An interventional study of Transobturator Tape (TOT) Procedure and Tension-Free Vaginal Tape (TVT) Procedure in Stress Urinary Incontinence in Women and Pelvic Floor Disorders, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Treatment
Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Although these procedures are widely used, there is limited information comparing their short-term anatomical and patient-reported outcomes using imaging techniques.
The aim of this study is to compare the short-term anatomical and subjective outcomes of TOT, TVT, and Burch colposuspension in women with stress urinary incontinence. Transperineal ultrasonography will be used to assess anatomical changes before surgery and during follow-up. Patient-reported outcomes and clinical findings will also be evaluated.
The results of this study may help improve the understanding of surgical outcomes in stress urinary incontinence and support clinical decision-making.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's enrollment of 80 is above the median of 63 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants underwent mid-urethral sling surgery for the treatment of stress urinary incontinence.
Procedure: Transobturator Tape (TOT) Procedure
Participants in this arm underwent tension-free vaginal tape (TVT) surgery for the treatment of stress urinary incontinence.
Procedure: Tension-Free Vaginal Tape (TVT) Procedure
Participants in this arm underwent Burch colposuspension surgery for the treatment of stress urinary incontinence.
Procedure: Burch Colposuspension Procedure
Placement of a synthetic tape beneath the mid-urethra via the transobturator route.
Also known as: tot
Placement of a synthetic tape beneath the mid-urethra using a retropubic approach.
Suspension of the anterior vaginal wall to the iliopectineal (Cooper's) ligament using non-absorbable sutures.
Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound
The primary outcome is the change in urethrovesical and urethral angles measured by transperineal ultrasonography before surgery and at 3 months after surgery.
Time frame: Baseline (preoperative) and 3 months postoperatively
Subjective Improvement in Stress Urinary Incontinence Symptoms
Subjective outcomes were assessed using the Urogenital Distress Inventory-Short Form (UDI-6) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). For both scales, scores range from 0 to 100, where higher scores indicate a greater impact of symptoms and worse quality of life.
Time frame: Baseline and 3 months postoperatively
Comparison of Anatomical Outcomes Between Surgical Techniques
Anatomical outcomes assessed by transperineal ultrasonography were compared between the TOT, TVT, and Burch colposuspension groups.
Time frame: 3 months postoperatively
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Zeynep Kamil Maternity and Pediatric Research and Training Hospital