RecruitingNot ApplicableNCT07290114

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

Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape With Short-Term Patient-Centered Outcomes

Sponsor

Mehmet Incebıyik

Enrollment

147 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence (SUI)

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

Female patients aged 18-80 years
Clinical diagnosis of stress urinary incontinence
Failure of conservative management (pelvic floor exercises or medical therapy)
Desire to undergo surgical treatment (PLP or TOT)
Ability to provide informed consent
Willingness to attend postoperative follow-up visits

Exclusion Criteria9

Mixed urinary incontinence with predominant urge symptoms
Active urinary tract infection
Pelvic organ prolapse ≥ stage II
Previous anti-incontinence surgery
Neurological diseases affecting bladder function
Pregnancy or planning pregnancy during follow-up
Uncontrolled diabetes, bleeding disorders, or contraindications to surgery
Use of medications affecting bladder function (e.g., anticholinergics)
Inability to provide informed consent

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPubo-Urethral Ligament Plication (PLP)

A mesh-free native tissue surgical technique that reinforces urethral support by plicating the pubo-urethral ligament. The procedure aims to restore midurethral stability without the use of synthetic mesh.

PROCEDURETransobturator Tape (TOT)

A mesh-based midurethral sling procedure performed through the transobturator route to provide urethral support. The tape is positioned under the midurethra to treat stress urinary incontinence.