Combined Behavioral and Drug Treatment of Overactive Bladder in Men
Principal Investigator: KATHRYN LARSEN BURGIO
Affiliation: University of Alabama at Birmingham
Abstract: Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome symptoms of urgency, frequent urination, urge incontinence, and nocturia, and impacts the lives of millions of men. OAB symptoms are most often treated with pharmacologic therapies (alpha-blocking agents and/or antimuscarinic agents) or behavioral treatments. Although drug therapies (even combined drug therapies) and behavioral treatments reduce OAB symptoms, few patients are completely cured with either treatment alone. Therefore, there is a need to improve interventions for this common problem. The primary purpose of this project is to test the effectiveness of combining behavioral treatment and drug therapy as a way to improve outcomes in the treatment of OAB symptoms in men. The second purpose of the study is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. a stepped program, in which therapies are combined following behavioral or drug therapy alone. The third purpose of the study is to examine the costs and cost-effectiveness of combined behavioral + drug treatment compared to behavioral therapy alone and drug therapy alone. The proposed study will be a 2-phase, randomized clinical trial. Subjects will be 201 men with OAB as manifested by urgency and frequent urination (>8 voids per day), with or without incontinence and without significant obstruction. In Phase 1, patients will be randomized to 6 weeks of behavioral training alone, drug therapy alone, or combined behavioral + drug therapy. The behavioral treatment will be a comprehensive, behavioral training program, which includes pelvic floor muscle rehabilitation, self monitoring with bladder diaries, and teaching urge suppression and other skills to inhibit detrusor contraction and reduce urgency, frequency, incontinence, and nocturia. Drug therapy will consist of an anti-muscarinic (individually titrated, extended release oxybutynin) + an alpha blocker (tamsulosin 0.4mg daily). In Phase 2, after 6 weeks of treatment, patients randomized to combined therapy will be followed for an additional 6 weeks, and patients in behavioral or drug therapy alone will be crossed over to 6 weeks of combined behavioral + drug therapy to test the stepped approach. Outcomes will be assessed after each study phase (weeks 6 and 12). Bladder diaries completed by subjects before and after the treatment will be used to calculate reduction in the frequency of OAB symptoms (frequency of urination, urgency, urge incontinence, and nocturia). Secondary outcome measures will include patient satisfaction, symptom bother, and condition-specific as well as general health-related quality of life. Follow-up assessments will be conducted at 6 and 12 months. Though many clinicians use drug therapy routinely in the treatment of OAB, most do not offer behavioral treatments such as pelvic floor muscle training or urge suppression strategies for this problem. 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 symptoms of urgency, frequent urination, urge incontinence, and nocturia, and impacts the lives of millions of men. Although drug therapies and behavioral treatments reduce OAB 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 and more cost-effective outcomes than either treatment alone. Therefore, this study will yield important information related to optimizing treatment of OAB in men.
Funding Period: ----------------2009 - ---------------2011-
more information: NIH RePORT