Comparison of TOT 8/4 Versus TOT 6/3

Urinary Incontinence Clinical Trial

— URGE-III  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598245
• Other study ID #: 15-012
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2015
• Last updated: November 4, 2015
• Start date: January 2015
• Est. completion date: April 2019

Study information

• Verified date: November 2015
• Source: Klinikum der Universität Köln
• Contact: Sebastian Ludwig, MD
• Phone: +49 221 478
• Email: sebastian.ludwig[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• urinary incontinence

Exclusion Criteria:

• previous TOT or TVT

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• TOT 8/4
placement of transobturator sling according to the TOT 8/4 technique
• TOT 6/3
placement of transobturator sling according to the TOT 6/3 technique

Locations

Country	Name	City	State
Germany	Department of Obstetrics and Gynecology, University of Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universität Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance between urethra and transobturator sling	transvaginal ultrasound measurements	2 weeks	No
Secondary	Distance between urethra and transobturator sling	transvaginal ultrasound measurements	16 weeks	No