drugset / Trial / NCT01092624
Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Solifenacin | Small molecule | 5 mg | — |
| Subject | Solifenacin | Small molecule | 10 mg | — |