The Effect of an Additional TVT on OAB Symptoms in Surgical Repair of Pelvic Organ Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Overactive Bladder Questionnaire (OAB-q short form)
Study Overview
Brief 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).
Detailed Description
Hypothesis: Based on the limited data available, the investigators expect to find that there will be less improvement in OAB symptoms in women undergoing POP surgery with TVT than those undergoing POP surgery alone.
Primary Aim: To determine what effect the addition of a TVT will have on OAB symptoms in women undergoing surgical repair of pelvic organ prolapse using validated questionnaires.
Secondary Aims: To compare postoperative complications between those undergoing prolapse surgery alone and those undergoing prolapse surgery and TVT. Lastly the investigators would like to evaluate comorbidities and potential association to the degree of OAB symptoms
Methods:
Potential eligible subjects will be recruited using information provided by urogynecology staff and by reviewing the upcoming OR schedule. After subjects have been identified, the surgeon will be contacted to confirm whether or not their patient can be contacted by the research team. Only after permission has been communicated from the surgeon to the research team will the team approach the patient about potential participation.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Overactive Bladder Questionnaire (OAB-q short form)
Time Frame: baseline and 12 months
Change in the OAB-q score at 12 months as compared to baseline.
Secondary Outcomes
- UDI-6 change score(baseline and 12 months)