Trial Outcomes & Findings for Enhancing Conservative Treatment for Urge Incontinence (NCT NCT00223821)
NCT ID: NCT00223821
Last Updated: 2013-12-19
Results Overview
Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
Baseline and immediately post-treatment - week 8
Results posted on
2013-12-19
Participant Flow
Participants were community-dwelling women with urge predominant incontinence recruited between July 2003 and January 2008.
Of the 166 women enrolled, 58 were found to be ineligible on clinical evaluation, 44 withdrew, and 64 were randomized.
Participant milestones
| Measure |
Drug Therapy Alone
drug therapy alone
Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.
|
Drug Therapy + Behavioral Training
drug therapy + behavioral training
Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.
Behavior Training: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
Completed Therapy
|
31
|
28
|
|
Overall Study
Completed Post-treatment Assessment
|
31
|
27
|
|
Overall Study
Completed 6-month Follow-up
|
28
|
25
|
|
Overall Study
COMPLETED
|
28
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Conservative Treatment for Urge Incontinence
Baseline characteristics by cohort
| Measure |
Arm 1
n=32 Participants
drug therapy alone
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
|
Arm 2
n=32 Participants
drug therapy + behavioral training
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Incontinence type
Urge only
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Incontinence type
Mixed urge + stress
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Incontinence type
missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Incontinence severity
Mild (less than 5 episodes/wk)
|
4 participant
n=5 Participants
|
4 participant
n=7 Participants
|
8 participant
n=5 Participants
|
|
Incontinence severity
Moderate (5-10 episodes/wk)
|
7 participant
n=5 Participants
|
10 participant
n=7 Participants
|
17 participant
n=5 Participants
|
|
Incontinence severity
Severe (> 10 episodes/wk)
|
21 participant
n=5 Participants
|
18 participant
n=7 Participants
|
39 participant
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and immediately post-treatment - week 8Population: Intention to treat
Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.
Outcome measures
| Measure |
Drug Therapy Alone
n=32 Participants
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
|
Drug Therapy + Behavioral Training
n=32 Participants
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
|
|---|---|---|
|
Change in Incontinent Episodes Immediately Post-treatment
|
-88.5 percentage change
Standard Deviation 24.0
|
-78.3 percentage change
Standard Deviation 32.6
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-treatmentPopulation: Intention to treat
Percent change from baseline in weekly frequency of incontinent episodes at 12-months post-treatment, derived from baseline and 12-month seven-day bladder diaries
Outcome measures
| Measure |
Drug Therapy Alone
n=32 Participants
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
|
Drug Therapy + Behavioral Training
n=32 Participants
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
|
|---|---|---|
|
Change in Incontinent Episodes at 12-month Follow-up
|
-82.0 percent change
Standard Deviation 26.1
|
-75.2 percent change
Standard Deviation 33.4
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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