Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06924450

Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

Led by Izzet Celegen · Updated on 2025-07-11

106

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older
  • Clinical diagnosis of stress urinary incontinence confirmed by positive stress test
  • Urethral hypermobility greater than 30 degrees confirmed by Q-tip test
  • Inadequate response to conservative therapy such as pelvic floor muscle training
  • Eligible for transobturator tape (TOT) surgery
  • Body mass index (BMI) less than 35 kg/m²
  • Able to provide informed consent and follow postoperative instructions
Not Eligible

You will not qualify if you...

  • History of prior midurethral sling surgery
  • Mixed urinary incontinence or urge-dominant symptoms
  • Pelvic organ prolapse stage greater than II according to POP-Q system
  • Neurological disorders affecting bladder function such as multiple sclerosis or spinal cord injury
  • Active urinary tract infection or recurrent urinary tract infections (3 or more in past 12 months)
  • Pregnant or planning to become pregnant within next 12 months
  • Severe comorbid conditions including uncontrolled diabetes, active malignancy, or pelvic radiotherapy
  • Use of medications that significantly affect bladder function such as anticholinergics or diuretics
  • Inability or unwillingness to attend follow-up visits or comply with postoperative care plan

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology

Van, Turkey (Türkiye), 65090

Actively Recruiting

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Research Team

Y

Yusuf Başkıran, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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