Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
120 participants
INTERVENTIONAL
2015-01-31
2019-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Outcome of the Transobturator Tape (TOT) Procedure
NCT01532583
Urethral Length and TOT (Transobturator Tape) Positioning
NCT01753011
A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence
NCT06232525
Transobturator Subtrigonal Tape vs Transobturator Suburethral Tape for Stress Urinary Incontinence
NCT02112591
Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI
NCT01392651
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TOT 8/4
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.
TOT 8/4
placement of transobturator sling according to the TOT 8/4 technique
TOT 6/3
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.
TOT 6/3
placement of transobturator sling according to the TOT 6/3 technique
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TOT 8/4
placement of transobturator sling according to the TOT 8/4 technique
TOT 6/3
placement of transobturator sling according to the TOT 6/3 technique
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Klinikum der Universität Köln
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Professor Dr. Wolfram Jäger
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wolfram Jager, Professor
Role: STUDY_DIRECTOR
Head of the Department of Urogyne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Obstetrics and Gynecology, University of Cologne
Cologne, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15-012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.