RecruitingNot ApplicableNCT06924450

Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

Sponsor

Izzet Celegen

Enrollment

106 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence Pelvic Floor Dysfunction Female Urinary Incontinence

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 women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 1.0 cm Mesh TOT and a medical device called 1.2 cm Mesh TOT for people with female urinary incontinence, pelvic floor dysfunction, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE1.2 cm Mesh TOT

Patients in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. The modified mesh width is being evaluated for its effect on surgical success, symptom improvement, and postoperative complications.

DEVICE1.0 cm Mesh TOT

Patients in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which is the standard procedure. This group serves as a comparator to assess the impact of the modified mesh width.