Comparison of TOT 8/4 Versus TOT 6/3
URGE-III
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)
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedNovember 5, 2015
November 1, 2015
3.9 years
November 4, 2015
November 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distance between urethra and transobturator sling
transvaginal ultrasound measurements
2 weeks
Secondary Outcomes (1)
Distance between urethra and transobturator sling
16 weeks
Study Arms (2)
TOT 8/4
ACTIVE COMPARATORTransobturator 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.
TOT 6/3
EXPERIMENTALTransobturator 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.
Interventions
Eligibility Criteria
You may qualify if:
- urinary incontinence
You may not qualify if:
- previous TOT or TVT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology, University of Cologne
Cologne, North Rhine-Westphalia, 50931, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wolfram Jager, Professor
Head of the Department of Urogyne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 5, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2018
Study Completion
April 1, 2019
Last Updated
November 5, 2015
Record last verified: 2015-11