A Phase 3 interventional study of Behavioral training and Oxybutynin chloride, extended-release in Overactive Bladder, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2014-05-20.
Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Treatment
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.
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 143 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any unstable medical condition (particularly: decompensated congestive heart failure, malignant arrhythmias, unstable angina)
-- Impaired mental status (\< 24 on Folstein's Mini-Mental State Exam)
Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training
Behavioral: Behavioral training
Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg
Drug: Oxybutynin chloride, extended-release
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
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
24-hour Voiding Frequency
Mean voiding frequency per 24 hours derived from 7-day bladder dairy
Time frame: post-treatment (week 8)
Change in Nocturia Frequency
Change in frequency of nocturia episodes based on 7-day bladder diary
Time frame: 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 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.
Time frame: 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).
Time frame: 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.
Time frame: baseline to post-treatment (week 8)
Patient Global Perception of Improvement (GPI)
Patient global perception of improvement ("much better" to "much worse")
Time frame: post-treatment (week 8)
Patient Satisfaction
Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")
Time frame: post-treatment (week 8)
Patient Global Rating of Activity Restriction
Patient global rating of activity restriction ("not at all" to "all the time")
Time frame: post-treatment (week 8)
Patient Report of Symptom Distress
Patient report of how disturbed they were by symptoms ("not at all" to "extremely")
Time frame: 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")
Time frame: post-treatment (week 8)
Patient Desire for Alternate Treatment
Patient response to "Do you wish to receive another form of treatment?" (yes)
Time frame: post-treatment (week 8)
Participants were recruited through mailed surveys about bladder symptoms and through clinics at two Veterans Affairs Medical Centers(2005-2009).
| Milestone | Behavioral Training | Drug Therapy |
|---|---|---|
| Started | 73 | 70 |
| Completed | 64 | 60 |
| Not completed | 9 | 10 |
Mean voiding frequency per 24 hours derived from 7-day bladder dairy
| voids per 24-hour day | Behavioral Training | Drug Therapy |
|---|---|---|
| 24-hour Voiding Frequency | 9.1 ± 2.5 | 9.5 ± 2.4 |
Change in frequency of nocturia episodes based on 7-day bladder diary
| nocturia episodes per night | Behavioral Training | Drug Therapy |
|---|---|---|
| Change in Nocturia Frequency | -0.70 ± .72 | -.32 ± 1.28 |
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.
| Score on scale | Behavioral Training | Drug Therapy |
|---|---|---|
| Change in Urgency Severity | .04 ± .58 | -.15 ± .42 |
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).
| Percent change in episodes per week | Behavioral Training | Drug Therapy |
|---|---|---|
| Percent Change in Frequency of Urge Incontinence | 87.2 ± .25 | 75.6 ± .36 |
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.
| Scores on the scale | Behavioral Training | Drug Therapy |
|---|---|---|
| Change on American Urological Association (AUA) Symptom Index | 3.4 ± 4.6 | 3.2 ± 5.6 |
Patient global perception of improvement ("much better" to "much worse")
| participants | Behavioral Training | Drug Therapy |
|---|---|---|
| Much better | 23 | 18 |
| Better | 30 | 34 |
| About the same | 10 | 7 |
| Worse | 0 | 1 |
| Much worse | 0 | 0 |
Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")
| participants | Behavioral Training | Drug Therapy |
|---|---|---|
| Completely satisfied | 36 | 25 |
| Somewhat satisfied | 25 | 33 |
| Somewhat dissatisfied | 2 | 2 |
| Very Dissatisfied | 0 | 0 |
Patient global rating of activity restriction ("not at all" to "all the time")
| participants | Behavioral Training | Drug Therapy |
|---|---|---|
| Not at all | 29 | 31 |
| Slightly | 19 | 15 |
| Some of the time | 11 | 13 |
| All the time | 4 | 1 |
Patient report of how disturbed they were by symptoms ("not at all" to "extremely")
| participants | Behavioral Training | Drug Therapy |
|---|---|---|
| Not at all | 19 | 17 |
| Slightly | 30 | 35 |
| Somewhat | 14 | 7 |
| All the time | 0 | 1 |
Patient global rating of how bothersome their side effects were ("no side effects" to "extremely bothersome")
| participants | Behavioral Training | Drug Therapy |
|---|---|---|
| No side effects | 23 | 11 |
| Not at all bothersome | 16 | 13 |
| A Little | 16 | 19 |
| Somewhat | 7 | 13 |
| Extremely | 1 | 4 |
Patient response to "Do you wish to receive another form of treatment?" (yes)
| participants | Behavioral Training | Drug Therapy |
|---|---|---|
| Patient Desire for Alternate Treatment | 18 | 30 |
Collected over 8-week treatment period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Training | — | 0/73 (0%) | 0/73 (0%) |
| Drug Therapy | — | 0/70 (0%) | 0/70 (0%) |
| Age, Continuous(years) | Behavioral Training | Drug Therapy | Total |
|---|---|---|---|
| Mean | 63.7 ± 10.3 | 64.8 ± 9.6 | 64.2 ± 9.9 |
| Sex: Female, Male(Participants) | Behavioral Training | Drug Therapy | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 73 | 70 | 143 |
| Region of Enrollment(participants) | Behavioral Training | Drug Therapy | Total |
|---|---|---|---|
| United States | 73 | 70 | 143 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs