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Clinical Trials/NCT02598245
NCT02598245
Unknown
Not Applicable

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)

Klinikum der Universität Köln1 site in 1 country120 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Klinikum der Universität Köln
Enrollment
120
Locations
1
Primary Endpoint
Distance between urethra and transobturator sling
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
April 2019
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Klinikum der Universität Köln
Responsible Party
Principal Investigator
Principal Investigator

Professor Dr. Wolfram Jäger

Professor

Klinikum der Universität Köln

Eligibility Criteria

Inclusion Criteria

  • urinary incontinence

Exclusion Criteria

  • previous TOT or TVT

Outcomes

Primary Outcomes

Distance between urethra and transobturator sling

Time Frame: 2 weeks

transvaginal ultrasound measurements

Secondary Outcomes

  • Distance between urethra and transobturator sling(16 weeks)

Study Sites (1)

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