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NCT01092624 · ClinicalTrials.gov registry record · Phase 4
Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse
A Phase 4 study, sponsored by Hartford Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 94
- Enrollment target
NCT01092624: Clinical Trial Phase 4 study, sponsored by Hartford Hospital.
NCT01092624 is a Phase 4 study that was terminated before completion, run by Hartford Hospital. The registered enrollment target is 94 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01092624, a Phase 4 study, was terminated before completion, sponsored by Hartford Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 94 participants
- Enrollment target
Study 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.
Primary Outcome
Using the PFDI and PFIQ and a standardized medication response questionnaire to assess each subject's response to either the placebo or the solinefacin at Week 6 and Week 14, we will evaluate the effect of these therapies on subjects' bladder symptoms over the course of the study.
Interventions
- DRUG Placebo
- DRUG Solifenacin
- DEVICE Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 4 |
Why NCT01092624 stopped before completion
NCT01092624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01092624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01092624 about?
NCT01092624 is a clinical study titled "Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse". 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 pr...
What is the current status of trial NCT01092624?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 94 participants. The study started on 2010-03. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01092624?
The interventions under investigation include: Placebo (DRUG), Solifenacin (DRUG), Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex (DEVICE).
Who is sponsoring clinical trial NCT01092624?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01092624's enrollment target sits among peer trials
94 871st of 2000 higher than 1,127 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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