Overactive BladderPhase 3MOTIVENCT01187498
Behavioral Treatment of Overactive Bladder in Men
A Phase 3 study testing Behavioral training and Oxybutynin chloride, extended-release in people with Overactive Bladder, run by US Department of Veterans Affairs at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Behavioral training and Oxybutynin chloride, extended-release
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Oct 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Birmingham VA Medical Center
Birmingham, Alabama, 35233
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
About this study
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Behavioral training, Oxybutynin chloride, extended-release
- Keywords
- Overactive bladder, Behavioral treatment, Drug therapy, Lower urinary tract symptoms, Urinary incontinence, Clinical trial
- Medical subject headings
- Urinary Bladder, Overactive, Lower Urinary Tract Symptoms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral trainingBehavioural
Also called Behavioral treatment
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.
Oxybutynin chloride, extended-releaseDrug
Also called Antimuscarinic medication
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Training | Experimental | Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training Receives: Behavioral: Behavioral training |
| Drug Therapy | Active comparator | Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg Receives: Drug: Oxybutynin chloride, extended-release |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Voiding Frequency
Mean voiding frequency per 24 hours derived from 7-day bladder dairy
Measured: post-treatment (week 8)
Secondary outcomes (10)
Change in Nocturia Frequency
Change in frequency of nocturia episodes based on 7-day bladder diary
Measured: baseline to post-treatment (week 8)
Change in Urgency Severity
Indevus Urgency Severity Scale incorporated into the 7-day bladder diary. Scores for urgency severity ranged from 0 to 3:
0: None-no urgency
- Mild-awareness of urgency, but is easily tolerated.
- Moderate-enough urgency discomfort that it interferes with or shortens usual activity
- Severe-extreme urgency discomfort that abruptly stops all activities or tasks.
Measured: baseline to post-treatment (week 8)
Percent Change in Frequency of Urge Incontinence
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).
Measured: baseline to post-treatment (week 8)
Change on American Urological Association (AUA) Symptom Index
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.
Measured: baseline to post-treatment (week 8)
Patient Global Perception of Improvement (GPI)
Patient global perception of improvement ("much better" to "much worse")
Measured: post-treatment (week 8)
Patient Satisfaction
Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")
Measured: post-treatment (week 8)
Patient Global Rating of Activity Restriction
Patient global rating of activity restriction ("not at all" to "all the time")
Measured: post-treatment (week 8)
Patient Report of Symptom Distress
Patient report of how disturbed they were by symptoms ("not at all" to "extremely")
Measured: post-treatment (week 8)
Patient Global Rating of Bothersomeness of Side Effects
Patient global rating of how bothersome their side effects were ("no side effects" to "extremely bothersome")
Measured: post-treatment (week 8)
Patient Desire for Alternate Treatment
Patient response to "Do you wish to receive another form of treatment?" (yes)
Measured: post-treatment (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startJan 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kathryn L. Burgio, PhD MA BA, Principal investigator, Birmingham, Alabama VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187498
- Sponsor's protocol ID
- B3083-R
- Acronym
- MOTIVE
- Status last verified
- Dec 2013
- First submitted
- 20 Aug 2010
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22092152Funada 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.
PubMed 37811598Johnson 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.
PubMed 23448285
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment of Overactive Bladder in Men
- ClinicalTrials.gov ID
- NCT01187498
- Acronym / sponsor ID
- MOTIVE / B3083-R
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Behavioral treatment, Drug therapy, Lower urinary tract symptoms, Urinary incontinence, Clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Posted 20 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Training | Experimental | Behavioral: Behavioral trainingBehavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training |
| Drug Therapy | Active comparator | Drug: Oxybutynin chloride, extended-releaseOxybutynin chloride, extended-release, individually-titrated, 5-30 mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male
- Community-dwelling
- Veteran
- Self-reported urgency
- Self-reported frequent urination
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral trainingAlso: Behavioral treatmentComprehensive 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. | Behavioural | Behavioral Training |
| Oxybutynin chloride, extended-releaseAlso: Antimuscarinic medicationIndividually 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. | Drug | Drug Therapy |
Primary outcome
24-hour Voiding Frequency
Time frame: post-treatment (week 8)
Mean voiding frequency per 24 hours derived from 7-day bladder dairy
10 secondary outcomes
Change in Nocturia Frequency
Time frame: baseline to post-treatment (week 8)
Change in Urgency Severity
Time frame: baseline to post-treatment (week 8)
Percent Change in Frequency of Urge Incontinence
Time frame: baseline to post-treatment (week 8)
Change on American Urological Association (AUA) Symptom Index
Time frame: baseline to post-treatment (week 8)
Patient Global Perception of Improvement (GPI)
Time frame: post-treatment (week 8)
Patient Satisfaction
Time frame: post-treatment (week 8)
Patient Global Rating of Activity Restriction
Time frame: post-treatment (week 8)
Patient Report of Symptom Distress
Time frame: post-treatment (week 8)
Patient Global Rating of Bothersomeness of Side Effects
Time frame: post-treatment (week 8)
Patient Desire for Alternate Treatment
Time frame: post-treatment (week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22092152Burgio 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.
- Derived from this study: PubMed 37811598Funada 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.
- Derived from this study: PubMed 23448285Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn L. Burgio, PhD MA BA principal investigator
Birmingham, Alabama VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral training and Oxybutynin chloride, extended-release in people with Overactive Bladder, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Voiding Frequency (time frame: post-treatment (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01187498, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.