Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome lower urinary tract symptoms (LUTS) of urgency, frequent urination, nocturia, or urgency incontinence, and impacts the lives of millions of men. These symptoms are most often treated with pharmacologic therapies (primarily alpha- blocking agents and/or antimuscarinic agents) or behavioral treatment (pelvic floor muscle training, urge suppression, delayed voiding). Although behavioral and drug therapies (even combined drug therapies) are effective, few patients are completely cured with either treatment alone. Thus, there is a need to improve interventions for OAB symptoms. The primary aim of this project is to evaluate the effectiveness of combined behavioral + drug therapy compared to behavioral treatment alone and drug therapy alone as a way to improve outcomes in the treatment of OAB symptoms in men.
The second aim i s to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. stepped therapy, in which therapies are combined following initial behavioral or drug therapy alone.
The third aim i s to examine the costs and cost- effectiveness of combined behavioral + drug therapy compared to behavioral or drug therapy alone. With two years of NIDDK ARRA funding, we have completed a pilot and feasibility study and laid the groundwork for this multi-site, 3-arm, randomized trial. Participants will be men 40 years of age with urgency and frequent urination (9 or more voids per 24-hours), with or without incontinence and without clinically significant obstruction. In stag 1, participants will be randomized to 6 weeks of behavioral training alone (pelvic floor muscle training + urge suppression + delayed voiding), drug therapy alone, (selective alpha-1a- receptor antagonist + antimuscarinic), or combined behavioral + drug therapy. In stage 2, participants in combined therapy will continue for an additional 6 weeks, and participants in behavioral or drug therapy alone will be stepped up to an additional 6 weeks of combined behavioral + drug therapy to test the stepped approach. Outcomes will be assessed after each stage of the study (weeks 6 and 12). Bladder diaries completed before and after treatment will be used to calculate reduction in the frequency of urination (primary outcome) and other targeted LUTS (urgency, urgency incontinence, and nocturia). Other outcome measures include validated patient global ratings of improvement and satisfaction, the Overactive Bladder Questionnaire to assess symptom bother and condition-specific quality of life, and the International Prostate Symptom Score questionnaire (IPSS) to assess symptoms. We hypothesize that combined therapy will result in better outcomes than either behavioral or drug therapy alone. We propose to include the participants already enrolled in the pilot and feasibility study (N=86) as a formal internal pilot and request funding to continue this trial as designed and initiated to completion of the needed sample (N=201). This study will yield important information related to optimizing treatment of OAB in men.

Public Health Relevance

Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome lower urinary tract symptoms (LUTS) of urgency, frequent voiding, incontinence, and nocturia, and impacts the lives of millions of men. Although drug therapies and behavioral therapy reduce these symptoms, few patients are completely cured with either treatment alone. This project will be a randomized controlled trial to examine whether combining behavioral and drug intervention will produce better outcomes than either treatment alone. This study will yield important information about optimizing treatment of OAB symptoms in men.

Agency
National Institute of Health (NIH)
Type
Research Project (R01)
Project #
5R01DK082548-05
Application #
8712470
Study Section
(UGPP)
Program Officer
Kirkali, Ziya
Project Start
Project End
Budget Start
Budget End
Support Year
5
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Burgio, Kathryn L; Kraus, Stephen R; Borello-France, Diane et al. (2010) The effects of drug and behavior therapy on urgency and voiding frequency. Int Urogynecol J Pelvic Floor Dysfunct 21:711-9
Burgio, Kathryn L; Kraus, Stephen R; Menefee, Shawn et al. (2008) Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med 149:161-9