Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial

Conditions
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Pelvic Organ Prolapse, Stress Urinary Incontinence, Other Specified Urinary Incontinence

Intervention / Treatment
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* Procedure: TVT-O
* Procedure: Improved reconstruction pelvic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No TVT-O<br>Improved reconstruction pelvic surgery | Procedure: Improved reconstruction pelvic surgery<br>* Repair of severe pelvic organ prolapse with mesh.<br>|
| Experimental: Combined surgery group<br>Improved reconstruction pelvic surgery TVT-O procedure | Procedure: TVT-O<br>* Artificial mesh belt is placed in the middle urethra to provide support to remain no leak<br>Procedure: Improved reconstruction pelvic surgery<br>* Repair of severe pelvic organ prolapse with mesh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress incontinence | Urine loss from physical activity such as coughing, sneezing or laughing. | 3 months to 2 years post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate and short-term complications | Immediate and short-term complications such as hemorrhage, bladder perforation and infection. | Intraoperative and 2 years post-opeartion | 
| Overall urinary tract function | Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test. | 3 months, 12 months and 2 years post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occult stress incontinence, Pelvic Organ Prolapse, Surgical Intervention, TVT-O(Tension-free vaginal tape-obturator), Improved Reconstructive Pelvic Surgery, Combined Surgery, Two-step Approach, Prophylactic Incontinence Procedure, Randomized Controlled Trial