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 Helsinki University.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2006
Last Update Posted : November 1, 2006
Information provided by:
Helsinki University

September 19, 2006
September 21, 2006
November 1, 2006
April 2004
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  • Complications
  • Objective cure rate by stress test and pad weighing test
Same as current
Complete list of historical versions of study NCT00379314 on Archive Site
Quality of life questionnaires
Same as current
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Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence
A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
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.
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Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Stress Incontinence
  • Procedure: TVT and TVT-O minimally invasive surgical procedures
  • Procedure: Surgery for female stress urinary incontinence
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2010
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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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Helsinki University
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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 Helsinki University
Helsinki University
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP