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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Complications
  • Objective cure rate by stress test and pad weighing test

Secondary Outcome Measures:
  • Quality of life questionnaires

Estimated Enrollment: 260
Study Start Date: April 2004
Estimated Study Completion Date: December 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379314

Locations
Finland
Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00379314     History of Changes
Other Study ID Numbers: 42/E8/04
Study First Received: September 19, 2006
Last Updated: October 31, 2006
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University:
Incontinence
Urinary
Female
Surgery
Complications

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 22, 2014