NCT02598245

Comparison of TOT 8/4 Versus TOT 6/3

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Klinikum der Universität Köln · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	TOT 8/4	placement of transobturator sling according to the TOT 8/4 technique
DEVICE	TOT 6/3	placement of transobturator sling according to the TOT 6/3 technique

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-12-01
• Completion: 2019-04-01
• First posted: 2015-11-05
• Last updated: 2015-11-05

Locations

1 site across 1 country: Germany