Behavioral Treatment of Overactive Bladder in Men

Phase 3

Completed

Conditions: Overactive Bladder

Interventions: Behavioral: Behavioral training
Drug: Oxybutynin chloride, extended-release

Registration Number: NCT01187498

Lead Sponsor: US Department of Veterans Affairs

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 143

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Behavioral Training	Behavioral training	Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training
Drug Therapy	Oxybutynin chloride, extended-release	Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg

Primary Outcome Measures

Name	Time	Method
24-hour Voiding Frequency	post-treatment (week 8)	Mean voiding frequency per 24 hours derived from 7-day bladder dairy

Secondary Outcome Measures

Name	Time	Method
Change in Nocturia Frequency	baseline to post-treatment (week 8)	Change in frequency of nocturia episodes based on 7-day bladder diary
Change in Urgency Severity	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 1. Mild-awareness of urgency, but is easily tolerated. 2. Moderate-enough urgency discomfort that it interferes with or shortens usual activity 3. Severe-extreme urgency discomfort that abruptly stops all activities or tasks.
Percent Change in Frequency of Urge Incontinence	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	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)	post-treatment (week 8)	Patient global perception of improvement ("much better" to "much worse")
Patient Satisfaction	post-treatment (week 8)	Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")
Patient Global Rating of Activity Restriction	post-treatment (week 8)	Patient global rating of activity restriction ("not at all" to "all the time")
Patient Report of Symptom Distress	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	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	post-treatment (week 8)	Patient response to "Do you wish to receive another form of treatment?" (yes)

Trial Locations

Locations (2): Birmingham VA Medical Center
🇺🇸
Birmingham, Alabama, United States
Atlanta VA Medical and Rehab Center, Decatur
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Decatur, Georgia, United States