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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Stress Urinary Incontinence; Pelvic Organ Prolapse; Other Specified Urinary Incontinence

Treatments: Procedure: TVT-O; Procedure: Improved reconstruction pelvic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02193607

PTOS-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

No TVT-O

Active Comparator group

Description:

Improved reconstruction pelvic surgery

Treatment:

Procedure: Improved reconstruction pelvic surgery

Combined surgery group

Experimental group

Description:

Improved reconstruction pelvic surgery TVT-O procedure

Treatment:

Procedure: TVT-O

Procedure: Improved reconstruction pelvic surgery