Actively Recruiting
Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
Led by Izzet Celegen · Updated on 2025-07-11
106
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using a wider surgical tape (mesh) in transobturator tape (TOT) surgery improves outcomes for women with stress urinary incontinence (SUI). This randomized controlled trial compares a 1.2 cm wide mesh (new method) to the standard 1.0 cm mesh. The study aims to determine if the wider mesh improves urinary control and reduces complications, with participants followed for one year. Participants will be randomly assigned to receive TOT surgery using either the 1.2 cm or 1.0 cm monofilament polypropylene mesh. All surgeries will be performed by one experienced surgeon using the same surgical technique, anesthesia, and care protocols to ensure consistency. Follow-up visits are planned at 1 week, 1 month, and 1 year after surgery, with evaluations by a blinded assessor. During the study, participants will have their urinary leakage tested and complete symptom questionnaires. Researchers will measure the primary outcome of objective cure through a negative stress test at 6 months. Secondary outcomes include symptom improvement, mesh-related complications like erosion or infection, recurrence of urinary incontinence, and patient satisfaction. The goal is to see if the modified mesh provides better support and fewer issues than the standard mesh.
CONDITIONS
Brief Title
Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Clinical diagnosis of stress urinary incontinence confirmed by a positive stress test
- Urethral hypermobility shown by Q-tip test (>30 degrees)
- Inadequate response to conservative therapy like pelvic floor muscle training or behavioral therapy
- Eligible for transobturator tape surgery
- Body mass index (BMI) less than 35 kg/m²
- Able to provide informed consent and follow postoperative instructions
You will not qualify if you...
- History of prior midurethral sling surgery
- Mixed urinary incontinence or urge-dominant symptoms
- Pelvic organ prolapse stage greater than II according to the POP-Q system
- Neurological disorders affecting bladder function such as multiple sclerosis or spinal cord injury
- Active urinary tract infection or recurrent UTI (3 or more infections in the past 12 months)
- Pregnant or planning to become pregnant within the next 12 months
- Severe comorbid conditions like uncontrolled diabetes, active cancer, or pelvic radiotherapy
- Use of medications that significantly affect bladder function such as anticholinergics or diuretics
- Inability or unwillingness to attend follow-up visits or comply with postoperative care plan
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo transobturator tape (TOT) surgery using either a 1.2 cm or 1.0 cm monofilament polypropylene mesh. Surgical technique, anesthesia, and perioperative management are standardized.
1 surgical visit (in-person)
Duration - 1 year
Participants attend postoperative visits for assessment of surgical success, symptom improvement, mesh-related complications, and patient satisfaction.
Visits at 1 week, 1 month, and 1 year (all in-person)
Trial Site Locations
Total: 1 location
1
Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
Van, Turkey (Türkiye), 65090
Actively Recruiting
Research Team
Y
Yusuf Başkıran, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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