Trial Outcomes & Findings for Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES) (NCT NCT00862745)
NCT ID: NCT00862745
Last Updated: 2011-11-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
645 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2011-11-24
Participant Flow
Participants were recruited from the general community surrounding 13 clinical sites across the United States between January 2009 and December 2009.
Participants screened over 4 week period.
Participant milestones
| Measure |
Fesoterodine
fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
|
Placebo
placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
|
|---|---|---|
|
Randomized Control Trial
STARTED
|
322
|
323
|
|
Randomized Control Trial
COMPLETED
|
284
|
284
|
|
Randomized Control Trial
NOT COMPLETED
|
38
|
39
|
|
Open-label Follow-up
STARTED
|
268
|
274
|
|
Open-label Follow-up
COMPLETED
|
229
|
225
|
|
Open-label Follow-up
NOT COMPLETED
|
39
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
Baseline characteristics by cohort
| Measure |
Fesoterodine
n=322 Participants
fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
|
Placebo
n=323 Participants
placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
|
Total
n=645 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
230 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
464 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
92 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Age Continuous
|
56.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
322 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
645 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
322 participants
n=5 Participants
|
323 participants
n=7 Participants
|
645 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The population analyzed included all participants receiving at least 1 dose of study intervention.
Outcome measures
| Measure |
Fesoterodine
n=303 Participants
fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
|
Placebo
n=301 Participants
placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
|
|---|---|---|
|
Change in Frequency of Urge Urinary Incontinence Episodes at Week 12.
|
-2.5 episodes
Standard Deviation 2.5
|
-1.8 episodes
Standard Deviation 2.7
|
Adverse Events
Fesoterodine
Serious events: 4 serious events
Other events: 148 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fesoterodine
n=322 participants at risk
fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
|
Placebo
n=323 participants at risk
placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
|
|---|---|---|
|
Endocrine disorders
Hospitalized for Diabetes
|
0.00%
0/322 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.31%
1/323 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for Shortness of Breath
|
0.00%
0/322 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.31%
1/323 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Cardiac disorders
Emergency Room Visit for Angina
|
0.00%
0/322 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.31%
1/323 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Gastrointestinal disorders
Hospitalization for Pancreatitis
|
0.00%
0/322 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.31%
1/323 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Cardiac disorders
Hosptialized for Myocardial Infarction
|
0.31%
1/322 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.00%
0/323 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Pulmonary embolus
|
0.31%
1/322 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.00%
0/323 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.31%
1/322 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.00%
0/323 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Gastrointestinal disorders
Hospitalization for Colitis
|
0.31%
1/322 • Number of events 1 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.00%
0/323 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
Other adverse events
| Measure |
Fesoterodine
n=322 participants at risk
fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
|
Placebo
n=323 participants at risk
placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dry eyes/mouth/throat
|
33.2%
107/322 • Number of events 137 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
11.8%
38/323 • Number of events 54 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Gastrointestinal disorders
Constipation
|
7.5%
24/322 • Number of events 27 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
5.3%
17/323 • Number of events 17 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Nervous system disorders
Headache
|
5.9%
19/322 • Number of events 22 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
3.1%
10/323 • Number of events 10 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Infections and infestations
Cold/flu
|
6.5%
21/322 • Number of events 21 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
4.6%
15/323 • Number of events 16 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Renal and urinary disorders
Urinary tract infection
|
5.3%
17/322 • Number of events 19 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
4.3%
14/323 • Number of events 14 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
10/322 • Number of events 13 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
1.5%
5/323 • Number of events 5 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Gastrointestinal disorders
Nausea
|
3.1%
10/322 • Number of events 11 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
2.5%
8/323 • Number of events 8 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Infections and infestations
Runny/stuffy nose, sinus congestion
|
2.5%
8/322 • Number of events 9 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
3.1%
10/323 • Number of events 10 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
9/322 • Number of events 9 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
0.93%
3/323 • Number of events 3 • Baseline through Week 12 (Randomized Control Trial portion of the study).
|
Additional Information
Dr. Jeanette Brown
University of California, San Francisco
Phone: 415-353-9751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place