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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02598245
Acronym
URGE-III
Enrollment
120
Registered
2015-11-05
Start date
2015-01-31
Completion date
2019-04-30
Last updated
2015-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

urinary incontinence, CESA, VASA, TOT, TVT

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.

Interventions

DEVICETOT 8/4

placement of transobturator sling according to the TOT 8/4 technique

DEVICETOT 6/3

placement of transobturator sling according to the TOT 6/3 technique

Sponsors

Klinikum der Universität Köln
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* urinary incontinence

Exclusion criteria

* previous TOT or TVT

Design outcomes

Primary

MeasureTime frameDescription
Distance between urethra and transobturator sling2 weekstransvaginal ultrasound measurements

Secondary

MeasureTime frameDescription
Distance between urethra and transobturator sling16 weekstransvaginal ultrasound measurements

Countries

Germany

Contacts

Primary ContactSebastian Ludwig, MD
sebastian.ludwig@uk-koeln.de+49 221 478
Backup ContactWolfram Jager, Professor
wolfram.jaeger@uk-koeln.de+49 221 478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026