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Bladder Health

Habits That Can Affect Your Bladder

Common Bladder Irritants Found in Foods and Drinks

Certain foods, liquids and beverages, medications and even herbs can “trigger” your bladder symptoms. Their effect on the bladder is not always understood and the same food or liquid may affect different people and their bladders in different ways. Check the lists found here to see if any of them are adding to your symptoms. If you find one, stop them for a few days to see if your bladder symptoms improve. Then introduce it back and see if you notice any changes.

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.

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.

How to Do Pelvic Floor Muscle Exercises

WHAT ARE THE PELVIC FLOOR MUSCLES?
Your pelvic floor muscles provide support to your bladder, and rectum and, in women, the vagina and the uterus. These muscles are like a sling or hammock in the bottom of your pelvis which is why they are called pelvic floor muscles. If they weaken or are damaged, they do not support pelvic organs and may cause bladder control problems. Keeping the muscles strong by training them, can help prevent urine leakage. You can make these muscles stronger by doing exercises (often called Kegel exercises).

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.

Controlling Your Bladder Urges With Bladder Training

Usually, the bladder can hold urine for 4 to 5 hours, then you feel the urge to pee (urinate) and you should be able to walk to the bathroom. But some people will have an overactive bladder and feel a sudden urge to pee that comes on quickly, they may have that “gotta-go” sensation. This is called bladder urgency.

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

April 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.

Overactive Bladder (OAB) and Urinary Incontinence Clinical Care Pathway

Overactive bladder (OAB) is a symptom complex of lower urinary tract symptoms of urgency, frequency with or without urinary incontinence. It is prevalent in both men and women (10.8% and 12.8% respectively). According to Irwin and colleagues (2006), women have a higher rate (13.1% vs 5.4%) of urinary incontinence (urgency, stress, or mixed), are more likely (19% vs 12%) to report frequency of more than eight times per day, and are more bothered by urinary frequency than men (66% vs 46%).

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 results to 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 loperamide. If mild-moderate constipation is 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 inflammatory reaction of the urinary tract due to a significant 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-

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.

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 NOCTIVATM therapy 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).14 Because 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. 14,60 Persons 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, 4,11,12 Derangements 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.29,25 Medications 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.54 The 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.38 Compared 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.75 Finally, 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. 1 These 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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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

April 2020

Written by: Diane K. Newman, DNP, ANP-BC, FAAN
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