The Effect of an Additional Stress Incontinence Procedure on Overactive Bladder During Pelvic Organ Prolapse Repair

Completed

Conditions studied: Overactive Bladder, Pelvic Organ Prolapse

In brief

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).

Key facts

Study ID

NCT02502838

Run by

Icahn School of Medicine at Mount Sinai

People needed

40

Starts

2015-05-01

Expected to finish

2017-06-30

Last updated by the study team

2017-09-01

Who can join

Age: 22 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women >21 years old with stage 2 or greater pelvic organ prolapse who plan to undergo anterior and/or apical prolapse repair
• Women who respond affirmatively to questions 15 and 16 on the PFDI-20 questionnaire
• Women with negative urine culture pre-operatively
• Women able to provide informed consent

You may not qualify if…

• Women with pelvic organ prolapse that respond negatively to questions 15 and 16 on the PFDI-20 questionnaire
• Women with previous urogynecologic surgery including prior hysterectomy with any type of apical support known to the patient (history of hysterectomy alone may be included)
• Women who report UTI within 1 month of recruitment (with confirmation of positive culture)
• Women with history of diagnosis of interstitial cystitis or any treatment for interstitial cystitis
• Women who undergo TVT-O (transobturator) and not retropubic TVT
• Women who undergo posterior compartment repair only
• Women who are pregnant and up to 6 weeks postpartum
• Women who undergo prolapse repair with transvaginal mesh

Where it is running

• Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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