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

Klinikum der Universität Köln

Status: Unknown

Conditions: Urinary Incontinence

Treatments: Device: TOT 6/3; Device: TOT 8/4

Study type: Interventional

Funder types: Other

Identifiers

NCT02598245

15-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• urinary incontinence

Exclusion criteria

• previous TOT or TVT

Trial design

120 participants in 2 patient groups

TOT 8/4

Active Comparator group

Description:

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.

Treatment:

Device: TOT 8/4

TOT 6/3

Experimental group

Description:

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.

Treatment:

Device: TOT 6/3