Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pubo-Urethral Ligament Plication (PLP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-24 weeks postoperatively |
Not provided
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet İNCEBIYIK, MD | Contact | +905353374889 | drmehmetincebiyik@gmail.com | |
| Ömer TAMMO, MD | Contact | drmehmetincebiyik@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MEHMET İNCEBIYIK, MD | Harran University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harran University Research and Application Hospital | Recruiting | Şanliurfa | HALİLİYE | 63300 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two-arm prospective parallel comparison of mesh-free PLP versus mesh-based TOT surgical techniques.
Not provided
Not provided
Not provided
Not provided
| Transobturator Tape (TOT) | Procedure | 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. |
|
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D020371 | Pelizaeus-Merzbacher Disease |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020279 | Hereditary Central Nervous System Demyelinating Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D056784 | Leukoencephalopathies |
| D003711 | Demyelinating Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided