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Completed

NCT Number: NCT00308009

Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

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Key information

Conditions

Pelvic Organ Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urinary Stress Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.

Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -

Exclusion criteria

Not agreed to participate in randomization

-

Treatment and study plan

Vaginal Repair for prolapse, TVT procedure

Procedure
  • TVT at the time of Vaginal Repair
  • TVT 3 months after Vaginal Repair

Other names: Incontinence surgery, Mid-urethra sling, Prolapse surgery., Prolapse repair

TVT and Prolapse surgery

Procedure
  • TVT at the time of Prolapse surgery
  • TVT 3 months after Prolapse Surgery

Primary outcomes

  1. Any or no leakage of urine when coughing

    Time frame: 1 year

Secondary outcomes

  1. The cure of urinary stress incontinence (USI) by only prolapse surgery

    Time frame: 1 year

  2. Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Registry information

Official study title

Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Mar 28, 2006
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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