Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
RECRUITING
Van
Contact Information
Primary
Yusuf Başkıran, Doctor
yusuf.baskiran@istinye.edu.tr
+905419523468
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2025-11-12
Participants
Target number of participants: 106
Treatments
Experimental: 1.2 cm Mesh (Intervention Group)
Participants in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh.
Active_comparator: 1.0 cm Mesh (Control Group)
Participants in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which represents the standard procedure.
Sponsors
Leads: Izzet Celegen

This content was sourced from clinicaltrials.gov