ClinicalTrials.Veeva

Menu

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 logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems