Over Active Bladder Patients Having Sling Surgery
|ClinicalTrials.gov Identifier: NCT00852696|
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: Solifenacin Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double Blind, Randomized Placebo Controlled Trial of the Perioperative Use of Solifenacin in the Management of Postoperative Overactive Bladder Symptoms in Patients With Mixed Incontinence Undergoing Suburethral Sling Procedures.|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||February 2010|
Placebo Comparator: Placebo Group
Placebo Orally 9 weeks once daily.
Take orally once daily for 9 weeks.
Experimental: Solifenacin Group
Solifenacin Orally 9 weeks once daily.
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.
Other Name: Tolterodine Tartrate
- To assess the efficacy of solifenacin in the prevention of postoperative OAB symptoms (urinary frequency,urgency, urge incontinence, nocturia) in women undergoing sub-urethral sling placement for mixed urinary incontinence with primary stress symptoms. [ Time Frame: 11 weeks ]Reduction in overactive bladder symptoms
- Assess safety of Solifenacin in women having sub-urethral sling procedures, the perioperative period, on quality of life measures on length of hospitalization on the time to resumption of normal voiding in time to removal of suprapubic catheter. [ Time Frame: 11 weeks ]reduction in urinary incontinence
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852696
|United States, Florida|
|Cleveland Clinic Florida|
|Weston, Florida, United States, 33331|
|Principal Investigator:||G W Davila, MD||Cleeland Clinic|