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