Evaluating the impact of different mesh widths in surgery for urinary incontinence
Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
This study is testing whether using a wider surgical mesh during surgery for urinary incontinence in women can lead to better results and fewer problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yuzuncu Yil University Academic / other |
| Locations | 1 site (Van) |
| Trial ID | NCT06924450 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 years or older with a clinical diagnosis of stress urinary incontinence who have not responded adequately to conservative therapies.
Not a fit: Patients with mixed urinary incontinence, prior midurethral sling surgery, or significant pelvic organ prolapse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for women suffering from stress urinary incontinence.
How similar studies have performed: Other studies have explored various surgical techniques for urinary incontinence, but this specific comparison of mesh widths is novel.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 this trial is running
Van
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.