Evaluating the impact of different mesh widths in surgery for urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a single-blind, randomized controlled trial that investigates the effect of two different widths of surgical mesh used in transobturator tape (TOT) surgery for women suffering from stress urinary incontinence (SUI). Participants will be randomly assigned to receive either a 1.2 cm mesh or a 1.0 cm mesh, with the aim of determining if the wider mesh leads to improved surgical outcomes, including better urinary control and fewer complications. The study will follow participants for one year, assessing cure rates, symptom improvement, and patient satisfaction through structured evaluations. The procedures will be standardized and conducted by an experienced surgeon to ensure consistency in the approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
  Van, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Yusuf Başkıran, Doctor
• Email: yusuf.baskiran@istinye.edu.tr
• Phone: +905419523468

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.