Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- To compare the postoperative prevalence of stress incontinence in patients with or without TOT implant during a pelvic organ prolapse surgery
Study Overview
Brief Summary
Nowadays the clinical significance of an occult stress urinary incontinence and its optimal treatment is not known.Regarding treatment, there are 2 main approaches : either the systematic preventive treatment of the occult stress urinary incontinence by means of a tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of prolapse in the first place and treatment of stress incontinence in a second time when and if it appears.This study is expected to provide objective evidence concerning the efficacy and security of TOT implantation for the prevention treatment of occult stress urinary incontinence in women with pelvic organ prolapse and occult urinary incontinence.The perspective is to improve the management of these patients by providing evidence based recommendation for their treatment.
Detailed Description
The study population consists of women with pelvic organ prolapse and occult stress urinary incontinence. They are randomised within two groups : one group with pelvic organ prolapse surgery alone and one group with implantation of TOT together with prolapse surgery for prevention of stress urinary incontinence.TOT implantation is performed as described previously, while the pelvic organ prolapse surgery could either be of abdominal (open or laparoscopic) or vaginal approach. Eighty eight (88) patients will be enrolled at 3 sites centers.
This study is a prospective, multicenter, randomised, active-control arm trial. The study population consists of women with pelvic organ prolapse and occult stress urinary incontinence. They are randomised within two groups : one group with pelvic organ prolapse surgery alone and one group with implantation of TOT together with prolapse surgery for prevention of stress urinary incontinence.TOT implantation is performed as described previously, while the pelvic organ prolapse surgery could either be of abdominal (open or laparoscopic) or vaginal approach. Eighty eight (88) patients will be enrolled at 3 sites centers.
Visit I (J-2 months +/- 1 month) :
During this visit the following will be performed :
- Collection of general medical, obstetric and surgical history of the patients
- Collection of incontinence, prolapse and sexual history with the following questionnaires :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients, at least 18 years of age
- •Having a pelvic organ prolapse and occult stress urinary incontinence
- •Patient non opposed to the exploitation of data in research
- •Agree to comply with all protocol-specified procedures, including protocol mandated follow up visits
Exclusion Criteria
- •Symptoms of stress urinary incontinence preoperatively
- •Patients not having social security
- •Pregnancy or lactation
Arms & Interventions
only surgery
Intervention: Pelvic Organ Prolapse intervention (Procedure)
surgery + TOT
Intervention: Pelvic Organ Prolapse and Suburethral TOT implantation (Procedure)
Outcomes
Primary Outcomes
To compare the postoperative prevalence of stress incontinence in patients with or without TOT implant during a pelvic organ prolapse surgery
Time Frame: 6 month
Secondary Outcomes
- To compare the severity of new onset overactive bladder between the two groups(6 month)
- To compare the prevalence of postoperative dyspareunia at 6 months between the two groups(6 month)
- To compare the prevalence of postoperative urinary retention between the two groups(6 month)
- To compare the severity of postoperative dyspareunia at 6 months between the two groups(6 month)
- To compare the prevalence of dyschesia and constipation at 6 months between the two groups(6 month)
- To compare the prevalence of new onset overactive bladder postoperatively between the two groups(6 month)
- To compare pre- and postoperative urodynamic test of patients when they are incontinent at 6 months(6 month)
- To compare the severity of postoperative stress urinary incontinence between the two groups(6 month)
- To compare the postoperative Patient Global Impression of Improvement and degree of satisfaction at 6 months between the 2 groups(6 month)