Behavioral Treatment of Overactive Bladder in Men

Study Overview
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Brief Summary
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The primary purpose of this project is to evaluate the effectiveness of behavioral treatment compared to standard drug therapy for symptoms of OAB in male veterans.

Detailed Description
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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.

Official Title
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Behavioral Treatment of Overactive Bladder in Men

Conditions
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Overactive Bladder

Intervention / Treatment
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* Behavioral: Behavioral training
* Drug: Oxybutynin chloride, extended-release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Community-dwelling Veteran Self-reported urgency Self-reported frequent urination Mean of > 8 voids per 24-hour day on bladder diary Able to come to clinic Exclusion Criteria: Urologic surgery in the past 6 months Nonambulatory (unless has independent transfer skills) Flow rate < 5mL at baseline and < 10mL/sec after run-in (on simple uroflowmetry) Post-void residual urine volume > 250mL at baseline and > 150mL after run-in (on bladder ultrasound) Continual leakage Urinary tract infection (growth of > 100,000 colonies per ml of a urinary pathogen on urine culture). May be reconsidered after treatment and negative culture. Fecal impaction Poorly controlled diabetes (glycosylated hemoglobin >9 within last 3 months) Hematuria on microscopic examination in the absence of infection Any unstable medical condition (particularly: decompensated congestive heart failure, malignant arrhythmias, unstable angina) -- Impaired mental status (< 24 on Folstein's Mini-Mental State Exam) Narrow angle glaucoma Gastric retention (by medical history) Hypersensitivity to tamsulosin or oxybutynin Current use of anticholinergic agents for detrusor instability. May be reconsidered after 2-week wash-out. If on diuretic, dose has not been stable for at least three months Sleep apnea, unless surgically corrected

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Training<br>Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training | Behavioral: Behavioral training<br>* 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.<br>* Other names: Behavioral treatment;|
| Active Comparator: Drug Therapy<br>Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg | Drug: Oxybutynin chloride, extended-release<br>* 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.<br>* Other names: Antimuscarinic medication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Voiding Frequency | Mean voiding frequency per 24 hours derived from 7-day bladder dairy | post-treatment (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nocturia Frequency | Change in frequency of nocturia episodes based on 7-day bladder diary | baseline to post-treatment (week 8) | 
| Change in Urgency Severity | 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. | baseline to post-treatment (week 8) | 
| Percent Change in Frequency of Urge Incontinence | 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). | baseline to post-treatment (week 8) | 
| Change on American Urological Association (AUA) Symptom Index | 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. | baseline to post-treatment (week 8) | 
| Patient Global Perception of Improvement (GPI) | Patient global perception of improvement (much better to much worse) | post-treatment (week 8) | 
| Patient Satisfaction | Patient global rating of satisfaction with progress in treatment (completely satisfied to very dissatisfied) | post-treatment (week 8) | 
| Patient Global Rating of Activity Restriction | Patient global rating of activity restriction (not at all to all the time) | post-treatment (week 8) | 
| Patient Report of Symptom Distress | Patient report of how disturbed they were by symptoms (not at all to extremely) | post-treatment (week 8) | 
| Patient Global Rating of Bothersomeness of Side Effects | Patient global rating of how bothersome their side effects were (no side effects to extremely bothersome) | post-treatment (week 8) | 
| Patient Desire for Alternate Treatment | Patient response to Do you wish to receive another form of treatment? (yes) | post-treatment (week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Behavioral treatment, Drug therapy, Lower urinary tract symptoms, Urinary incontinence, Clinical trial