Stress Urinary Incontinence (SUI)PLP-TOTNCT07290114
Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape
A study testing Pubo-Urethral Ligament Plication (PLP) and Transobturator Tape (TOT) in people with Stress Urinary Incontinence (SUI), run by Mehmet Incebıyik at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Pubo-Urethral Ligament Plication (PLP) and Transobturator Tape (TOT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2025to Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Uncontrolled diabetes, bleeding disorders, or contraindications to surgery
- Use of medications affecting bladder function (e.g., anticholinergics)
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ömer TAMMO, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University Research and Application Hospital
Şanliurfa, HALİLİYE, 63300
MEHMET İNCEBIYIK, MD, +9005353374889, drmehmetincebiyik@gmail.com
drmehmetincebiyik@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Pubo-Urethral Ligament Plication (PLP), Transobturator Tape (TOT)
- Keywords
- Stress Urinary Incontinence, Pubo-Urethral Ligament Plication, PLP, Transobturator Tape, TOT, Mesh-free surgery, Midurethral sling
- Medical subject headings
- Urinary Incontinence, Stress, Pelizaeus-Merzbacher Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pubo-Urethral Ligament Plication (PLP)Procedure or 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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| PLP Arm | Experimental | 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. Receives: Procedure: Pubo-Urethral Ligament Plication (PLP) |
| TOT Arm | Active comparator | Patients undergoing the Transobturator Tape (TOT) procedure, a widely used mesh-based midurethral sling technique performed to provide urethral support via the transobturator route. Receives: Procedure: Transobturator Tape (TOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-24 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start13 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm prospective parallel comparison of mesh-free PLP versus mesh-based TOT surgical techniques.
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehmet Incebıyik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Incebıyik, Harran University
- Investigators
- MEHMET İNCEBIYIK, MD, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290114
- Sponsor's protocol ID
- HU-SUI-PLP-TOT-2025
- Acronym
- PLP-TOT
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided