MedTrace Logo

Comparison of TOT 8/4 Versus TOT 6/3

NCT02598245 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-11-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Klinikum der Universität Köln

    lead OTHER

Principal Investigators

  • Wolfram Jager, Professor · Head of the Department of Urogyne

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-12-31
Completion
2019-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02598245 on ClinicalTrials.gov