Behavioral Treatment of Overactive Bladder in Men (MOTIVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01187498
First received: August 20, 2010
Last updated: April 22, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Behavioral: Behavioral training
Drug: Oxybutynin chloride, extended-release
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Treatment of Overactive Bladder in Men

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 24-hour Voiding Frequency [ Time Frame: post-treatment (week 8) ] [ Designated as safety issue: No ]
    Mean voiding frequency per 24 hours derived from 7-day bladder dairy


Secondary Outcome Measures:
  • Change in Nocturia Frequency [ Time Frame: baseline to post-treatment (week 8) ] [ Designated as safety issue: No ]
    Change in frequency of nocturia episodes based on 7-day bladder diary

  • Change in Urgency Severity [ Time Frame: baseline to post-treatment (week 8) ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline to post-treatment (week 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to post-treatment (week 8) ] [ Designated as safety issue: No ]
    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) [ Time Frame: post-treatment (week 8) ] [ Designated as safety issue: No ]
    Patient global perception of improvement ("much better" to "much worse")

  • Patient Satisfaction [ Time Frame: post-treatment (week 8) ] [ Designated as safety issue: No ]
    Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")

  • Patient Global Rating of Activity Restriction [ Time Frame: post-treatment (week 8) ] [ Designated as safety issue: No ]
    Patient global rating of activity restriction ("not at all" to "all the time")

  • Patient Report of Symptom Distress [ Time Frame: post-treatment (week 8) ] [ Designated as safety issue: No ]
    Patient report of how disturbed they were by symptoms ("not at all" to "extremely")

  • Patient Global Rating of Bothersomeness of Side Effects [ Time Frame: post-treatment (week 8) ] [ Designated as safety issue: No ]
    Patient global rating of how bothersome their side effects were ("no side effects" to "extremely bothersome")

  • Patient Desire for Alternate Treatment [ Time Frame: post-treatment (week 8) ] [ Designated as safety issue: No ]
    Patient response to "Do you wish to receive another form of treatment?" (yes)


Enrollment: 143
Study Start Date: January 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Antimuscarinic medication

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187498

Locations
United States, Alabama
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Investigators
Principal Investigator: Kathryn L. Burgio, PhD MA BA Department of Veterans Affairs
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01187498     History of Changes
Other Study ID Numbers: B3083-R
Study First Received: August 20, 2010
Results First Received: October 28, 2013
Last Updated: April 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Overactive bladder
Behavioral treatment
Drug therapy
Lower urinary tract symptoms
Urinary incontinence
Clinical trial

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Oxybutynin
Mandelic Acids
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on July 26, 2014