Comparison of TOT 8/4 Versus TOT 6/3

Not Applicable

• Conditions: Urinary Incontinence
• Interventions: Device: TOT 8/4; Device: TOT 6/3

• Registration Number: NCT02598245
• Lead Sponsor: Klinikum der Universität Köln

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-11
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Last Update Submitted: 2015-11-04
• Study First Posted: 2015-11-05
• Last Update Posted: 2015-11-05
• Primary Completion: 2018-12
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• urinary incontinence

Exclusion Criteria

• previous TOT or TVT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOT 8/4	TOT 8/4	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.
TOT 6/3	TOT 6/3	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.

Primary Outcome Measures

Name	Time	Method
Distance between urethra and transobturator sling	2 weeks	transvaginal ultrasound measurements

Secondary Outcome Measures

Name	Time	Method
Distance between urethra and transobturator sling	16 weeks	transvaginal ultrasound measurements

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Cologne; 🇩🇪 Cologne, NRW, Germany