Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success

Study Overview
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Brief Summary
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Transperineal ultrasonography is gaining importance in preoperative and postoperative evaluation of the patient with urinary incontinence with allowing well detailed information about the anterior compartment. There is little evidence that transperineal sonography can aid surgeons to predict the success or failure after mid-urethral slings. We aimed to investigate the efficacy of sonography in mini-sling operations to predict the success or failure.

Detailed Description
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Women who are scheduled for anti-incontinence operation due to their stress urinary incontinence will be pre- and postoperatively evaluated by transperineal and introital ultrasound. Patients will be followed for at least 1 year.

Official Title
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Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success

Conditions
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Urinary Incontinence,Stress

Intervention / Treatment
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* Diagnostic Test: Pelvic floor ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinically stress urinary incontinence Patients who claim that their condition severely impair their quality of life Patients who are failed on conservative management (life style changes and pelvic floor exercises) Exclusion Criteria: Patients who have unregulated diabetes mellitus (they will be included after appropriate and sustainable blood glucose regulation) Patients who have neurological condition that may affect the incontinence Patients who have psychiatric disease that may affect the subjective evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| participants<br>Patients who are scheduled for single-incision needleless (Contasure-needleless®) mini-sling for their stress urinary incontinence. They will be assessed by Pelvic floor ultrasound | Diagnostic Test: Pelvic floor ultrasound<br>* Pelvic floor ultrasound will include transperineal and introital ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation of failure with the sonographic features of the mesh | Patients will be accepted as failure if their stress test is positive Sonographic features of the mesh includes the shape of the mesh, the distance to the mid-urethra, the position related to the proximal urethra and the angle between the mesh arms on coronal axis | Evaluation at postoperative 1st and 4th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturia | The nocturia episodes will be evaluated by a non-validated Likert scale (between 0-3). Minimum and minimum scores are between 0 and 3. 0 will mean no episode of urinating during the sleep. 1 will mean one episode of nocturia. 2 will mean two episodes of nocturia. 3 will mean three or more episodes of nocturia. Higher values represent worse outcome. | Evaluation at postoperative 1st and 4th weeks and preoperatively | 
| Urge symptoms | Michigan Incontinence Severity Index (M-ISI) scale will be used to assess subjective outcome including urge symptoms. This scale has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for urge urinary incontinence [UUI], and items 7 and 8 for Pad usage [PU]. The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point). | Evaluation at postoperative 1st and 4th weeks and preoperatively | 
| Subjective success | Patient Global Improvement of Improvement will be used to assess the subjective success | Evaluation at postoperative 1st and 4th weeks | 
| POP-Q | POP-Q measurements will be assessed to measure the pelvic floor prolapse if exist | Evaluation at postoperative 1st and 4th weeks and preoperatively | 
| Anterior compartment mobility distances | On maximal Valsalva maneuver: Bladder neck descent (mm), pubourethral distance (mm), urethral thickness (mm, measured at proximal, mid and distal portions) and urethral length (mm) | Evaluation at postoperative 1st and 4th weeks and preoperatively | 
| Anterior compartment mobility angles | On maximal Valsalva maneuver: Proximal urethral rotation (degree), retrovesical angle (degree) | Evaluation at postoperative 1st and 4th weeks and preoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor ultrasonography, transperineal ultrasound, introital ultrasound, mini-sling, needleless, Urinary Incontinence,Stress