Status:
RECRUITING
Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
Lead Sponsor:
Izzet Celegen
Conditions:
Stress Urinary Incontinence
Female Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 wome...
Detailed Description
This is a prospective, single-blind, randomized controlled trial evaluating the effect of mesh width on surgical outcomes in transobturator tape (TOT) procedures for women with stress urinary incontin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 12 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06924450
Start Date
May 12 2025
End Date
November 12 2025
Last Update
July 11 2025
Active Locations (1)
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1
Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
Van, Turkey (Türkiye), 65090