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Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379314
Recruitment Status : Unknown
Verified September 2006 by University of Helsinki.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2006
Last Update Posted : November 1, 2006
Information provided by:
University of Helsinki

Brief Summary:
The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Procedure: TVT and TVT-O minimally invasive surgical procedures Procedure: Surgery for female stress urinary incontinence Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
Study Start Date : April 2004
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Complications
  2. Objective cure rate by stress test and pad weighing test

Secondary Outcome Measures :
  1. Quality of life questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • history of stress incontinence
  • indications for surgical treatment
  • positive cough stress test
  • urgency score < 7

Exclusion Criteria:

  • prior incontinence surgery
  • need of concomitant surgery
  • post void residual urine volume < 100 ml
  • urinary tract anomalies
  • urinary tract infection
  • more than 3 urinary tract infection within last year
  • more than grade 2 urogenital prolapse
  • Body mass index > 35
  • Radiotherapy of the pelvic region
  • active malignancy
  • hemophilia
  • anticoagulant treatment
  • neurological disorder or other disease which affects bladder function
  • anticholinergic treatment
  • use of duloxetine
  • do not understand the purpose of the trial
  • immobility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379314

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Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
University of Helsinki
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Principal Investigator: Carl G Nilsson, MD,PhD Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Principal Investigator: Carl G Nilsson, MD,PhD University of Helsinki
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00379314    
Other Study ID Numbers: 42/E8/04
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: November 1, 2006
Last Verified: September 2006
Keywords provided by University of Helsinki:
Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations