drugset / Trial / NCT01092624

Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse

NCT01092624

Phase 4 Terminated 94 enrolled Hartford Hospital Astellas Pharma Inc · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the effect of pessary therapy, with and without Solifenacin (Vesicare), on symptoms of over active bladder and bladder function in women with overactive bladder symptoms and pelvic organ prolapse. Study Hypotheses: Null hypothesis, HO: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does not improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo. Alternate hypothesis, HA: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.

Timeline

Start
2010-03
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Solifenacin Small molecule 5 mg
Subject Solifenacin Small molecule 10 mg

Indications