Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
Izzet Celegen
106 participants
May 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria9
- 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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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06924450