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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 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 40 participants.

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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).

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2015-05
Est. Completion 2017-06-30

What the Registry Record Tells You About NCT02502838

The ClinicalTrials.gov registry entry for NCT02502838 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02502838 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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