least twice nightly to void correlated significantly with mortality, particularly among individuals younger than 65 years.21 The study authors hypothesized that the health effects of chronic sleep disruption from nocturia ultimately increased the risk of death.

    Finally, clinically significant nocturia can erode nearly all aspects of health-related quality of life. In a study of more than 3,500 adults in Finland aged 18 to 79 years, those with at least two nocturic episodes per night scored significantly lower on 14 of 15 dimensions of health-related quality of life as measured by the generic 15D instrument.13 The negative effects of nocturia were similar in both genders. 13 In another recent qualitative study of 20 adults in the United States who averaged three nocturic episodes per night, nocturia was associated with high levels of daytime fatigue, poor emotional well-being, and reduced social and cognitive functioning that limited respondents’ ability to work and perform daily activities.43

    The adverse effects of the chronic nature of nocturia are costly. In a recent study, researchers analyzed data from the Boston Area Community Health Study, the U.S. Bureau of Labor Statistics, and the Work Productivity and Impairment questionnaire.42 They concluded that at least 28 million U.S. adults rise at least twice nightly to void, incurring 127 lost hours of productivity per person every year, $61 billion in economic losses, and at least $1.5 billion in health care costs related to falls.42

    Etiologies and Assessment of Nocturia 

    The assessment of patients with nocturia should begin with a thoughtful consideration of its etiology or etiologies. It is helpful to keep in mind that awakening (or not) because of the need to void is a product of the relationship between the amount of urine produced at night and the ability of the bladder to store it.9 Normal nocturnal bladder capacity depends on many factors, including near-complete bladder emptying, low nighttime intracystic pressure, normal bladder sensation during filling, adequate sphincter function (no stress incontinence), a lack of involuntary contractions (no bladder overactivity), and a lack of excess urine production at night.9,10,78, 4,11,12Derangements in any of these variables can lead to clinically significant nocturia.

    Thus, nocturia can result from nocturnal or global polyuria, bladder storage problems, psychologic factors and sleep disturbances, fluid intake behaviors, medications, or mixed syndromes.27,24,29,3,30,31 Among these etiologies, by far the most prevalent is nocturnal polyuria, which the International Continence Society defines as the nighttime production of more than 33% of total 24-hour urine volume by adults aged 65 years and older, and the nighttime production more than 20% of total 24-hour urine volume by younger adults.3,30 Nocturnal polyuria becomes more common with age, but it is the most common cause of nocturia in all age groups has been implicated in up to 80% of cases of nocturia.27,25,3

    It is important to distinguish nocturnal polyuria from global polyuria, defined as total 24-hour urine output greater than 40 mL per kg of body weight.3,30 A frequency-volume assessment helps differentiate these two syndromes: Patients record the time and volume of each void, typically for 3 days.25 The sum of each nighttime void volume and the first morning void volume is then divided by the total 24-hour urine volume.

    When evaluating a nocturic adult, physicians also should consider the possible role of fluid intake behaviors, congestive heart failure, type 2 diabetes, peripheral edema due to venous disease, overactive bladder (increased urinary urgency and frequency that may or may not involve nocturia) in men and women, and benign prostatic hypertrophy in men.45  Mood and anxiety disorders are common comorbidities; it is helpful to ask if patients are waking because they need to void or are deciding to use the bathroom once awake (nocturnal convenience void).53 Short, self-administered screening tools such as the Hospital Anxiety and Depression Scale (HADS) and the Geriatric Depression Scale (GDS) are not commonly used in urology practice but are feasible to deploy and can help identify patients whose nocturia and overall well-being might benefit from mental health care.57,58

    Physicians should also ask nocturic patients about respiratory sleep disorders, which are another common comorbidity.45 In particular, obstructive sleep apnea causes pulmonary vasoconstriction and hypoxia, leading to increased atrial natriuretic peptide levels, renal sodium and water excretion, and nocturia.53 In recent prospective and retrospective studies of adults with obstructive sleep apnea, severity correlated with nocturic episodes per night, and patients who were treated with continuous positive airway pressure (CPAP) showed a subsequent improvement in nocturia.46,47

    In summary, when assessing patients with nocturia, it is important to keep in mind that nocturnal polyuria is very often the cause, but also to look for global polyuria, overactive bladder, benign prostatic hypertrophy, and somatic, psychiatric, and respiratory sleep disorders. Nocturia is complex and multifactorial; a tailored approach to management maximizes the likelihood of treatment response and should involve multidisciplinary approaches, when appropriate.

    Treatment Considerations 

    Conventionally, the management of nocturia begins with lifestyle changes and behavioral therapy. Patients should be encouraged to restrict fluid intake after early evening, restrict caffeine and alcohol, take diuretics in the mid-afternoon, elevate their legs in the evening to help mobilize fluids, and void immediately before bed. However, behavior modification alone tends to be ineffective and not durable.25,33 Patients usually cannot maintain such extensive lifestyle changes, and fluid restriction is ineffective if patients have subnormal levels of circulating vasopressin.34,35,10

    Unfortunately, there also has been a historic lack of safe, effective medications for nocturia. Approved treatments for overactive bladder and benign prostatic hypotrophy have been prescribed off-label for nocturia but are usually ineffective. This is because nocturia is primarily a “kidney” condition; most cases are due to nocturnal polyuria, or the excessive production of urine at night by the kidneys due to alterations in circulating vasopressin.29,25Medications for overactive bladder and benign prostatic hypertrophy target “downstream” organs: the bladder (anticholinergics/antimuscarinics and β3-adrenergic agonists) and the prostate gland (⍺-blockers).39,40,41,33,24,25

    A more effective approach to treating nocturia is to administer a synthetic analog of vasopressin. Vasopressin or antidiuretic hormone acts on V receptors 1, 2, and 3) to induce vasoconstriction, osmoregulation, and corticotropin secretion.69 In the renal collecting tubule, vasopressin activates the V2 receptor, which increases production of the aquaporin-2 water channel and its migration to the apical plasma membrane.54The result is greater osmotic water permeability, increased water reabsorption in the distal tubule and collecting ducts, and decreased urine production.55,53

    Desmopressin is a synthetic analog of arginine vasopressin that selectively targets the V2 receptor, thereby retaining the antidiuretic properties of vasopressin without exhibiting its unwanted pressor activity.25 Desmopressin was first approved in the United States in oral form.36 In a systematic review and meta-analysis of 10 randomized trials comparing oral desmopressin or placebo in 2,191 healthy adults with nocturia, desmopressin (100 micrograms [mcg]) extended the first uninterrupted sleep period by more than 1 hour in most patients and decreased nocturic episodes by a mean of 0.72 events per night.38Compared with placebo, however, desmopressin was associated with a five-fold increase in the risk of hyponatremia at doses of 10 mcg or more (relative risk, 5.1; 95% CI, 3.0-8.8).38 In two other randomized trials of oral desmopressin in nocturic women and men, 34% and 46% of treated patients had fewer than half the number of voids compared with baseline, compared with 3% of 7% of patients in the placebo groups.35,37

    These efficacy data for desmopressin are important because improving or resolving clinically significant nocturia can significantly improve sleep architecture, leading to more restorative sleep. In a recent post-hoc analysis of data from three clinical trials of 841 nocturic adults (90% of whom had nocturnal polyuria), treatment with desmopressin was associated with significant increases in first uninterrupted sleep period, even after accounting for numerous demographic and clinical covariates.61 In another post-hoc analysis of clinical trial data, treatment with desmopressin lengthened first uninterrupted sleep period, leading to improvements on nearly all subscales of the Pittsburgh Sleep Quality Index.75Finally, in a study of 105 men treated for nocturia, those who responded to treatment (waking at least once less during the night to void) experienced a 1.8-hour mean increase in first uninterrupted sleep period, while non-responders averaged a 0.6-hour decrease in first uninterrupted sleep period during follow-up.

    However, oral desmopressin tablets are not FDA-approved for the treatment of nocturia due to nocturnal polyuria and are seldom used in urology practice.81,Barkin,48 In a recent retrospective study of 403 adults seen in tertiary urology practice for the primary complaint of nocturia, 76% of patients had nocturnal polyuria but only 5% used oral desmopressin.48 Notably, the completion of bladder diaries did not improve nocturia, underscoring the limitations of behavioral therapy.48 A sublingual melt formulation of desmopressin has recently been approved by the FDA for the treatment of nocturia in adults but is not yet commercially available.80 Likewise, an older intranasal spray formulation of desmopressin been found to improve nocturnal polyuria in men with benign prostatic hypertrophy.53,70 but is not approved for the treatment of nocturia.31

    NOCTIVA 

    In March 2017, the U.S. Food and Drug Administration approved NOCTIVA for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least twice nightly to void.79 NOCTIVA is a preservative-free proprietary emulsification of desmopressin acetate and cyclopentadecanolide, a permeation enhancer that facilitates rapid absorption of desmopressin across the nasal mucosa and allows for use of a lower dose.79,5, 1 The bottle is also designed to deliver a unique spray pattern that maximizes the distribution of the emulsification throughout the nasal cavity. These unique characteristics of NOCTIVA facilitate microdosing, rapid absorption, and pharmacokinetic consistency from dose to dose. Two FDA-approved dosing bottles are available: NOCTIVA 1.66 mcg and NOCTIVA 0.83 mcg.

    The NOCTIVA development program included 10 studies: two phase 1 trials, one phase 2 trial, four phase 3, double-blind, placebo-controlled trials, one phase 3 open-label study in elderly patients, and two open-label, long-term safety extension trials.74 In this article, we focus on the results of the most recent double-blind phase 3 trials and the long-term extension trials.

    Pivotal Trials: Design and Patients 

    The safety and efficacy of NOCTIVA 1.66 mcg and NOCTIVA 0.83 mcg were evaluated in two multicenter, randomized, double-blind, placebo-controlled phase 3 trials (DB3 and DB4). 1 The intention-to-treat population consisted of 1,333 adults aged 50 years and older who averaged 3.3 nocturic voids per night during screening.

    Co-primary endpoints in both trials were change from baseline in mean number of nocturic episodes per night and percentage of patients achieving at least a 50% reduction in nocturic episodes per night.

    Secondary efficacy endpoints included nocturnal urine volume, first uninterrupted sleep period (time from bedtime to the first nocturic void), percentage of nights in which patients had one or no nocturic voids.

    The DB4 study also assessed the change from baseline in scores on the Impact of Nighttime Urination (INTU) questionnaire, a validated 10-item tool that assesses the clinical meaningfulness (based on patient perceptions) of reducing nocturic episodes per night.71,72  The daytime impact domain of the INTU tool assesses concentration, tiredness, ability to complete activities, irritability, restfulness, and daytime drowsiness, while the nighttime domain assesses bother, premature waking, insufficient sleep, and level of emotional concern about needing to get out of bed to urinate. The overall score ranges from 0 to 100, with 100 representing the greatest detrimental impact of nocturia. Patients in the DB4 study completed three INTU questionnaires that corresponded with three voiding diaries.

    During the 2-week lead-in periods, patients received intranasal placebo spray every night and completed two 3-day nightly voiding diaries. At[DR1]  the end of the lead-in periods, all patients were randomly assigned to receive NOCTIVA 1.66 mcg (containing  0.75 mcg desmopressin), NOCTIVA 0.83 mcg (containing 1.5 mcg desmopressin), or placebo. Study drug and placebo were administered intranasally every night, and efficacy and safety assessments were performed every 2 weeks. 1 No fluid restrictions or other behavioral changes were imposed on study participants. The second trial (DB4) also evaluated an intermediate dose of NOCTIVA containing 1.0 mcg desmopressin .

    Most (57%) trial participants were male, and mean age was 66 years (range, 50-90 years). 1 Investigator-assessed etiologies of nocturia included nocturnal polyuria, overactive bladder, benign prostatic hypertrophy, global polyuria, and unknown causes. The trial arms were well-matched for these etiologies and for demographic and clinical characteristics. Key exclusion criteria included nocturnal enuresis, diabetes insipidus, unstable diabetes mellitus, obstructive sleep apnea, New York Heart Association class 2 to 4 congestive heart failure, a documented history of polydipsia, uncontrolled hypertension (systolic pressure >165 mm Hg and diastolic pressure >100 mm Hg), unstable angina, syndrome of inappropriate antidiuretic hormone secretion (SIADH), severe daytime lower urinary tract symptoms with more than 8 daytime voids per day, prior treatment with desmopressin for nocturia, and illness requiring systemic corticosteroid therapy. Concomitant medications for benign prostatic hypertrophy and overactive bladder were permitted if patients had been on stable doses for the past 6 months and did not change these doses during the study.

    NOCTIVA Met Endpoints in Phase 3 Trials

    Both doses of NOCTIVA achieved statistical significance for the two co-primary endpoints in a pooled analysis of data from both trials. 1 On average, nocturic voids decreased by 1.5 episodes with NOCTIVIA 1.66 mcg and by 1.4 episodes with NOCTIVA 0.83 mcg, versus a reduction of 1.2 episodes with placebo (each P<0.0001). Results were similar in each individual trial. In the pooled analysis, the percentage of patients who experienced at least a 50% reduction in mean nocturic episodes per night was 48.7% in the 1.66-mcg group and 37.9% in the 0.83-mcg group versus 30.3% in the placebo group (P<.0001 and P=.0055, respectively). NOCTIVA 1.66 mcg showed a statistically significant effect for this co-primary endpoint in each individual trial, whereas NOCTIVA 0.83 mcg showed a statistically significant effect only in the pooled analysis.

    Both doses of NOCTIVA also significantly reduced nocturnal urine production compared with placebo. In the pooled analysis, nocturnal urine volume at baseline was approximately 805 mL in all three pooled treatment groups. At week 12, mean reductions in nocturnal urine volume were 259.7 mL in the pooled 1.66-mcg group and 195.2 mL in the 0.83-mcg group versus 132.7 mL in the placebo group (P<.0001 and P=.0025, respectively). Results were similar in the individual trials.

    As we have discussed, waking during the first 3 to 4 hours of sleep interrupts restorative sleep, leading to next-day fatigue, discomfort, and a decreased pain threshold.14 NOCTIVA significantly increased first uninterrupted sleep periods in the pooled analysis of data from both  trials. Mean increases were 108 minutes in the 1.66-mcg group and 96 minutes in the 0.83-mcg group versus 72 minutes in the placebo group (each P<.0001). 1 By the end of treatment week 12, first uninterrupted sleep periods averaged 252 minutes (i.e., 4.2 hours) in the 1.66-mcg group and 240 minutes (4.0 hours) in the 0.83-mcg group, versus 210 minutes (3.5 hours) in the placebo group (each P<.0001).10

    Compared with placebo, NOCTIVA also significantly increased the percentage of nights in which patients had either no nocturia or a single nocturic episode. 1These percentages were 46.6% in the 1.66-mcg group and 39.9% in the 0.83-mcg group versus 33.8% in the placebo group in the pooled analysis (P<.0001 and P=.012, respectively). NOCTIVA 1.66 mcg produced a statistically significant effect for this secondary endpoint in each trial, whereas NOCTIVA 0.83 mcg reached statistical significance in the pooled analysis but not in the individual trials. In the pooled analysis, the percentages of nights with no nocturic episodes were 10.9% with NOCTIVA 1.66 mcg and 8.2% with NOCTIVA 0.83 mcg versus 5.3% with placebo (P<.0001 and P=.020, respectively).

    In summary, NOCTIVA 1.66 mcg and NOCTIVA 0.83 mcg met co-primary and secondary endpoints in the pooled analysis of data from both trials. NOCTIVA 1.66 mcg also met these endpoints in each of the two individual trials, despite a considerable placebo response. The reason for this placebo response remains unclear. Education regarding lifestyle modifications might have played a role, although patients were instructed not to alter their usual fluid intake .

    NOCTIVA also shows durable efficacy. In addition to the double-blind trials, two phase 3, open-label studies evaluated NOCTIVA 0.83 mcg for up to 43 weeks and NOCTIVA 1.66 mcg for up to 126 weeks. In both studies, NOCTIVA reduced nocturic episodes by approximately two episodes per night from baseline, and this improvement persisted throughout follow-up.

    Impact on Daily Life 

    The higher 1.66-mcg dose of NOCTIVA was associated with significant improvements in patient-reported quality of life. 1 In the DB4 trial, NOCTIVA 1.66 mcg produced significant improvements from baseline in the overall INTU impact score (P=.0255) and in the nighttime domain score (P=.0118). Overall impact scores decreased by a mean of 14.1 points in the 1.66-mcg group, 12.4 points in the 0.83-mcg group, and 11.5 points in the placebo group. 1 Nighttime domain impact scores decreased by a mean of 18.0 points in the 1.66-mcg group, 16.0 points in the 0.83-mcg group, and 14.5 points in the placebo group. Differences in overall and nighttime impact scores between the 0.83-mcg group and the placebo group did not reach statistical significance.

    Safety

    NOCTIVA demonstrated an acceptable safety profile. Nasal discomfort and nasopharyngitis were the most common treatment-related adverse events in the two double-blind trials. These usually were mild to moderate in severity and affected similar proportions (2.6% to 5.6%) of individuals in the treatment and placebo arms. 1 The incidence of serious adverse events also was similar among arms (2% in the NOCTIVA 1.66 and 0.83 mcg groups and 3% in the placebo group). In the 1.66-mch arm, there was one case each of serious treatment-emergent hyponatremia and worsening hypertension that were considered probably related to treatment.

    A total of 5.9% of patients in the pooled analysis discontinued treatment due to adverse effects, most commonly nasal symptoms such as congestion, rhinorrhea, sinus discomfort, and throat irritation. 1 Hyponatremia developed 6 days to 12 weeks after treatment initiation and affected similar proportions of men and women. The proportion of patients who developed serum sodium levels between 130 and 134 mmol/L was 11.2% in the 1.66-mcg group, 8.4% in the 0.83-mcg group, and 4.4% in the placebo group. The proportion of patients who developed serum sodium levels in the 126 to 129 mmol/L range was 2.0% in the 0.83-mcg and 1.66-mcg groups and 0% in the placebo group.

    The incidence of moderate to severe  hyponatremia (serum sodium 125 mmol/L or less regardless of symptoms or less than 130 mmol/L with symptoms) was 1.1% in the 1.66-mcg group, 0% in the 0.83-mcg group, and 0.2% in the placebo group. 1 All five patients in the 1.66-mcg group who developed serum sodium levels of 125 mmol/L or less were older than 65 years, and four were receiving contraindicated medications (inhaled or systemic corticosteroids). 1 The only placebo patient who developed a serum sodium level less than 125 mmol/L also was older than 65 years. Nausea and vomiting consistent with hyponatremia affected one patient each in the 1.66-mcg and placebo groups.

    NOCTIVA has not been compared with other formulations of desmopressin in head-to-head trials.10 However, it is noteworthy that even though the DB3 and DB4 trials did not impose fluid restrictions and 54.5% of participants were 65 years or older,1 the incidence of hyponatremia was generally less than that in studies of oral and orally disintegrating desmopressin formulations (3% to 16%).73 However, because NOCTIVA contains desmopressin, its prescribing label includes a boxed warning for hyponatremia.79 Clinicians should avoid prescribing NOCTIVA for patients at increased risk for severe hyponatremia and should ensure that serum sodium concentration is normal before starting or resuming NOCTIVA. The use of NOCTIVA during pregnancy is not recommended and NOCTIVA also should not be used for the treatment of primary nocturnal enuresis in children, as the clinical  trials excluded these populations.

    Case Study and Clinical Takeaways 

    As discussed previously, 61-year-old Michael typifies the experience of nocturnal polyuria in many older men. However, women and younger patients also commonly experience bothersome, clinically significant nocturia. The mental and physical impact of nocturia can especially difficult for younger patients, who often juggle demanding work schedules and parenting or caregiving responsibilities.43,26

    For example, Lisa is a 46-year-old flight attendant with a 5-year history of overactive bladder. She reports that antimuscarinic treatment with solifenacin (started at 5 mg and subsequently increased to 10 mg) has greatly improved her daytime urgency but not her nocturia. She continues to wake every 2 to 2.5 hours at night to void despite drinking only 32 ounces of water per day, avoiding all fluids after 6 PM, limiting caffeine to a single cup of coffee in the morning, and abstaining from alcohol. Lisa also states that her nocturia is causing significant daytime fatigue and difficulty functioning at work. She asks about intranasal desmopressin treatment with NOCTIVA.

    Lisa appears to be a good candidate for NOCTIVA therapy. Her fluid intake and voiding patterns indicate that her nocturia is due to nocturnal polyuria, and she has no contraindications for receiving NOCTIVA such as current hyponatremia, a history of hyponatremia, or pregnancy, urinary retention, estimated glomerular filtration rate [GFR] below 50 mL/min/1.73 m2, polydipsia, primary nocturnal enuresis, syndrome of inappropriate antidiuretic hormone secretion [SIADH], New York Heart Association (NYHA) Class II-IV congestive heart failure, uncontrolled hypertension, or concomitant use of loop diuretics or systemic or inhaled glucocorticoids.79

    NOCTIVA is available in two microdose formulations: 1.66 mcg for patients younger than 65 years who are not at increased risk for hyponatremia, and NOCTIVA 0.83 mcg for patients who are 65 years of age or older or for younger patients at increased risk for hyponatremia.79 After at least 7 days of treatment, the 0.83-mcg dose can be increased to 1.66 mcg if needed, provided that the serum sodium concentration stays within normal range during treatment with the 0.83-mcg dose.

    Based Lisa’s age, history, and nocturia, she and her urologist decide to start NOCTIVA 1.66 mcg. Her serum sodium level is confirmed to be within normal range (141 meq/L) at baseline and she makes an appointment to have it re-measured 7 days and again 1 month after starting NOCTIVA.79 If her serum sodium remains within normal limits, she can continue NOCTIVA 1.66 mcg as long as she agrees to periodic serum sodium monitoring.

    Periodic serum sodium monitoring should be performed more frequently in patients who are 65 years of age and older or at increased risk for hyponatremia. These include patients who are on medications that can increase the risk for hyponatremia, including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, chlorpromazine, opiate analgesics, anti-inflammatory medications, lamotrigine, and carbamapezine. 76,77,79

    Since Lisa is receiving the SSRI sertraline, her urologist advises repeat serum sodium monitoring every 6 months. She also is instructed to have her serum sodium level measured 7 days and 1 month after any increase in her antidepressant dose or if she adds or switches to other medications that can cause hyponatremia. She is given a list of these medications to take home along with a print-out summarizing her treatment instructions.

    Lisa’s urologist informs her that her bottle of NOCTIVA contain 30 days of medication when used once per night, can be stored at room temperature for up to 60 days after opening, and does not need to be re-primed unless she goes more than 3 nights without using it.79 She is instructed to spray NOCTIVA once in each nostril 30 minutes before bedtime and not to double-dose, even if it seems that not much liquid is dispensed when the applicator is pumped.79

    Finally, Lisa is educated to stop using NOCTIVA if she develops a condition that could increase its intranasal absorption, such as respiratory infections or hay fever, or if she develops any condition that might lead to fluid or electrolyte imbalances, such as illnesses that cause vomiting. She should only re-start NOCTIVA after such conditions fully resolve. Lisa returns after 1 month of treatment. Her serum sodium remains within normal limits (137 mEq/L) and she reports that she is now able to sleep 4 hours before waking to void. She reports significant improvements in her mood, energy levels, and productivity.

    Summary

    Nocturia, the most prevalent lower urinary tract symptom among adults of all ages, significantly reduces energy levels, productivity, and quality of life, increases the risk of serious somatic and mental illnesses, and is an independent risk factor for falls, fractures, and mortality. Although nocturnal polyuria is the most common cause of nocturia, the condition is complex and multifactorial and all possible etiologies must be considered to maximize the chances of treatment efficacy. Management should include lifestyle and behavioral modifications, although these can be difficult to sustain and usually are not effective by themselves.

    Medications for overactive bladder and benign prostatic hypertrophy are not approved for the treatment of nocturnal polyuria and are usually ineffective in this context. NOCTIVA, a novel formulation of intranasal desmopressin, is the first FDA-approved treatment for adults with nocturnal polyuria who wake at least twice per night to void. In two randomized, double-blind, placebo-controlled trials, NOCTIVA significantly reduced mean nocturic episodes, increased the likelihood of achieving at least a 50% reduction from baseline in mean nocturic episode, significantly reduced nocturnal urine production, increased the percentage of nights in which patients had one or fewer nocturic episodes, and significantly increased the mean first uninterrupted sleep period. NOCTIVA 1.66 mcg also was associated with significant positive patient-reported improvements of quality of life based on a validated survey tool.

    NOCTIVA showed a tolerable safety profile, with only 1.1% of treated patients in the safety analysis developing serum sodium levels of 125 mmoL per L or less. All these patients were older than 65 years, and two were receiving contraindicated medications in the form of inhaled or systemic corticosteroids. The safe, effective use of NOCTIVA requires appropriate patient selection, education, and monitoring of treatment response. NOCTIVA is available in two desmopressin microdoses (1.66 mcg and 0.83 mcg), enabling physicians to tailor therapy accordingly.

    Published Date: April 16th, 2019
    Written by: Roger R. Dmochowski, MD, MMHC, FACS and Benjamin M. Brucker, MD
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    1. Oriá MOB, Mitchell EM, Vasconcelos CTM, et al. Prevalence of lower urinary tract symptoms and social determinants in primary care users in Brazil. Int Urogynecol J. 2018 Mar 24. doi: 10.1007/s00192-018-3635-1. [Epub ahead of print]
    2. Kowalik CG, Cohn JA, Delpe S, et al. Nocturia: evaluation and current management strategies. Rev Urol. 2018;20(1):1-6.
    3. Wilson JL, Miranda CA, Knepper MA. Vasopressin and the regulation of aquaporin-2. Clin Exp Nephrol. 2013;17(6):751-764.
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    10. Business Wire. NOCDURNA®(desmopressin acetate) Now Approved by U.S. FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria https://www.businesswire.com/news/home/20180621006181/en/NOCDURNA%C2%AE-desmopressin-acetate-Approved-U.S.-FDA-Sublingual Accessed October 24, 2018.
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    Published April 16, 2019
  • Prevention Strategies - Indwelling Urinary Catheters

    Overview  |  Executive Summary
    Summary of Recommendations  |  Appropriate Urinary Catheter Use
    Proper Techniques for Urinary Catheter Insertion  |  Proper Techniques for Urinary Catheter Maintenance
    Quality Improvement Programs  |  Administrative Infrastructure  |  Surveillance  |  Download  |  References

    CAUTI Prevention:

    The 2009 Centers for Disease Control and Prevention (CDC) guidelines for the prevention of catheter-associated urinary tract infections (UTIs) recommends catheter use only for appropriate indications. Catheter use and duration should be minimized in all patients, especially those at higher risk for catheter-associated UTIs (e.g., women, elderly persons, and patients with impaired immunity).

    Catheters should be kept in place only for as long as needed. Indwelling catheters placed in patients undergoing surgery should be removed as soon as possible postoperatively. The use of urinary catheters for treatment of incontinence in patients and nursing home residents should be avoided.
    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    Published January 15, 2013
  • Recurrent Urinary Tract Infection (rUTI) in Women Clinical Care Pathway

    EVALUATION


    Recurrent Urinary Tract Infections (rUTI) is defined as: >2 culture-positive UTIs in 6 months or >3 in one year

    1. Take A History - Document symptoms and signs that characterize rUTI episodes and exclude other disorders that could cause the patient’s symptoms (e.g. bacterial vaginosis, vaginal yeast infection, STIs). Ask about the relationship of UTIs to sexual activity, prolonged bladder holding, and bowel irregularity. Rule out noninfectious pelvic and urinary tract sources of symptoms (e.g. overactive bladder, radiation cystitis, bladder pain syndrome, vulvodynia, pelvic organ prolapse, urinary retention/poor bladder emptying, and neurogenic bladder).

    Genito-urinary history:  Evaluate for complicating factors including pediatric/congenital urologic conditions (e.g., vesicoureteral reflux, megaureter), nephrolithiasis, flank pain, incomplete bladder emptying, prior bladder/pelvic surgery (especially use of mesh material), vaginal pain, cysts or lesions in the vagina, antiestrogen use, pelvic malignancy, absorbent pad use, fecal incontinence, immunosuppression, and neurologic disease.

    Review prior urine culture resultsto confirm rUTI diagnosis with two or more positive cultures in 6 months or 3 or more in one year.  

    2. Perform Physical Exam to include a pelvic examination - Assess for hygiene and fecal contamination, look for urethral diverticulum, vaginal discharge and/or yeast, vaginal cysts, atrophic vaginitis, and pelvic organ prolapse. If prior mesh or pelvic surgery, consider cystoscopy if a vaginal cyst or periurethral fluctuance (pseudo-urethral abscess formation) order pelvic MRI with coil.

    3. Collect Urine Specimen for Testing - Send urine specimen for urinalysis (UA) if symptoms suggestive of UTI.  If positive, send the specimen for urine culture and sensitivities.  If microscopic hematuria in the absence of infection work-up alongside initial therapy. If sterile pyuria, rule out STIs and urinary TB (AFB’s). If asymptomatic bacteriuria, do not treat.  Assess for bacterial persistence, if present considers cross-sectional imaging (retroperitoneal ultrasound) and +/- cystoscopy.

    4. Perform ultrasound (bladder scan) US PVR (immediately after voiding) - if >150 cc (on 2 separate occasions) and monitor. Consider intermittent self-catheterization if no other source for infection identified and 1st line suppression fails.

    TREATMENT

    1st Line Therapy (Behavioral/Lifestyle Modifications) and UTI Prevention Measures

    • Diabetic patients: Control blood glucose and avoid glucosuria
    • Fluid intake: Maintain adequate hydration (Hooten recommended drinking 1.5 L of water daily along with the suggestion to start a 500 mL bottle of water at the beginning of every meal and fully drink it before the next meal).
    • Dietary Changes: Cranberry use in all its forms is not supported by current evidence; however, little harm is associated with its use.
    • Probiotic: Use of either oral or intravaginal probiotics to restore the natural vaginal microbiota (Lactobacillus spp. colonies) seems to be a promising approach to reducing antibiotic consumption and to decreasing antimicrobial resistance.  Lactobacilli may especially be useful for women with histories of recurrent, complicated UTIs or on prolonged antibiotic use.   Dietary sources of probiotics may be helpful, these include probiotic yogurt (such as Activia), Greek yogurt, kefir and kombucha juice.
    • Voiding habits: Avoid prolonged holding of urine, avoid delaying urination (peeing)
    • Hygiene: Avoid disruption of normal vaginal flora with spermicides and/ or harsh cleansers. Avoid soaking in tubs, hot tubs and in baths. 
    • Sex: Void before and after intercourse and avoid sequential anal and vaginal intercourse
    • Bowel Regimen – If diarrhea and/or fecal incontinence are present start loperimide. If mild-moderate constipationis present begin bowel regimen including increasing dietary fiber, stool softener, and/or miralax.  If moderate-severe constipation is present begin bowel regimen (as above) if not on one and consider referral to Primary Care/GI if refractory.
    • Persisting irritative bladder symptoms: Many women experience irritative bladder symptoms of pressure or discomfort, bladder urgency, burning when peeing after adequate antibiotic treatment.  These symptoms can mimic UTI symptoms and many women are erroneously prescribed another antibiotic but do not exhibit a relief of these irritative symptoms.  Consider one of the following treatment regimens:
        • Prescribe: Urelle 81 mg tab, 4 times a day (evenly spaced).  Take each dose with a full glass of water (8 ounces/240 mL). Can take with food if GI upset occurs.
      • Over-the-counter medications:
              • Azo-Pyridium (phenazopyridine) 100 mg or Uricalm MAX 99.5 mg (phenazopyridine). These are not prescription medications but can be found at most pharmacies or drug stores.
              • NSAID (Motrin, Aleve) as the symptoms of UTIs are mostly connected to the infammatory reaction of the urinary tract due to a signifcant increase in urinary prostaglandin production, because the onset and duration of clinical symptoms of UTI seem to be strongly connected to prostaglandin levels. Since NSAIDs can inhibit the biosynthesis of prostaglandins, they can be useful in alleviating the symptoms of UTI.
    Persistence Acute treatment for breakthrough UTI should start with obtaining a urine culture.  If initiation of empiric antibiotics is requested use prior culture data to choose among first line treatments while culture is pending. Consider antibiotic resistance patterns in each patient as well as in the local community and consider patient allergies, side effects and cost.  Clinical practice guidelines recommend utilization of short duration nitrofurantoin (100 mg BID x 5 days), trimethoprim-sulfamethoxazole (100mg/800mg BID x 3 days), or fosfomycin (1 packet x 1 dose).  

    bladder_health_coe.png
     

    Follow up in 6 months with the maintenance of records of all symptomatic episodes, antibiotic use, UA, and urine culture results. If 2 or more infections in 6 months move to 2nd line therapy.

    2nd Line Therapy (Medications)

    Review and Reinforce 1st line Therapy +

    • In Postmenopausal Women with rUTIs:
      • Initiate transvaginal (topical) estrogen and lactobacillus containing probiotics daily.  Vaginal estrogen can be prescribed as Estrace cream 1 gram or Premarin cream 0.5 grams, Vagifem (Yuvafem) 10 mcg tablets (all can be used daily for 2 weeks then twice weekly), Estring, or compounded estrogen for approximately $50 a tube.
        • Estrace cream comes with 1 applicator that always has to be cleaned. Go on the manufacturer's website (www.estracecream.com), click “Request Applicators” and get 24 individually wrapped applicators at no cost, every 3 months.
      • If already on these measures or they are contraindicated or ineffective after 6 months, add methenamine hippurate (Hiprex) 1 gram twice daily plus vitamin C 500 mg twice daily.  
        • Avoid Vitamin C if history of kidney stones
        • If renal insufficiency/decreased GFR, dose methenamine hippurate accordingly
      • In severe cases, consider combined initial therapy with vaginal estrogen, probiotics, methenamine hippurate and vitamin C.
        • An alternative to methenamine hippurate is d-Mannose 500- 750 mg twice/day, a monosaccharide that can be rapidly absorbed and excreted by the urinary tract and can prevent the adhesion of type 1 bacterial fimbriae (bacterial virulence factor, usually caused by E. coli) promoting UTI to the uroepithelium

     

    • In Premenopausal Women with rUTIs
      • With Post-Coital rUTIs:
        • Initiate a single low dose prophylactic antibiotic* within 2 hours of sexual activity for 6-12 months duration OR
        • Has already tried post-coital antibiotics, or has intercourse more than twice per week initiate methenamine hippurate 1 gram twice daily, vitamin C 500 mg twice daily and lactobacillus containing probiotics daily or alternative to methenamine hippurate is d-Mannose 500- 750 mg twice/day.
      • With rUTI unrelated to sexual activity:
        • Consider daily low dose prophylactic antibiotic* for 6-12 months’ duration OR
        • Have already tried daily antibiotics, initiate methenamine hippurate 1 gram twice daily, vitamin C 500 mg twice daily and lactobacillus containing probiotics daily or alternative to methenamine hippurate is d-Mannose 500- 750 mg twice/day
    *Prophylactic antibiotic choice should take into account a patient’s prior organism identification and susceptibility profile, drug allergies, and antibiotic stewardship. Nitrofurantoin 50 mg, trimethoprim-sulfamethoxazole 40/200 mg, trimethoprim 100 mg are preferred over fluoroquinolones and/or cephalosporins.

    Follow up in 6 months with the maintenance of records of all symptomatic episodes, antibiotic use, UA, and urine culture results. If refractory; consider an evaluation with cross sectional imaging +/- cystoscopy. In refractory patients, alternative prophylactic antibiotics can be tried. In severe refractory cases in patients on intermittent catheterization, intravesical gentamycin can be considered.

    figure-1-recurrent-UTI-pathway2x_1.jpg
    Published Date: September 26th, 2019
    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: 1. American Urological Association, the Canadian Urological Association and the Society of Urodynamics Female Pelvic Medicine and Urogenital Reconstruction.   Recurrent uncomplicated UTIs in women. 
    2. Hooton TM, Vecchio M, Iroz A, Tack I, Dornic Q, Seksek I, Lotan Y. Effect of increased daily water intake in premenopausal women with recurrent urinary tract infections: A randomized clinical trial. JAMA Intern Med. 2018 Nov 1;178(11):1509-1515. doi: 10.1001/jamainternmed.2018.4204
    3. Nicolle et al., Practice Guideline for the Management of Asymptomatic Bacteriuria: 2019 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2019 Mar 21. pii: ciy1121. doi: 10.1093/cid/ciy1121). 
    4. Smith AL, Brown J, Wyman JF, Berry A, Newman DK, Stapleton AE. Treatment and prevention of recurrent lower urinary tract infections in women: A rapid review with practice recommendations. J Urol. 2018 Dec;200(6):1174-1191. doi: 10.1016/j.juro.2018.04.088). 
    5. Wawrysiuk S, Naber K, Rechberger T, Miotla P. Prevention and treatment of uncomplicated lower urinary tract infections in the era of increasing antimicrobial resistance-non-antibiotic approaches: a systemic review. Arch Gynecol Obstet. 2019 Jul 26. doi: 10.1007/s00404-019-05256-
    Published September 27, 2019
  • Sleep Quality and Daytime Sleepiness Among Women With Urgency Predominant Urinary Incontinence.

    The objective of this study was to examine the strength and direction of the association between urinary symptoms and both poor quality sleep and daytime sleepiness among women with urgency urinary incontinence.

    Published January 7, 2018
  • SUFU 2019: An Update on Nocturia - What's Keeping You Up at Night?

    Miami, FL (UroToday.com) Dr. Jeffrey Weiss provided an update of the management of nocturia. Patients are oftentimes asked to fill out a 24-hour voiding diary but compliance in completing them is sometimes very difficult to obtain. First and foremost each patient should be assessed for other comorbidities. It is also important to differentiate nocturnal polyuria defined as 33% of total urine over 24 hours or urine production>90ml/hour. There are many causes of nocturia and lower urinary tract symptoms.
    Published March 2, 2019
  • SUFU 2019: The Impact of the New Guidelines on the Management of BPH in 2019

    Miami, FL (UroToday.com) Dr. Foster leads the audience through the AUA BPH Guidelines briefly emphasizing the new changes /updates that will be seen in the new updated BPH guidelines.  Why talk about new guidelines now? Several BPH therapies have emerged and will be getting incorporated into the guidelines.  Aquablation, urethral prostatic lift, prostate artery embolization, water thermal therapy, etc. Medical management is also being looked at and will be updated in the new guidelines.
    Published February 28, 2019
  • Techniques and Procedures for Use - Indwelling Catheters

    I. Appropriate Urinary Catheter Use

    A. Insert catheters only for appropriate indications (see Table 2 for guidance), and leave in place only as long as needed. (Category IB) (Key Questions 1B and 2C)

      1. Minimize urinary catheter use and duration of use in all patients, particularly those at higher risk for CAUTI or mortality from catheterization such as women, the elderly, and patients with impaired immunity. (Category IB) (Key Questions 1B and 1C)
      2. Avoid use of urinary catheters in patients and nursing home residents for management of incontinence. (Category IB) (Key Question 1A)
        1. Further research is needed on periodic (e.g., nighttime) use of external catheters (e.g., condom catheters) in incontinent patients or residents and the use of catheters to prevent skin breakdown. (No recommendation/unresolved issue) (Key Question 1A)
      1. Use urinary catheters in operative patients only as necessary, rather than routinely. (Category IB) (Key Question 1A)
      2. For operative patients who have an indication for an indwelling catheter, remove the catheter as soon as possible postoperatively, preferably within 24 hours, unless there are appropriate indications for continued use. (Category IB) (Key Questions 2A and 2C)
    Table 2. A. Examples of Appropriate Indications for Indwelling Urethral Catheter Use 1-4
    Patient has acute urinary retention or bladder outlet obstruction
    Need for accurate measurements of urinary output in critically ill patients

    Perioperative use for selected surgical procedures:

    • Patients undergoing urologic surgery or other surgery on contiguous structures of the genitourinary tract
    • Anticipated prolonged duration of surgery (catheters inserted for this reason should be removed in PACU)
    • Patients anticipated to receive large-volume infusions or diuretics during surgery
    • Need for intraoperative monitoring of urinary output
    To assist in healing of open sacral or perineal wounds in incontinent patients
    Patient requires prolonged immobilization (e.g., potentially unstable thoracic or lumbar spine, multiple traumatic injuries such as pelvic fractures)
    To improve comfort for end of life care if needed
     
    B. Examples of Inappropriate Uses of Indwelling Catheters
    As a substitute for nursing care of the patient or resident with incontinenceAs a means of obtaining urine for culture or other diagnostic tests when the patient can voluntarily void
    For prolonged postoperative duration without appropriate indications (e.g., structural repair of urethra or contiguous structures, prolonged effect of epidural anaesthesia, etc.).
    Note: These indications are based primarily on expert consensus
     
    B. Consider using alternatives to indwelling urethral catheterization in selected patients when appropriate.
      1. Consider using external catheters as an alternative to indwelling urethral catheters in cooperative male patients without urinary retention or bladder outlet obstruction. (Category II) (Key Question 2A)
      2. Consider alternatives to chronic indwelling catheters, such as intermittent catheterization, in spinal cord injury patients. (Category II) (Key Question 1A)
      3. Intermittent catheterization is preferable to indwelling urethral or suprapubic catheters in patients with bladder emptying dysfunction. (Category II) (Key Question 2A)
      4. Consider intermittent catheterization in children with myelomeningocele and neurogenic bladder to reduce the risk of urinary tract deterioration. (Category II) (Key Question 1A)
      5. Further research is needed on the benefit of using a urethral stent as an alternative to an indwelling catheter in selected patients with bladder outlet obstruction. (No recommendation/unresolved issue) (Key Question 1A)
      6. Further research is needed on the risks and benefits of suprapubic catheters as an alternative to indwelling urethral catheters in selected patients requiring short- or long-term catheterization, particularly with respect to complications related to catheter insertion or the catheter site. (No recommendation/unresolved issue) (Key Question 1A)

    II. Proper Techniques for Urinary Catheter Insertion

    1. Perform hand hygiene immediately before and after insertion or any manipulation of the catheter device or site. (Category IB) (Key Question 2D)
    2. Ensure that only properly trained persons (e.g., hospital personnel, family members, or patients themselves) who know the correct technique of aseptic catheter insertion and maintenance are given this responsibility. (Category IB) (Key Question 1B)
    3. In the acute care hospital setting, insert urinary catheters using aseptic technique and sterile equipment. (Category IB
      1. Use sterile gloves, drape, sponges, an appropriate antiseptic or sterile solution for periurethral cleaning, and a single-use packet of lubricant jelly for insertion. (Category IB)
      2. Routine use of antiseptic lubricants is not necessary. (Category II) (Key Question 2C)
      3. Further research is needed on the use of antiseptic solutions vs. sterile water or saline for periurethral cleaning prior to catheter insertion. (No recommendation/unresolved issue) (Key Question 2C)
    4. In the non-acute care setting, clean (i.e., non-sterile) technique for intermittent catheterization is an acceptable and more practical alternative to sterile technique for patients requiring chronic intermittent catheterization.(Category IA) (Key Question 2A) 
      1. Further research is needed on optimal cleaning and storage methods for catheters used for clean intermittent catheterization. (No recommendation/unresolved issue) (Key Question 2C)
    5. Properly secure indwelling catheters after insertion to prevent movement and urethral traction. (Category IB)
    6. Unless otherwise clinically indicated, consider using the smallest bore catheter possible, consistent with good drainage, to minimize bladder neck and urethral trauma. (Category II)
    7. If intermittent catheterization is used, perform it at regular intervals to prevent bladder overdistension. (Category IB) (Key Question 2A)
    8. Consider using a portable ultrasound device to assess urine volume in patients undergoing intermittent catheterization to assess urine volume and reduce unnecessary catheter insertions. (Category II) (Key Question 2C) 
      1. If ultrasound bladder scanners are used, ensure that indications for use are clearly stated, nursing staff are trained in their use, and equipment is adequately cleaned and disinfected in between patients. (Category IB)

    III. Proper Techniques for Urinary Catheter Maintenance

    1. Following aseptic insertion of the urinary catheter, maintain a closed drainage system. (Category IB) (Key Question 1B and 2B) 
      1. If breaks in aseptic technique, disconnection, or leakage occur, replace the catheter and collecting system using aseptic technique and sterile equipment. (Category IB)
      2. Consider using urinary catheter systems with preconnected, sealed catheter-tubing junctions. (Category II) (Key Question 2B)
    2. Maintain unobstructed urine flow. (Category IB) (Key Questions 1B and 2D)
      1. Keep the catheter and collecting tube free from kinking. (Category IB)
      2. Keep the collecting bag below the level of the bladder at all times. Do not rest the bag on the floor. (Category IB)
      3. Empty the collecting bag regularly using a separate, clean collecting container for each patient; avoid splashing, and prevent contact of the drainage spigot with the nonsterile collecting container. (Category IB)
    3. Use Standard Precautions, including the use of gloves and gown as appropriate, during any manipulation of the catheter or collecting system. (Category IB)
    4. Complex urinary drainage systems (utilizing mechanisms for reducing bacterial entry such as antiseptic-release cartridges in the drain port) are not necessary for routine use. (Category II) (Key Question 2B)
    5. Changing indwelling catheters or drainage bags at routine, fixed intervals is not recommended. Rather, it is suggested to change catheters and drainage bags based on clinical indications such as infection, obstruction, or when the closed system is compromised. (Category II) (Key Question 2C)
    6. Unless clinical indications exist (e.g., in patients with bacteriuria upon catheter removal post urologic surgery), do not use systemic antimicrobials routinely to prevent CAUTI in patients requiring either short or long-term catheterization. (Category IB) (Key Question 2C)
      1. Further research is needed on the use of urinary antiseptics (e.g., methenamine) to prevent UTI in patients requiring short-term catheterization. (No recommendation/unresolved issue) (Key Question 2C)
    7. Do not clean the periurethral area with antiseptics to prevent CAUTI while the catheter is in place. Routine hygiene (e.g., cleansing of the meatal surface during daily bathing or showering) is appropriate. (Category IB) (Key Question 2C)
    8. Unless obstruction is anticipated (e.g., as might occur with bleeding after prostatic or bladder surgery) bladder irrigation is not recommended. (Category II) (Key Question 2C)
      1. If obstruction is anticipated, closed continuous irrigation is suggested to prevent obstruction. (Category II)
    9. Routine irrigation of the bladder with antimicrobials is not recommended. (Category II) (Key Question 2C)
    10. Routine instillation of antiseptic or antimicrobial solutions into urinary drainage bags is not recommended. (Category II) (Key Question 2C)
    11. Clamping indwelling catheters prior to removal is not necessary. (Category II) (Key Question 2C)
    12. Further research is needed on the use of bacterial interference (i.e., bladder inoculation with a nonpathogenic bacterial strain) to prevent UTI in patients requiring chronic urinary catheterization. (No recommendation/unresolved issue) (Key Question 2C)

    Catheter Materials

    1. If the CAUTI rate is not decreasing after implementing a comprehensive strategy to reduce rates of CAUTI, consider using antimicrobial/antiseptic-impregnated catheters. The comprehensive strategy should include, at a minimum, the high priority recommendations for urinary catheter use, aseptic insertion, and maintenance (see Section III. Implementation and Audit). (Category IB) (Key Question 2B)
      1. Further research is needed on the effect of antimicrobial/antiseptic-impregnated catheters in reducing the risk of symptomatic UTI, their inclusion among the primary interventions, and the patient populations most likely to benefit from these catheters. (No recommendation/unresolved issue) (Key Question 2B)
    2. Hydrophilic catheters might be preferable to standard catheters for patients requiring intermittent catheterization. (Category II) (Key Question 2B)
    3. Silicone might be preferable to other catheter materials to reduce the risk of encrustation in long-term catheterized patients who have frequent obstruction. (Category II) (Key Question 3)
    4. Further research is needed to clarify the benefit of catheter valves in reducing the risk of CAUTI and other urinary complications. (No recommendation/unresolved issue) (Key Question 2B)

    Management of Obstruction

    1. If obstruction occurs and it is likely that the catheter material is contributing to obstruction, change the catheter. (Category IB)
    2. Further research is needed on the benefit of irrigating the catheter with acidifying solutions or use of oral urease inhibitors in long-term catheterized patients who have frequent catheter obstruction. (No recommendation/unresolved issue) (Key Question 3)
    3. Further research is needed on the use of a portable ultrasound device to evaluate for obstruction in patients with indwelling catheters and low urine output. (No recommendation/unresolved issue) (Key Question 2C)
    4. Further research is needed on the use of methenamine to prevent encrustation in patients requiring chronic indwelling catheters who are at high risk for obstruction. (No recommendation/unresolved issue) (Key Question 2C)

    Specimen Collection

    1. Obtain urine samples aseptically. (Category IB)
      1. If a small volume of fresh urine is needed for examination (i.e., urinalysis or culture), aspirate the urine from the needleless sampling port with a sterile syringe/cannula adapter after cleansing the port with a disinfectant. (Category IB)
      2. Obtain large volumes of urine for special analyses (not culture) aseptically from the drainage bag. (Category IB

    Reference:

    [Guideline] Gould, C. V., C. A. Umscheid, et al. (2010). "Guideline for prevention of catheter-associated urinary tract infections 2009." Infect Control Hosp Epidemiol 31(4): 319-326.
    [Guideline] Hooton, T. M., S. F. Bradley, et al. (2010). "Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines fInfectious Diseases Society of America." Clin Infect Dis 50(5) :625-663.

    Published Date: January 14th, 2013

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: I. Appropriate Urinary Catheter Use
    A. Insert catheters only for appropriate indications (see Table 2 for guidance), and leave in place only as long as needed. (Category IB) (Key Questions 1B and 2C)


     
    Published January 15, 2013
  • Techniques and Procedures for Use - Intermittent Catheters

    Techniques & Procedures for Use

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: 1. Beauchemin, Lisa, Diane K. Newman, Maureen Le Danseur, Angela Jackson, and Mike Ritmiller. "Best practices for clean intermittent catheterization." Nursing2019 48, no. 9 (2018): 49-54.

    2. Goetz, Lance L., Linda Droste, Adam P. Klausner, and Diane K. Newman. "Catheters used for intermittent catheterization." In Clinical Application of Urologic Catheters, Devices and Products, pp. 47-77. Springer, Cham, 2018.

    3. Lapides, Jack, Ananias C. Diokno, Sherman J. Silber, and Bette S. Lowe. "Clean, intermittent self-catheterization in the treatment of urinary tract disease." The Journal of urology 107, no. 3 (1972): 458-461.

    4. Lindehall, B., K. Abrahamsson, U. Jodal, I. Olsson, and U. Sillén. "Complications of clean intermittent catheterization in young females with myelomeningocele: 10 to 19 years of followup." The Journal of urology 178, no. 3 (2007): 1053-1055.

    5. Moore, Katherine N., Jean Burt, and Donald C. Voaklander. "Itermittent catheterization in the rehabilitation setting: a comparison of clean and sterile technique." Clinical rehabilitation 20, no. 6 (2006): 461-468.

    6.Moore, Katherine N., Mandy Fader, and Kathryn Getliffe. "Long‐term bladder management by intermittent catheterisation in adults and children." Cochrane Database of Systematic Reviews 4 (2007).
    Published February 5, 2020
  • The Relationship Between Uterosacral Ligament Laxity, OAB , Chronic Pain and Bowel Dysfunction - Expert Commentary

    This commentary outlines the anatomical basis for surgical cure of OAB as reported by Liedl et al., in a multicentre study (n=611) in the Central European Journal of Urology1. This is the first substantive study aimed to challenge the Integral Theory’s predictions that OAB and other pelvic symptoms are mainly caused by loose suspensory ligaments2, are a consequence of deficient collagen/elastin within them, and are potentially curable surgically, Table1, by use of a polypropylene tape to create a collagenous neoligament 3. The first application of this neoligament methodology 3 was reinforcement of damaged pubourethral ligaments 4 as part of the midurethral sling operation, ‘TVT’ 4 for cure of urinary stress incontinence.
    Published November 14, 2018
  • Transperineal Urethroplasty with Gracilis Muscle Interposition - Expert Commentary

    Pelvic fracture urethral defects (PFUDs) occur in around 10% of patients with pelvic fractures. PFUDs can sometimes be associated with urethrorectal fistulas and these have proven to be extremely difficult to operate on and repair. To date, there have not been any standardized approach to the treatment of complex PFUDs with associated URFs. Until now, surgeons have typically used various surgical approaches to repair these complex PFUDs such as utilizing various vascularized tissue flaps to interposition.
    Published September 18, 2017
  • Types and Materials – External Urine Collection Devices

    The shape and material of external urine collection devices (EUCD) have changed over the past 20 years. Historically, most EUCDs were made from latex that allowed for flexibility but also increased the risk of an allergic reaction. Latex-based sheath devices are still available but more recent ones are constructed from non-allergenic silicone. Most EUCDs are open at the distal end (tip) allowing urine to drain through attached tubing connected to a drainage bag. 

    figure-1-materials2x_1.jpg

    There are two broad categories, those that are single-use disposable products (in-place for only one to two days), and those that are reusable for multiple times.

    If the EUCD has adhesive, prior to its application, the skin should be cleansed and pubic hair at the base of the penis in men and the perineum in women should be removed. The hair should be trimmed, not shaved, because shaving causes more irritation. The EUCD can be removed by loosening the adhesive with a warm, wet cloth. 

    We are categorizing the types of EUCDs as follows:

    table 1 external urine collection devices2x 1

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN, Adjunct Professor of Urology in Surgery, Research Investigator Senior, Perelman School of Medicine, Co-Director, Penn Center for Continence and Pelvic Health, Division of Urology, University of Pennsylvania, Philadelphia, Pennsylvania

    Published Date: April 17th, 2020

    Written by: Diane K. Newman, DNP, ANP-BC, FAAN
    References: 1. Beeson, Terrie, and Carmen Davis. "Urinary management with an external female collection device." Journal of Wound, Ostomy, and Continence Nursing 45, no. 2 (2018): 187.
    2. Cottenden, Alan, D. Z. Bliss, B. Buckley, M. Fader, C. Gartley, D. Hayder, J. Ostaszkiewicz, and M. Wilde. "Management using continence products." Incontinence (2013): 1651-1786.
    3. Doherty, Willie. "The InCare Retracted Penis Pouch: an alternative for incontinent men." British journal of nursing 11, no. 11 (2002): 781-784.
    4. Gray, Mikel, Claudia Skinner, and Wendy Kaler. "External collection devices as an alternative to the indwelling urinary catheter: evidence-based review and expert clinical panel deliberations." Journal of Wound, Ostomy, and Continence Nursing 43, no. 3 (2016): 301.
    5. Newman, Diane K., and Alan J. Wein. "External Catheter Collection Systems." In Clinical Application of Urologic Catheters, Devices and Products, pp. 79-103. Springer, Cham, 2018.
    6. Newman, D. K. "Devices, products, catheters, and catheter-associated urinary tract infections." Core curriculum for urologic nursing. 1st ed. Pitman: Society of Urologic Nurses and Associates, Inc (2017): 439-66.
    7. Newman, D. K., and A. J. Wein. "Managing and treating urinary incontinence. 2009 Baltimore."
    8. Newman, Diane K. "Internal and external urinary catheters: a primer for clinical practice." Ostomy/wound management 54, no. 12 (2008): 18-35.
    9. Newman, Diane K. "Incontinence products and devices for the elderly." Urologic nursing 24, no. 4 (2004): 316-333.
    10. Newman, Diane K., Mandy Fader, and Donna Z. Bliss. "Managing incontinence using technology, devices, and products: directions for research." Nursing Research 53, no. 6S (2004): S42-S48.
    11. Newman, D. K. "The use of devices and products." American Journal of Nursing 3 (2003): 50-51.
    12. Pomfret, I. "Penile sheaths: a guide to selection and fitting." Journal of Community Nursing 20, no. 11 (2006): 14.
    13. Smart, Clare. "Male urinary incontinence and the urinary sheath." British Journal of Nursing 23, no. Sup9 (2014): S20-S25.
    14. Wells, Mandy. "Managing urinary incontinence with BioDerm® external continence device." British Journal of Nursing 17, no. Sup4 (2008): S24-S29.
    15. Vaidyanathan, S., B. M. Soni, G. Singh, P. Sett, E. Brown, and S. Markey. "Possible use of BioDerm External Continence Device in selected, adult, male spinal cord injury patients." Spinal cord 43, no. 4 (2005): 260-261.
    Published April 17, 2020
  • UTI – Is Traditional Culture Testing Obsolete?

    Published in Everyday Urology - Oncology Insights: Volume 5, Issue 1
    Published Date: March 2020

    Urinary tract infections are the most common type of bacterial infection,1 accounting for at least 11 million physician office visits, 2 to 3 million emergency department visits, 400,000 hospitalizations, and approximately $2.3 billion in healthcare costs annually in the United States.2,3,4,5
    Published April 16, 2020
  • Velicept Therapeutics Announces Positive Top-Line Phase 2b Results for Solabegron in the Treatment of Overactive Bladder (OAB)

    San Francisco, CA USA (UroToday.com) -- Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced that its next generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a Phase 2b study in patients with overactive bladder (OAB). In the study, twice-daily administration of solabegron demonstrated a statistically significant improvement compared to placebo at week 12, as measured by the mean change in number of micturitions per day, the study’s primary endpoint. Solabegron also demonstrated statistical significance across multiple secondary endpoints including percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes.
    Published March 28, 2019
  • Velicept Therapeutics Initiates First of Two Phase 2b Dose-Ranging Studies of Solabegron in Patients with Overactive Bladder; Finalizes Novel, Once Daily Formulation; and Receives U.S. Patent Covering OAB

    Truckee, CA (UroToday.com) Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced the initiation of the first of two Phase 2b clinical studies. The first study (VEL2002) will evaluate two doses of solabegron dosed twice daily in patients with overactive bladder (OAB). The primary objective of the study is to evaluate the mean change in number of micturitions per day as measured by patients in an e-diary.
    Published March 19, 2018