Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
NCT07290114

Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape

Led by Mehmet Incebıyik · Updated on 2025-12-18

147

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective clinical study aims to compare the short-term effectiveness, safety, and patient-reported outcomes of two surgical techniques used for the treatment of female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP), a mesh-free native tissue repair method, and the Transobturator Tape (TOT) procedure, a commonly used mesh-based mid-urethral sling technique. The study evaluates continence improvement, perioperative and postoperative complications, operative time, hospital stay, postoperative pain, and patient satisfaction. The goal is to provide evidence on whether a mesh-free surgical option such as PLP can offer comparable outcomes to mesh-based TOT, particularly for patients seeking alternatives to synthetic materials.

CONDITIONS

Official Title

Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 80 years
  • Clinical diagnosis of stress urinary incontinence
  • Failure of conservative management such as pelvic floor exercises or medical therapy
  • Desire to undergo surgical treatment with PLP or TOT
  • Ability to provide informed consent
  • Willingness to attend postoperative follow-up visits
Not Eligible

You will not qualify if you...

  • Mixed urinary incontinence with predominant urge symptoms
  • Active urinary tract infection
  • Pelvic organ prolapse stage II or higher
  • Previous anti-incontinence surgery
  • Neurological diseases affecting bladder function
  • Pregnancy or planning pregnancy during follow-up
  • Uncontrolled diabetes or bleeding disorders
  • Contraindications to surgery
  • Use of medications affecting bladder function such as anticholinergics
  • Inability to provide informed consent

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

Harran University Research and Application Hospital

Şanliurfa, HALİLİYE, Turkey (Türkiye), 63300

Actively Recruiting

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Research Team

M

Mehmet İNCEBIYIK, MD

CONTACT

Ö

Ömer TAMMO, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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