Trials / Unknown
UnknownNCT02193607
Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients
Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- Female
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
1. 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. 2. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TVT-O | Artificial mesh belt is placed in the middle urethra to provide support to remain no leak |
| PROCEDURE | Improved reconstruction pelvic surgery | Repair of severe pelvic organ prolapse with mesh. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2016-01-01
- Completion
- 2017-01-01
- First posted
- 2014-07-17
- Last updated
- 2014-07-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02193607. Inclusion in this directory is not an endorsement.