NCT06924450 Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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

Related Trials