Behavioral Treatment of Overactive Bladder in Men (MOTIVE)
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|ClinicalTrials.gov Identifier: NCT01187498|
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : May 20, 2014
Last Update Posted : May 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Behavioral: Behavioral training Drug: Oxybutynin chloride, extended-release||Phase 3|
Overactive bladder (OAB) is a very common and bothersome condition manifested by urgency, frequent urination, urge urinary incontinence, and nocturia. Drug therapy with oxybutynin or tolterodine is the most common approach to treatment of OAB in VA Medical Center clinics and is the standard of care nationally. Although it improves symptoms of OAB for many patients, drug therapy often has side effects, which cause a significant number of patients to discontinue therapy. Further, many symptoms are not completely controlled, even while patients are on the medication. Therefore, there is a need to improve interventions for this common problem. Although behavioral treatment is a well-established treatment for urge urinary incontinence and frequency in women, there are no controlled trials of behavioral treatment for symptoms of OAB in men. The primary purpose of this project is to evaluate the effectiveness of behavioral treatment for symptoms of OAB in male veterans.
The study is a two-site (Birmingham and Atlanta) randomized clinical trial to evaluate the effects of behavioral training compared to a standard (drug) treatment control condition. Subjects are 143 men with OAB as manifested by urgency and frequent urination (>8 voids per day), with or without incontinence, and without significant bladder outlet obstruction. Following a run-in period in which all patients are treated with an alpha blocker to empirically treat any undetected obstruction, they are stratified on severity and presence of urge incontinence and randomized to 8 weeks of behavioral treatment or drug therapy. The behavioral treatment is 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, thus reducing urgency, frequency, incontinence, and nocturia. Patients in the control group receive standard therapy consisting of individually titrated, extended-release oxybutynin, a well-established pharmacologic agent with a state of the art drug delivery system that has the lowest rates of side effects. Bladder diaries completed by subjects prior to randomization and following the last treatment session are used to calculate changes in frequency of urination, as well as other symptoms of overactive bladder, including reports of urgency, incontinence, and nocturia. Secondary outcome measures include patient global ratings of satisfaction and improvement, impact of incontinence, and the American Urological Association (AUA) Symptom Index.
The second purpose of the study is to examine combined behavioral and drug therapy. Following post-treatment assessment, patients who do not achieve satisfactory outcomes with either behavioral or drug therapy alone are crossed over into a second phase, in which they receive combined treatment to improve outcome as much as possible.
This study will yield important information related to alternative treatment of OAB in male veterans. Though many clinicians use drug therapy routinely in the treatment of OAB, most do not offer behavioral treatments such as pelvic floor muscle training for this problem. Thus, this study has potential to alter standards of care for OAB in men.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Behavioral Treatment of Overactive Bladder in Men|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Experimental: Behavioral Training
Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training
Behavioral: Behavioral training
Comprehensive behavioral training program using delayed voiding, urge suppression techniques, pelvic floor muscle training, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.
Other Name: Behavioral treatment
Active Comparator: Drug Therapy
Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg
Drug: Oxybutynin chloride, extended-release
Individually titrated, extended-release oxybutynin chloride, initiated at 10 mg, fluid management handout, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.
Other Name: Antimuscarinic medication
- 24-hour Voiding Frequency [ Time Frame: post-treatment (week 8) ]Mean voiding frequency per 24 hours derived from 7-day bladder dairy
- Change in Nocturia Frequency [ Time Frame: baseline to post-treatment (week 8) ]Change in frequency of nocturia episodes based on 7-day bladder diary
- Change in Urgency Severity [ Time Frame: baseline to post-treatment (week 8) ]
Indevus Urgency Severity Scale incorporated into the 7-day bladder diary. Scores for urgency severity ranged from 0 to 3:
0: None-no urgency
- Mild-awareness of urgency, but is easily tolerated.
- Moderate-enough urgency discomfort that it interferes with or shortens usual activity
- Severe-extreme urgency discomfort that abruptly stops all activities or tasks.
- Percent Change in Frequency of Urge Incontinence [ Time Frame: baseline to post-treatment (week 8) ]Percent change in frequency of urge incontinence episodes based on 7-day bladder diary. Percent change was calculated as ([frequency at baseline] - [frequency at 8 weeks]) / (frequency at baseline).
- Change on American Urological Association (AUA) Symptom Index [ Time Frame: baseline to post-treatment (week 8) ]Change in score on American Urological Association (AUA) Symptom Index (baseline to week 8). The index measures lower urinary tract symptoms. Scores range from 0 to 35, with higher scores indicating worse symptoms.
- Patient Global Perception of Improvement (GPI) [ Time Frame: post-treatment (week 8) ]Patient global perception of improvement ("much better" to "much worse")
- Patient Satisfaction [ Time Frame: post-treatment (week 8) ]Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")
- Patient Global Rating of Activity Restriction [ Time Frame: post-treatment (week 8) ]Patient global rating of activity restriction ("not at all" to "all the time")
- Patient Report of Symptom Distress [ Time Frame: post-treatment (week 8) ]Patient report of how disturbed they were by symptoms ("not at all" to "extremely")
- Patient Global Rating of Bothersomeness of Side Effects [ Time Frame: post-treatment (week 8) ]Patient global rating of how bothersome their side effects were ("no side effects" to "extremely bothersome")
- Patient Desire for Alternate Treatment [ Time Frame: post-treatment (week 8) ]Patient response to "Do you wish to receive another form of treatment?" (yes)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187498
|United States, Alabama|
|Birmingham VA Medical Center|
|Birmingham, Alabama, United States, 35233|
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur|
|Decatur, Georgia, United States, 30033|
|Principal Investigator:||Kathryn L. Burgio, PhD MA BA||Birmingham, Alabama VA Medical Center|