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

December 4, 2025 updated by: Mehmet Incebıyik

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, prospective, comparative clinical study evaluating two established surgical interventions for female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP) and Transobturator Tape (TOT). PLP is a mesh-free native tissue repair technique that reinforces pubo-urethral support by plicating the periurethral tissues. TOT, a mesh-based mid-urethral sling procedure, provides support to the urethra through the placement of a synthetic tape via the transobturator route.

Eligible patients with a clinical diagnosis of SUI who elect to undergo surgical treatment will be allocated to one of the two interventions based on shared decision-making between the surgeon and the patient. The study will collect demographic data, operative parameters, perioperative complications, and short-term postoperative outcomes. Continence outcomes will be assessed using validated questionnaires such as the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), as well as objective clinical evaluation during follow-up visits. Pain levels, urinary retention, de-novo urgency, wound complications, and overall patient satisfaction will also be recorded.

The primary aim of the study is to compare early continence improvement between the PLP and TOT procedures. Secondary aims include comparing perioperative and postoperative complications, operative time, postoperative pain, hospital discharge time, and patient-reported satisfaction. By directly comparing a mesh-free native tissue technique with a commonly used mesh-based sling, this study seeks to provide updated, patient-centered data that may guide surgical decision-making, especially in settings where mesh-related concerns or patient preference favor native tissue repair options.

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLP Arm
Patients undergoing mesh-free Pubo-Urethral Ligament Plication (PLP), a native tissue surgical technique performed to reinforce urethral support without the use of synthetic mesh.
Procedure: Pubo-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.
Active Comparator: TOT Arm
Patients undergoing the Transobturator Tape (TOT) procedure, a widely used mesh-based midurethral sling technique performed to provide urethral support via the transobturator route.
Procedure: Transobturator 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Stress Urinary Incontinence Symptoms (ICIQ-SF Score)
Time Frame: 6-24 weeks postoperatively
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.
6-24 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehmet Incebıyik

Investigators

  • Principal Investigator: MEHMET İNCEBIYIK, MD, Harran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-SUI-PLP-TOT-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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