Urinary Incontinence Clinical Trial
— URGE-IIIOfficial 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)
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Germany | Department of Obstetrics and Gynecology, University of Cologne | Cologne | NRW |
Lead Sponsor | Collaborator |
---|---|
Klinikum der Universität Köln |
Germany,
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 |
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