NCT06924450 Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
| NCT ID | NCT06924450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Izzet Celegen |
| Condition | Stress Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2025-11-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2025-05-12 with a primary completion date of 2025-11-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.
Eligibility Criteria
Inclusion Criteria: * Female patients aged 18 years or older * Clinical diagnosis of stress urinary incontinence (SUI), confirmed by: * Positive stress test (urine leakage on coughing with a comfortably full bladder) * Q-tip test showing urethral hypermobility (\>30 degrees) * Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy) * Eligible for transobturator tape (TOT) surgery * Body mass index (BMI) less than 35 kg/m² * Able to provide informed consent and follow postoperative instructions Exclusion Criteria: * History of prior midurethral sling surgery * Mixed urinary incontinence or urge-dominant symptoms * Pelvic organ prolapse stage \> II according to the POP-Q system * Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury) * Active urinary tract infection or recurrent UTI (defined as ≥3 infections within the past 12 months) * Pregnant or planning to become pregnant within the next 12 months * Severe comorbid conditions (e.g., uncontrolled diabetes mellitus, active malignancy, pelvic radiotherapy) * Use of medications that significantly affect bladder function (e.g., anticholinergics, diuretics) * Inability or unwillingness to attend follow-up visits or comply with postoperative care plan
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06924450 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06924450 currently recruiting?
Yes, NCT06924450 is actively recruiting participants. Contact the research team at yusuf.baskiran@istinye.edu.tr for enrollment information.
Where is the NCT06924450 trial being conducted?
This trial is being conducted at Van, Turkey (Türkiye).
Who is sponsoring the NCT06924450 clinical trial?
NCT06924450 is sponsored by Izzet Celegen. The trial plans to enroll 106 participants.