Health Trials

About this trial

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 criteria

Qualifiers

Female patients aged 18 years or older

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • 1.2 cm Mesh TOT
  • 1.0 cm Mesh TOT

Treatment groups

106 Participants
are divided into 2 treatment groups

Locations

1
Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology65090, Van Turkey (Türkiye)

Sponsors and collaborators

Izzet Celegen

Lead sponsor

Yuzuncu Yil University

Sponsor institution

Source ClinicalTrials.gov