Comparison of TOT 8/4 Versus TOT 6/3 (URGE-III)

November 4, 2015 updated by: Professor Dr. Wolfram Jäger, Klinikum der Universität Köln

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50931
        • Recruiting
        • Department of Obstetrics and Gynecology, University of Cologne
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • urinary incontinence

Exclusion Criteria:

  • previous TOT or TVT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: TOT 8/4
placement of transobturator sling according to the TOT 8/4 technique
Experimental: 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.
Device: TOT 6/3
placement of transobturator sling according to the TOT 6/3 technique

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum der Universität Köln

Investigators

  • Study Director: Wolfram Jager, Professor, Head of the Department of Urogyne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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