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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07290114
- Acronym / sponsor ID
- PLP-TOT / HU-SUI-PLP-TOT-2025
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Stress Urinary Incontinence, Pubo-Urethral Ligament Plication, PLP, Transobturator Tape, TOT, Mesh-free surgery, Midurethral sling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Mehmet IncebıyikUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm prospective parallel comparison of mesh-free PLP versus mesh-based TOT surgical techniques.
| Arm | Type | Receives |
|---|---|---|
| PLP Arm | Experimental | Procedure: Pubo-Urethral Ligament Plication (PLP)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. |
| TOT Arm | Active comparator | Procedure: Transobturator Tape (TOT)Patients undergoing the Transobturator Tape (TOT) procedure, a widely used mesh-based midurethral sling technique performed to provide urethral support via the transobturator route. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | PLP Arm |
| 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. | Procedure or surgery | TOT Arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ömer TAMMO, MD contact
MEHMET İNCEBIYIK, MD principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet İNCEBIYIK, MD (+905353374889, drmehmetincebiyik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Stress Urinary Incontinence Symptoms (ICIQ-SF Score) (time frame: 6-24 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.