BERKELEY, CA (UroToday.com) - Although behavioral modification strategies (e.g., bladder training, lifestyle modifications, and pelvic floor muscle exercises) and antimuscarinic agents are first-line treatments for overactive bladder (OAB) symptoms, including urgency urinary incontinence (UUI), no formal consensus exists on the definition of a treatment response or non-response. Based on the definitions of treatment response in the medical literature describing clinical trials of non-neurogenic OAB treatment, we concluded that standardization of clinically meaningful definitions of treatment response and non-response is warranted. The definition of treatment response also should consider the individual patient or patient population under consideration. For many OAB patients experiencing UUI episodes, complete continence is not attained with treatment. Based on this finding and the published definitions of treatment response from our systematic review of the medical literature, we recommend that treatment response in patients with OAB, including UUI, be defined as a ≥ 50% decrease in UUI episodes, which is supported by a clinically meaningful improvement in patient-reported health-related quality of life (HRQL). Likewise, a non-responder would be defined as a patient with < 50% decrease in UUI episodes during treatment.
The goal of treatment for patients with OAB is improvement in urinary symptoms and HRQL. However, individual patients with OAB present with different symptoms, different levels of symptom severity, and different levels of symptom-related bother. The International Continence Society definition of OAB syndrome is urgency, with or without UUI, usually with frequency and nocturia.[2, 3] Although a percentage reduction in urinary urgency episodes has been used to define treatment response, urgency can be difficult to define and measure objectively. The number of urinary episodes is easily measured, but frequency is affected by patient perception of normal and various patient factors (e.g., medications, fluid intake). As a result, our literature search indicated that UUI is the OAB symptom most commonly used to define treatment response.
A standardized definition of treatment response in patients with OAB should help clinicians in a clinical practice setting when evaluating the balance between treatment efficacy and tolerability, assessing the need to switch or change treatments, and initiating discussions with patients on their treatment expectations and goals. Realistic patient treatment expectations and goals may improve patient adherence with treatment and improve treatment satisfaction; furthermore, clinicians may better understand the OAB symptoms and HRQL concerns that are most important to each patient. Validated measures that assess the patient-reported outcomes of HRQL, treatment satisfaction, and treatment expectations and goals can be used in clinical practice to confirm that a treatment response based on OAB symptoms is clinically meaningful to the patient. Overall, based on our review of the literature, for patients who have UUI as part of the OAB symptom complex, a ≥ 50% reduction in UUI episodes should be considered a positive treatment response.
- Goldman HB, Wyndaele JJ, Kaplan SA, et al. Defining response and non-response to treatment in patients with overactive bladder: a systematic review. Curr Med Res Opin. 2013; Nov 25 (Epub ahead of print)
- Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78
- Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20
Howard B. Goldman,a Jean-Jacques Wyndaele,b Steven A. Kaplan,c Joseph T. Wang,d and Fady Ntaniosd as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.
aCleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio; bUniversity Hospital Antwerp and University of Antwerp, Antwerp, Belgium; cWeill Cornell Medical College, Cornell University, New York, New York; dPfizer Inc, New York, New York
Howard B. Goldman MD
9500 Euclid Ave/Q10
Glickman Urological and Kidney Institute
Cleveland, OH 44195 USA
H.B.G. is a paid consultant to Allergan, Astellas Pharma, Medtronic, and Pfizer Inc.
S.A.K. and J.-J.W. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.
J.T.W. was an employee of Pfizer Inc at the time this study was conducted.
F.N. is an employee of Pfizer Inc.
Funding for the study was provided by Pfizer Inc. Medical writing assistance for this commentary was provided by Patricia B. Leinen, PhD, of Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.