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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorMehmet Incebıyik

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Mixed urinary incontinence with predominant urge symptoms

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pubo-Urethral Ligament Plication (PLP)

    Procedure/Surgery

    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.

  • Transobturator Tape (TOT)

    Procedure/Surgery

    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.

Treatment groups

147 Participants
are divided into 2 treatment groups
Group A: PLP ArmExperimental treatment 1 intervention
Group B: TOT ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in Stress Urinary Incontinence Symptoms (ICIQ-SF Score)

Change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score from baseline to postoperative 6 weeks. Lower scores indicate improvement in symptom severity.

Time frame
6-24 weeks postoperatively

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Harran University Research and Application HospitalRecruiting63300, Şanliurfa, HALİLİYETurkey (Türkiye)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mehmet Incebıyik

Lead sponsor

Harran University

Sponsor institution