Retropubic vs. Transobturator Tension-free Vaginal Tape

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Retropubic Tension-free vaginal tape (TVT); Device: Transobturator Tension-free vaginal tape (TVT-O)

• Registration Number: NCT00441454
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-01
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-09
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 564

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

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• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Retropubic Tension-free vaginal tape (TVT)	Retropubic Tension-free Vaginal Tape (TVT)
B	Transobturator Tension-free vaginal tape (TVT-O)	Transobturator Tension-free Vaginal Tape (TVT-O)

Primary Outcome Measures

Name	Time	Method
Continence	5 years

Secondary Outcome Measures

Name	Time	Method
Quality of life	5 years

Trial Locations

Locations (4)

Dept. OB/GYN, Wilhelminenspital; 🇦🇹 Vienna, Austria

Dept. of Gynecology, Krankenhaus der Barmherzigen Brüder; 🇦🇹 Graz, Austria

Department of OB/GYN, Medical University of Graz; 🇦🇹 Graz, Austria

Dept. OB/GYN, Medical University of Vienna; 🇦🇹 Vienna, Austria