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Behavioral Treatment of Overactive Bladder in Men

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: Behavioral training (Behavioral); Oxybutynin chloride, extended-release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Kathryn L. Burgio, PhD MA BA, Principal Investigator, Affiliation: Department of Veterans Affairs


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.

Clinical Details

Official title: Behavioral Treatment of Overactive Bladder in Men

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 24-hour Voiding Frequency

Secondary outcome:

Change in Nocturia Frequency

Change in Urgency Severity

Percent Change in Frequency of Urge Incontinence

Change on American Urological Association (AUA) Symptom Index

Patient Global Perception of Improvement (GPI)

Patient Satisfaction

Patient Global Rating of Activity Restriction

Patient Report of Symptom Distress

Patient Global Rating of Bothersomeness of Side Effects

Patient Desire for Alternate Treatment

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.


Minimum age: 19 Years. Maximum age: N/A. Gender(s): Male.


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

Locations and Contacts

Birmingham VA Medical Center, Birmingham, Alabama 35233, United States

Atlanta VA Medical and Rehab Center, Decatur, Decatur, Georgia 30033, United States

Additional Information

Starting date: January 2005
Last updated: April 22, 2014

Page last updated: August 23, 2015

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