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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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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.

Conditions

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Pelvic Organ Prolapse Stress Urinary Incontinence Other Specified Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No TVT-O

Improved reconstruction pelvic surgery

Group Type ACTIVE_COMPARATOR

Improved reconstruction pelvic surgery

Intervention Type PROCEDURE

Repair of severe pelvic organ prolapse with mesh.

Combined surgery group

Improved reconstruction pelvic surgery TVT-O procedure

Group Type EXPERIMENTAL

TVT-O

Intervention Type PROCEDURE

Artificial mesh belt is placed in the middle urethra to provide support to remain no leak

Improved reconstruction pelvic surgery

Intervention Type PROCEDURE

Repair of severe pelvic organ prolapse with mesh.

Interventions

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TVT-O

Artificial mesh belt is placed in the middle urethra to provide support to remain no leak

Intervention Type PROCEDURE

Improved reconstruction pelvic surgery

Repair of severe pelvic organ prolapse with mesh.

Intervention Type PROCEDURE

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.