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

NCT02193607 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2014-07-17

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse
  • Stress Urinary Incontinence
  • Other Specified Urinary Incontinence

Interventions

PROCEDURE

TVT-O

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

PROCEDURE

Improved reconstruction pelvic surgery

Repair of severe pelvic organ prolapse with mesh.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Lan Zhu, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193607 on ClinicalTrials.gov