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Retropubic vs. Transobturator Tension-free Vaginal Tape

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ClinicalTrials.gov Identifier: NCT00441454
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Karl Tamussino, MD, Austrian Urogynecology Working Group (AUWG)

Brief Summary:

The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone.

The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.


Condition or disease Intervention/treatment
Stress Urinary Incontinence Device: Transobturator Tension-free vaginal tape (TVT-O) Device: Retropubic Tension-free vaginal tape (TVT)

Detailed Description:
After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial
Study Start Date : September 2004
Primary Completion Date : June 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Retropubic Tension-free Vaginal Tape (TVT)
Device: Retropubic Tension-free vaginal tape (TVT)
Retropubic Tension-free vaginal tape (TVT)
Active Comparator: B
Transobturator Tension-free Vaginal Tape (TVT-O)
Device: Transobturator Tension-free vaginal tape (TVT-O)
tension-free vaginal tape (TVT)



Primary Outcome Measures :
  1. Continence [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 5 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
  • Patient able and willing to participate in follow-up
  • Informed consent

Exclusion Criteria:´

  • Detrusor overactivity, predominant complaint overactive bladder (OAB)
  • Major concomitant surgery
  • Prolapse beyond introitus or any prolapse necessitating surgery
  • Previous incontinence surgery other than colporrhaphy
  • Residual urine >100 ml
  • Neurologic disease
  • Allergy to local anesthetic agents
  • Coagulation disorders

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 ClinicalTrials.gov identifier (NCT number): NCT00441454


Locations
Austria
Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder
Graz, Austria, 8020
Department of OB/GYN, Medical University of Graz
Graz, Austria, 8036
Dept. OB/GYN, Medical University of Vienna
Vienna, Austria, 1090
Dept. OB/GYN, Wilhelminenspital
Vienna, Austria, 1160
Sponsors and Collaborators
Austrian Urogynecology Working Group (AUWG)
Investigators
Principal Investigator: Karl F Tamussino, MD Medical University of Graz, Dept. OB/GYN

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karl Tamussino, MD, PI, Austrian Urogynecology Working Group (AUWG)
ClinicalTrials.gov Identifier: NCT00441454     History of Changes
Other Study ID Numbers: TVT vs. TVT-O
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Karl Tamussino, MD, Austrian Urogynecology Working Group (AUWG):
stress urinary incontinence
surgery
tension-free vaginal tape
retropubic
transobturator
quality-of-life

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