Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Stress incontinence
- Last Updated
- 11 years ago
Overview
Brief Summary
- To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence.
- Observe the immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure.
Detailed Description
The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure, when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects with occult stress incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse reduction and 1 hour pad test will also be compared between subjects with and without a concomitant TVT-O procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery
- •Bulge of paries anterior vaginas stage III-IV
- •Uterine prolapse stage II-II
- •Without symptoms of stress urinary incontinence
- •Screening tests of occult stress urinary incontinence(OSUI) should be positive
- •≥55 years old.
Exclusion Criteria
- •Pregnancy
- •Illegible to follow up after surgery
- •Previous surgery for stress urinary incontinence
- •Unfinished data collection before surgery
Outcomes
Primary Outcomes
Stress incontinence
Time Frame: 3 months to 2 years post-operation
Urine loss from physical activity such as coughing, sneezing or laughing.
Secondary Outcomes
- Immediate and short-term complications(Intraoperative and 2 years post-opeartion)
- Overall urinary tract function(3 months, 12 months and 2 years post-operation)