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

Not Applicable

• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence; Other Specified Urinary Incontinence
• Interventions: Procedure: TVT-O; Procedure: Improved reconstruction pelvic surgery

• Registration Number: NCT02193607
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-19
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-17
• Last Update Posted: 2014-07-17
• Primary Completion: 2016-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined surgery group	Improved reconstruction pelvic surgery	Improved reconstruction pelvic surgery TVT-O procedure
No TVT-O	Improved reconstruction pelvic surgery	Improved reconstruction pelvic surgery
Combined surgery group	TVT-O	Improved reconstruction pelvic surgery TVT-O procedure

Primary Outcome Measures

Name	Time	Method
Stress incontinence	3 months to 2 years post-operation	Urine loss from physical activity such as coughing, sneezing or laughing.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Obstetrics and Gynecology Department, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China