Trial Outcomes & Findings for Over Active Bladder Patients Having Sling Surgery (NCT NCT00852696)

Results Overview

Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

9 weeks

Results posted on

2022-07-01

Participant Flow

Recruitment completed in a clinic setting for eligible participants.

1 subject enrolled, unknown patient assignment because this study was double blinded. To our knowledge, the participant never started this trial and no data was collected as study was terminated.

Participant milestones

Participant milestones
Measure	Solifenacin Group Solifenacin Orally 9 weeks once daily and standard of care. Solifenacin: Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks. Principal investigator left the institution, no data is available	Placebo Standard of care and placebo
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Over Active Bladder Patients Having Sling Surgery

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 9 weeks

Population: Principal investigator left the institution, no data is available. 1 subject enrolled, unknown patient assignment because this study was double blinded. Data was never collected for this study.

Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Solifenacin Group

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

Cecilia Calvo

Cleveland Clinic Florida

Phone: 954-659-5637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place