Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

Launched by IZZET CELEGEN · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the width of a special mesh used in surgery affects the success of treating stress urinary incontinence (SUI) in women. Stress urinary incontinence is a condition where women leak urine during activities like coughing, sneezing, or exercising. The trial compares two different widths of mesh—1.2 cm and 1 cm—to see which one leads to better healing and fewer complications after surgery. Researchers will track how well the surgery works over a year, including how much the symptoms improve and how satisfied the patients feel with the results.

To participate in this trial, women must be at least 18 years old and have experienced stress urinary incontinence despite trying other treatments, like pelvic floor exercises. They should be planning to undergo transobturator tape (TOT) surgery and have a body mass index (BMI) under 35. Participants will receive care and follow-up visits to monitor their recovery. It's important to note that women with certain conditions, like previous related surgeries or significant bladder issues, may not be eligible for this study. Overall, this trial aims to find out if using a wider mesh can improve surgical outcomes for women dealing with this challenging condition.

Gender

FEMALE

Eligibility 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