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NCT02502838 · ClinicalTrials.gov registry record
The Effect of an Additional Stress Incontinence Procedure on Overactive Bladder During Pelvic Organ Prolapse Repair
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 40
- Enrollment target
NCT02502838: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02502838 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02502838 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
Pelvic organ prolapse (POP) is a common condition in women. Approximately 20% of women undergo surgical correction for POP in their lifetime. Overactive bladder symptoms (OAB) are often associated with POP in 25-69% of patients and POP has been shown to be an independent risk factor for OAB. There is scientific evidence that surgical repair of POP reduces or eliminates OAB in \>85%. In addition, stress urinary incontinence (SUI) is also often associated with POP, either clinically evident or as a potential post-operative complication. The clinical decision as to include a surgical technique to treat SUI when repairing POP surgically is still a matter of controversy. Most surgeons at the institution will include an extra procedure, specifically a retropubic sling, if SUI is clinically evident. Some will not include it unless there is urodynamic or clinical evidence of potential SUI post-operatively. Finally, some will include it regardless of clinical or urodynamic findings based on the apparent high incidence of such SUI after prolapse repair. The Tension-Free-Vaginal Tape (TVT) has been observed to reduce OAB as well as produce de-novo OAB symptoms, so the effect of TVT on OAB is still unclear. The purpose of this study is to determine the effect of additional TVT surgery on OAB symptoms in patients undergoing POP repair. It is hoped that such data will better determine the effect of either surgical intervention strategy on OAB symptoms. This is a prospective cohort study comparing patients with OAB that undergo surgical repair of their prolapse with or without additional TVT surgery. The outcomes will be measured using pre- and post-operative validated questionnaires (PFDI-20, OAB-q short form).
Primary Outcome
Change in the OAB-q score at 6 weeks as compared to baseline. The OAB-q short form is a validated questionnaire which includes a 6-item symptoms bother scale (OAB-q ss) and a 13-item HRQL scale (OAB-q HRQL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-05 |
| Est. Completion | 2017-06-30 |
What the finished NCT02502838 record still lists
NCT02502838 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02502838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02502838 about?
NCT02502838 is a clinical study titled "The Effect of an Additional Stress Incontinence Procedure on Overactive Bladder During Pelvic Organ Prolapse Repair". Pelvic organ prolapse (POP) is a common condition in women. Approximately 20% of women undergo surgical correction for POP in their lifetime. Overactive bladder symptoms (OAB) are often associated with POP in 25-69% of patients and POP has been shown to be an independent risk factor for OAB. There i...
What is the current status of trial NCT02502838?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2015-05. Estimated completion is 2017-06-30.
Who is sponsoring clinical trial NCT02502838?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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