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Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

RecruitingNAAges 18 Years - anyFemaleIzzet Celegen
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • 1.2 cm Mesh TOT
  • 1.0 cm Mesh TOT
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Where

1 site
Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
Van, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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