NCT01187498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

May 20, 2014

Completed
Last Updated

May 20, 2014

Status Verified

December 1, 2013

Enrollment Period

4.8 years

First QC Date

August 20, 2010

Results QC Date

October 28, 2013

Last Update Submit

April 22, 2014

Conditions

Overactive Bladder

Keywords

Overactive bladderBehavioral treatmentDrug therapyLower urinary tract symptomsUrinary incontinenceClinical trial

Outcome Measures

Primary Outcomes (1)

  • 24-hour Voiding Frequency

    Mean voiding frequency per 24 hours derived from 7-day bladder dairy

    post-treatment (week 8)

Secondary Outcomes (10)

  • Change in Nocturia Frequency

    baseline to post-treatment (week 8)

  • Change in Urgency Severity

    baseline to post-treatment (week 8)

  • Percent Change in Frequency of Urge Incontinence

    baseline to post-treatment (week 8)

  • Change on American Urological Association (AUA) Symptom Index

    baseline to post-treatment (week 8)

  • Patient Global Perception of Improvement (GPI)

    post-treatment (week 8)

  • +5 more secondary outcomes

Study Arms (2)

Behavioral Training

EXPERIMENTAL

Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training

Behavioral: Behavioral training

Drug Therapy

ACTIVE COMPARATOR

Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg

Drug: Oxybutynin chloride, extended-release

Interventions

Behavioral trainingBEHAVIORAL

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.

Also known as: Behavioral treatment
Behavioral Training
Oxybutynin chloride, extended-releaseDRUG

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.

Also known as: Antimuscarinic medication
Drug Therapy

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Related Publications (3)

  • Burgio KL, Goode PS, Johnson TM, Hammontree L, Ouslander JG, Markland AD, Colli J, Vaughan CP, Redden DT. Behavioral versus drug treatment for overactive bladder in men: the Male Overactive Bladder Treatment in Veterans (MOTIVE) Trial. J Am Geriatr Soc. 2011 Dec;59(12):2209-16. doi: 10.1111/j.1532-5415.2011.03724.x. Epub 2011 Nov 7.

    PMID: 22092152RESULT

  • Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

    PMID: 37811598DERIVED

  • Johnson TM 2nd, Markland AD, Goode PS, Vaughan CP, Colli JL, Ouslander JG, Redden DT, McGwin G, Burgio KL. Efficacy of adding behavioural treatment or antimuscarinic drug therapy to alpha-blocker therapy in men with nocturia. BJU Int. 2013 Jul;112(1):100-8. doi: 10.1111/j.1464-410X.2012.11736.x. Epub 2013 Feb 28.

    PMID: 23448285DERIVED

MeSH Terms

Conditions

Urinary Bladder, OveractiveLower Urinary Tract SymptomsUrinary Incontinence

Interventions

Behavior Therapyoxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Results can only be generalized to men without evidence of obstruction as determined by uroflowmetry, post-void residual urine (PVR) volume, and a trial of an alpha-blocker.

Results Point of Contact

Title
Kathryn L. Burgio, PhD
Organization
Birmingham VA Medical Center
kburgio@uabmc.edu
205-558-7064

Study Officials

  • Kathryn L. Burgio, PhD MA BA

    Birmingham, Alabama VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2010

First Posted

August 24, 2010

Study Start

January 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 20, 2014

Results First Posted

May 20, 2014

Record last verified: 2013-12

Locations

US(2)