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

N/AUnknownNCT02193607

Peking Union Medical College Hospital196 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

196

Conditions

Pelvic Organ Prolapse Stress Urinary Incontinence

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Stress incontinence

Urine loss from physical activity such as coughing, sneezing or laughing.

Time frame: 3 months to 2 years post-operation

Secondary Outcomes

Immediate and short-term complications

Immediate and short-term complications such as hemorrhage, bladder perforation and infection.

Time frame: 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.

Time frame: 3 months, 12 months and 2 years post-operation