Retropubic vs. Transobturator Tension-free Vaginal Tape

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Transobturator Tension-free vaginal tape (TVT-O)
* Device: Retropubic Tension-free vaginal tape (TVT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Retropubic Tension-free Vaginal Tape (TVT) | Device: Retropubic Tension-free vaginal tape (TVT)<br>* Retropubic Tension-free vaginal tape (TVT)<br>|
| Active Comparator: B<br>Transobturator Tension-free Vaginal Tape (TVT-O) | Device: Transobturator Tension-free vaginal tape (TVT-O)<br>* tension-free vaginal tape (TVT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, stress urinary incontinence, tension-free vaginal tape, retropubic, transobturator, quality-of-life