Clinical trial Recruiting at 1 site Interventional Ages 18 to 80 Women only

Pubo-urethral ligament plication versus transobturator tape for female stress urinary incontinence

Official title: 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

Run by Harran University · NCT07290114 · Data updated 2026-11-12

This compares a mesh-free repair (PLP) with a mesh-based mid-urethral sling (TOT) to see if women with stress urinary incontinence get similar continence and fewer complications.

More Stress Urinary Incontinence (SUI) trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexWomen only
Enrollment147 (estimated)
SponsorHarran University
Academic / other
Locations1 site (Şanliurfa, HALİLİYE)
StatusRecruiting
StartedJanuary 13, 2025
Main results expectedJune 2026
Study endsSeptember 2026
Registry record updatedDecember 18, 2025
Trial IDNCT07290114 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18–80 with clinically confirmed stress urinary incontinence who have tried conservative therapy and are choosing surgical treatment, able to consent and attend follow-up, are ideal candidates.

Probably not a fit

Women with predominant urge incontinence, pelvic organ prolapse stage II or greater, prior anti-incontinence surgery, active urinary infection, neurological bladder disease, or pregnancy plans may not benefit or are ineligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, comparative study enrolling women with clinically diagnosed stress urinary incontinence who elect surgical treatment. Patients and surgeons use shared decision-making to select either pubo-urethral ligament plication (PLP), a mesh-free native tissue repair, or transobturator tape (TOT), a mesh-based mid-urethral sling, and baseline and short-term outcomes are collected. The primary outcome is early continence improvement measured by validated tools (ICIQ-SF) and clinical exam, and secondary outcomes include operative time, hospital stay, postoperative pain, urinary retention, de novo urgency, wound complications, and patient satisfaction. Short-term follow-up visits capture perioperative and postoperative complications and patient-reported outcomes to compare effectiveness and safety profiles.

Why it matters

Potential benefit: If successful, PLP could provide a mesh-free surgical option with comparable continence results and fewer mesh-related complications for women seeking alternatives to synthetic implants.

How similar studies have gone: Mesh-based mid-urethral slings like TOT have a strong evidence base for effectiveness, while mesh-free native tissue repairs such as PLP have shown promising but less extensively validated results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Harran University Research and Application Hospital
    Şanliurfa, Hali̇li̇ye, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.