Behavioral Treatment of Overactive Bladder in Men (MOTIVE)

April 22, 2014 updated by: US 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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Birmingham VA Medical Center
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical and Rehab Center, Decatur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Antimuscarinic medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour Voiding Frequency
Time Frame: post-treatment (week 8)
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
Time Frame: baseline to post-treatment (week 8)
Change in frequency of nocturia episodes based on 7-day bladder diary
baseline to post-treatment (week 8)
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

  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.
baseline to post-treatment (week 8)
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).
baseline to post-treatment (week 8)
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.
baseline to post-treatment (week 8)
Patient Global Perception of Improvement (GPI)
Time Frame: post-treatment (week 8)
Patient global perception of improvement ("much better" to "much worse")
post-treatment (week 8)
Patient Satisfaction
Time Frame: post-treatment (week 8)
Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")
post-treatment (week 8)
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")
post-treatment (week 8)
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")
post-treatment (week 8)
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")
post-treatment (week 8)
Patient Desire for Alternate Treatment
Time Frame: post-treatment (week 8)
Patient response to "Do you wish to receive another form of treatment?" (yes)
post-treatment (week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Kathryn L. Burgio, PhD MA BA, Birmingham, Alabama VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3083-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overactive Bladder

Clinical Trials on Behavioral training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe