LAS VEGAS, NV USA (UroToday.com) - Dr. Deborah Lightner began by stating that she would be presenting the guidelines for “Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults,” and she pointed out that these are AUA/SUFU guidelines but the majority of the panel members and the reviewers are well-recognized SUFU members. She continued by thanking the panel members and the reviewers for their hard work on the guidelines.
The purpose of these guidelines is to provide a clinical framework for the diagnosis and treatment of non-neurogenic OAB. Dr. Lightner emphasized that the guidelines are a clinical framework, not a textbook or “cookbook” on how to diagnose and treat OAB. The main source for evidence supporting these guidelines was extracted from AHRQ (Agency for Healthcare Research and Quality) Evidence Report #187, which contained data from published studies, through 2008, related to OAB in women. This report searched PubMed, MEDLINE®, EMBASE, and CINAHL for relevant clinical studies. An additional search for relevant studies published between October 2008 and December 2011 was conducted by the AUA. This search added studies including males, symptoms like nocturia, and treatments such as neuromodulation, sacral neuromodulation (SNS), peripheral tibial nerve stimulation (PTNS), and intravesical onabotulinumtoxinA. All together, the searches resulted in 151 articles after inclusion/exclusion criteria were applied, and these 151 articles were then ranked for their evidence strength. Dr. Lightner stressed that we can expect evolution of these guidelines because the search of studies ended in 2011 and there have been new developments in the OAB field since then; this is simply the nature of guidelines – they evolve. She continued to point out that the guidelines cannot be perfect but they can be “state of the art.”
The methodology for rating of evidence strength followed the AUA categorization of Evidence Strength:
- A – Well-conducted randomized controlled trials (RCTs) or exceptionally strong observational studies
- B – RCTs with some weakness or strong observational studies
- C – observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data
The Evidence Strength is linked to type of statement:
- Standard
- Directive Statement
- Level of evidence A or B
- Benefits are > or < than the risks/burdens
- Recommendation
- Directive Statement
- Level of evidence C
- Benefits are > or < than the risks/burdens
- Option
- Non-directive Statement
- Level of evidence A, B or C
- Benefits are = to the risks
In addition, there are a couple of statements that can be made when there is insufficient evidence in the literature. These can be based on:
- Clinical Principle – a statement of clinical care that is widely agreed on by urologists or other clinicians for which there may or may not be evidence in the literature
- Expert Opinion – a statement, achieved by consensus of the panel, that is based on members’ clinical training, experience, knowledge, and judgment for which there is no evidence
In this case, the review of articles related to diagnosis and treatment of non-neurogenic OAB did not include enough articles to address OAB diagnosis in clinical practice, from an evidence standpoint. Therefore, the diagnosis portion of the diagnosis and treatment algorithm is provided as either Clinical Principle or Expert Opinion. When it comes to treatment of OAB, the 151 articles contained enough evidence to create the basis for the treatment portion of the algorithm.
There are 22 statements in the OAB guidelines but only three meet the criteria to be classified as “Standard.” The rest of the statements are classified as follows:
- 3 recommendations
- 5 options
- 8 clinical principles
- 3 expert opinions
Five of the 22 guideline statements (#1-5) address the clinical framework for diagnosis of OAB while 16 statements address the clinical framework for treatment of OAB (#6-21) and the last statement refers to follow-up after treatment (#22).
The 16 statements that address treatment can be further divided into sub-groups:
- First-Line Treatments: #6-7
- Second-Line Treatments: #8-16
- Third-Line Treatments:
- FDA-Approved: #17-18
- Non-FDA-Approved: #19
- Additional Treatments: #20-21
These OAB guidelines are written for all practitioners and Dr. Lightner pointed out a few examples of guideline statements the panel wants all practitioners to pay extra attention to when diagnosing and treating OAB.
The panel wants to make sure that all practitioners at least perform a physical exam and urinalysis, as per statement #1:
| “The clinician should engage in a diagnostic process to document symptoms and signs that characterize OAB and exclude other disorders that could be the cause of the patient’s symptoms; the minimum requirements for this process are a careful history, physical exam, and urinalysis.” Clinical Principle |
The panel does not want “over use” of expensive diagnostics in the initial work-up of the uncomplicated patient, as per statement #3:
| “Urodynamics, cystoscopy, and diagnostic renal and bladder ultrasound should not be used in the initial workup of the uncomplicated patient.” Clinical Principle |
Dr. Lightner highlighted the three Standard statements to make some points about first- and second-line treatment, as expressed in statements #6, #8 and #9:
|
“Clinicians should offer behavioral therapies (e.g., bladder training, bladder control strategies, pelvic floor muscle training, fluid management) as first line therapy to all patients with OAB.” Standard (Evidence Strength Grade B) “Clinicians should offer oral anti-muscarinics including darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, or trospium (listed in alphabetical order; no hierarchy is implied) as second-line therapy.” Standard (Evidence Strength Grade B) “If an immediate release (IR) and an extended release (ER) formulation are available, then ER formulations should preferentially be prescribed over IR formulations because of lower rates of dry mouth.” Standard (Evidence Strength Grade B) |
As an example of the evolution in OAB treatment, Dr. Lightner mentioned statement #10 and pointed out that transdermal oxybutynin is now available as OTC treatment:
| “Transdermal (TDS) oxybutynin (patch or gel) may be offered.” Recommendation (Evidence Strength Grade C) |
Statement #15 addresses the use of anti-muscarinics in frail elderly and Dr. Lightner referred to the “American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults,” where medications with risks that may outweigh the potential benefits for people 65 and older are identified:
| “Clinicians should use caution in prescribing anti-muscarinics in the frail OAB patient.” Clinical Principle |
Dr. Lightner gave another example of the evolution in OAB treatment when she highlighted statement #19. This statement is listed under non-FDA-approved treatments in the guidelines and it refers to the use of intradetrusor onabotulinumtoxinA, which recently was approved for treatment of non-neurogenic OAB in adults:
| “Clinicians may offer intradetrusor onabotulinumtoxinA as third-line treatment in the carefully-selected and thoroughly-counseled patient who has been refractory to first- and second-line OAB treatments. The patient must be able and willing to return for frequent post-void residual evaluation and able and willing to perform self-catheterization if necessary.” Option (Evidence Strength Grade C) |
Finally, Dr. Lightner mentioned two statements that bring up situations where all clinicians need to exercise caution when treating non-neurogenic OAB patients, #20 and #21:
|
“Indwelling catheters (including transurethral, suprapubic, etc.) are not recommended as a management strategy for OAB because of the adverse risk/benefit balance, except as a last resort in selected patients.” Expert Opinion “In rare cases, augmentation cystoplasty or urinary diversion for severe, refractory, complicated OAB patients may be considered.” Expert Opinion |
As a conclusion, Dr. Lightner showed the “Diagnosis & Treatment Algorithm” developed by the OAB guidelines panel. This algorithm is a useful tool for clinicians who may not treat OAB patients on a daily basis:
Dr. Lightner ended this overview/summary of the AUA/SUFU guidelines for Diagnosis and Treatment of OAB (Non-Neurogenic) in Adults by telling the audience that the panel encourages modifications to the OAB guidelines so they may provide an even better clinical framework in the future.
Below please find a link to the Adult OAB Guidelines plus the Diagnosis & Treatment Algorithm as posted on the AUA website.
www.auanet.org/content/media/OAB_guideline.pdf
www.auanet.org/content/media/OAB_algorithm.pdf
In addition, please find a link to an “AUA Guidelines at a Glance App” that Dr. Lightner provided. This App includes 18 AUA Guidelines and Best Practice Statements: itunes.apple.com/us/app/aua-guidelines-at-a-glance/id524710214?ls=1&mt=8
Presented by Deborah J. Lightner, MD at the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) 2013 Winter Meeting - February 26 - March 2, 2013 - Caesar's Palace - Las Vegas, NV USA
Mayo Clinic
Rochester, MN USA
Written by Anna Forsberg, medical reporter for UroToday.com
View Full SUFU 2013 Winter Meeting Coverage