Trial Outcomes & Findings for Behavioral Treatment of Overactive Bladder in Men (NCT NCT01187498)
NCT ID: NCT01187498
Last Updated: 2014-05-20
Results Overview
Mean voiding frequency per 24 hours derived from 7-day bladder dairy
COMPLETED
PHASE3
143 participants
post-treatment (week 8)
2014-05-20
Participant Flow
Participants were recruited through mailed surveys about bladder symptoms and through clinics at two Veterans Affairs Medical Centers(2005-2009).
To minimize possible effect of undetected obstruction we used a 4-week alpha-blocker run-in (tamsulosin 0.4 mg/d or alternative). Participants who continued to meet inclusion criteria after run-in were randomized. Alpha-blocker therapy was continued throughout the trial, unless not tolerated.
Participant milestones
| Measure |
Behavioral Training
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
Individually titrated, extended-release oxybutynin chloride, 5-30mg
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
70
|
|
Overall Study
COMPLETED
|
64
|
60
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Treatment of Overactive Bladder in Men
Baseline characteristics by cohort
| Measure |
Behavioral Training
n=73 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=70 Participants
Individually titrated, extended release oxybutynin chloride
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
70 participants
n=7 Participants
|
143 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post-treatment (week 8)Population: Treatment completers
Mean voiding frequency per 24 hours derived from 7-day bladder dairy
Outcome measures
| Measure |
Behavioral Training
n=64 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
24-hour Voiding Frequency
|
9.1 voids per 24-hour day
Standard Deviation 2.5
|
9.5 voids per 24-hour day
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: baseline to post-treatment (week 8)Change in frequency of nocturia episodes based on 7-day bladder diary
Outcome measures
| Measure |
Behavioral Training
n=64 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Change in Nocturia Frequency
|
-0.70 nocturia episodes per night
Standard Deviation .72
|
-.32 nocturia episodes per night
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: baseline to post-treatment (week 8)Population: Participants who completed treatment and returned bladder diary with useable urgency scores
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.
Outcome measures
| Measure |
Behavioral Training
n=61 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Change in Urgency Severity
|
.04 Score on scale
Standard Deviation .58
|
-.15 Score on scale
Standard Deviation .42
|
SECONDARY outcome
Timeframe: baseline to post-treatment (week 8)Population: Included participants who experienced incontinence at baseline only
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).
Outcome measures
| Measure |
Behavioral Training
n=22 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=24 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Percent Change in Frequency of Urge Incontinence
|
87.2 Percent change in episodes per week
Standard Deviation .25
|
75.6 Percent change in episodes per week
Standard Deviation .36
|
SECONDARY outcome
Timeframe: baseline to post-treatment (week 8)Population: Completers
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.
Outcome measures
| Measure |
Behavioral Training
n=64 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Change on American Urological Association (AUA) Symptom Index
|
3.4 Scores on the scale
Standard Deviation 4.6
|
3.2 Scores on the scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: post-treatment (week 8)Population: Completers minus one missing value
Patient global perception of improvement ("much better" to "much worse")
Outcome measures
| Measure |
Behavioral Training
n=63 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Patient Global Perception of Improvement (GPI)
Much better
|
23 participants
|
18 participants
|
|
Patient Global Perception of Improvement (GPI)
Better
|
30 participants
|
34 participants
|
|
Patient Global Perception of Improvement (GPI)
About the same
|
10 participants
|
7 participants
|
|
Patient Global Perception of Improvement (GPI)
Worse
|
0 participants
|
1 participants
|
|
Patient Global Perception of Improvement (GPI)
Much worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: post-treatment (week 8)Population: Completers minus one missing value
Patient global rating of satisfaction with progress in treatment ("completely satisfied" to "very dissatisfied")
Outcome measures
| Measure |
Behavioral Training
n=63 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Patient Satisfaction
Completely satisfied
|
36 participants
|
25 participants
|
|
Patient Satisfaction
Somewhat satisfied
|
25 participants
|
33 participants
|
|
Patient Satisfaction
Somewhat dissatisfied
|
2 participants
|
2 participants
|
|
Patient Satisfaction
Very Dissatisfied
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: post-treatment (week 8)Population: Com0leters minus one missing value
Patient global rating of activity restriction ("not at all" to "all the time")
Outcome measures
| Measure |
Behavioral Training
n=63 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Patient Global Rating of Activity Restriction
Not at all
|
29 participants
|
31 participants
|
|
Patient Global Rating of Activity Restriction
Slightly
|
19 participants
|
15 participants
|
|
Patient Global Rating of Activity Restriction
Some of the time
|
11 participants
|
13 participants
|
|
Patient Global Rating of Activity Restriction
All the time
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: post-treatment (week 8)Population: Completers minos one missing value
Patient report of how disturbed they were by symptoms ("not at all" to "extremely")
Outcome measures
| Measure |
Behavioral Training
n=63 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Patient Report of Symptom Distress
Not at all
|
19 participants
|
17 participants
|
|
Patient Report of Symptom Distress
Slightly
|
30 participants
|
35 participants
|
|
Patient Report of Symptom Distress
Somewhat
|
14 participants
|
7 participants
|
|
Patient Report of Symptom Distress
All the time
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: post-treatment (week 8)Population: Completers minus one missing value
Patient global rating of how bothersome their side effects were ("no side effects" to "extremely bothersome")
Outcome measures
| Measure |
Behavioral Training
n=63 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Patient Global Rating of Bothersomeness of Side Effects
No side effects
|
23 participants
|
11 participants
|
|
Patient Global Rating of Bothersomeness of Side Effects
Not at all bothersome
|
16 participants
|
13 participants
|
|
Patient Global Rating of Bothersomeness of Side Effects
A Little
|
16 participants
|
19 participants
|
|
Patient Global Rating of Bothersomeness of Side Effects
Somewhat
|
7 participants
|
13 participants
|
|
Patient Global Rating of Bothersomeness of Side Effects
Extremely
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: post-treatment (week 8)Population: Completers minus one missing value
Patient response to "Do you wish to receive another form of treatment?" (yes)
Outcome measures
| Measure |
Behavioral Training
n=63 Participants
Delayed voiding, urge suppression techniques, pelvic floor muscle training
|
Drug Therapy
n=60 Participants
Individually titrated, extended release oxybutynin chloride
|
|---|---|---|
|
Patient Desire for Alternate Treatment
|
18 participants
|
30 participants
|
Adverse Events
Behavioral Training
Drug Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place