Comparison of TOT 8/4 Versus TOT 6/3

Study Overview
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Brief Summary
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Transobturator tapes (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.

Detailed Description
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Retrospective studies demonstrated that the distance between urethra and suburethral sling can vary considerably between 1 mm and 10 mm. In order to standardize the placement of the suburethral sling we choose two different distances between urethra and sling. Transobturator tape (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final fixation of the sling and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed. According to the used Hegar dilator sounds two different techniques are used: TOT 8/4 or TOT 6/3.

Official Title
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Comparison of the Distance Between the Transobturator Tape (TOT) and the Urethra According to Two Different Placement Techniques of the Tape (TOT 8/4 vs TOT 6/3)

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: TOT 8/4
* Device: TOT 6/3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: urinary incontinence Exclusion Criteria: previous TOT or TVT
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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TOT 8/4<br>Transobturator sling (TOT) is placed according to the original description. Instead of a Metzenbaum Scissor which should guarantee the distance between the urethra and the sling a Hegar dilator sound of 4 mm diameter is used (Hegar 4). An additional Hegar dilator sound of 8 mm is placed in the urethra before tightening the sling and suturing the vaginal skin. | Device: TOT 8/4<br>* placement of transobturator sling according to the TOT 8/4 technique<br>|
| Experimental: TOT 6/3<br>Transobturator sling (TOT) is placed according to the original description. Instead of a Metzenbaum Scissor which should guarantee the distance between the urethra and the sling a Hegar dilator sound of 3 mm diameter is used (Hegar 3). An additional Hegar dilator Sound of 6 mm is placed in the urethra before tightening the sling and suturing the vaginal skin. | Device: TOT 6/3<br>* placement of transobturator sling according to the TOT 6/3 technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance between urethra and transobturator sling | transvaginal ultrasound measurements | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance between urethra and transobturator sling | transvaginal ultrasound measurements | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, CESA, VASA, TOT, TVT