1.2 cm Mesh TOT: Patients in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. The modified mesh width is being evaluated for its effect on surgical success, symptom improvement, and postoperative complications.
1.0 cm Mesh TOT: Patients in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which is the standard procedure. This group serves as a comparator to assess the impact of the modified mesh width.
Study 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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Objective Cure Rate Based on Negative Stress Test — 6 months postoperatively Objective cure will be defined as the absence of urinary leakage during a standardized cough stress test with a comfortably full bladder. The test will be performed by a blinded assessor at 6 months postoperatively.
Trial sites (1)
Facility
City
Region
Status
Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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