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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Helsinki University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00379314
First received: September 19, 2006
Last updated: October 31, 2006
Last verified: September 2006
History of Changes

September 19, 2006
October 31, 2006
April 2004
Not Provided
  • Complications
  • Objective cure rate by stress test and pad weighing test
Same as current
Complete list of historical versions of study NCT00379314 on ClinicalTrials.gov Archive Site
Quality of life questionnaires
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Stress Incontinence
  • Procedure: TVT and TVT-O minimally invasive surgical procedures
  • Procedure: Surgery for female stress urinary incontinence
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
December 2010
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00379314
42/E8/04
Not Provided
Not Provided
Helsinki University
Not Provided
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