Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse
Public ClinicalTrials.gov record NCT01092624. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Placebo-Controlled Parallel-Design Trial of the Effect of Solifenacin Treatment for Overactive Bladder in Women With Anterior Vaginal Wall Prolapse Managed With a Pessary (the "PESSARY" Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01092624
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 94 participants
Conditions and interventions
Conditions
Interventions
- Solifenacin Drug
- Placebo Drug
- Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2010
- Primary completion
- Sep 30, 2011
- Completion
- Sep 30, 2011
- Last update posted
- Nov 3, 2011
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01092624, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2011 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01092624 live on ClinicalTrials.gov.