Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure

Study Overview
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Brief Summary
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This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISSTTM). Study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

Detailed Description
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The single-incision midurethral sling (SIMUS) is a procedure where there are no exit incisions. There is a 15 mm suburethral incision with the sling being attached with anchors to the obturator muscle on each side. This procedure has potentially lesser side-effects compared to the longer slings however, the literature has not found the SIMUS to be as effective as the long slings. In our recently published study, the DISSTTM technique has significantly improved the success of the SIMUS procedure as the sling can be tested for proper application in vivo. As we have performed several of these procedures in the operating room entirely under local anesthesia, we have decided to perform this procedure in an office setting using the same safety precautions as in a hospital operating room. Performing this procedure in the office has significant benefits for the patient, the healthcare industry, and the economy overall. Moving away from a hospital setting has significant psychological benefits. This will increase patient acceptance and therefore will become appealing to many more women who may be shying away from treatment. It would also eliminate the risk of nosocomial infections for the patient and family members, improve efficiency as the wait time would be negligible, and would reduce the expense of the entire treatment as hospital costs would not feature in the equation. This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISSTTM). Study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

Official Title
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Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Single-Incision Sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SUI with hypermobility of the urethrovesical (UV) junction American Society of Anesthesiologists (ASA) classes I or II Ages ranging 21-89 years Have the ability to stand for CST during the procedure Have failed behavioral therapy Exclusion Criteria: Patient has not completed childbearing ASA classes III or IV Need for concomitant surgery Poor compliance for office-based approach

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Incision Sling<br>Intervention with in office solyx suburethral sling DISST | Device: Single-Incision Sling<br>* Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.<br>* Other names: Solyx Single-incision sling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) | Subject tolerability will be assessed using a 10-cm visual analogue scale rating tolerability of the procedure. | intraoperative | 
| Surgeon difficulty of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) | Surgeon difficulty will be determined by a 5-point Likert scale | intraoperative | 
| The feasibility and success of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) | The primary objective of this study is to assess the feasibility and success of performing the Solyx SIMUS procedure in the office setting using the DISST technique . DISST Success will be defined as a negative intraoperative standing cough stress test (CST) at bladder fullness. | intraoperative | 
| Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) | Any intraoperative complications will be documented | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite success in correcting stress urinary incontinence | Secondary outcome objectives will be composite success in correcting SUI, and this will be determined based upon subjective data from the questionnaire Patient Global Impression of Improvement (PGI-I) and objective data (standing cough stress test) | 3, 6 and 12 months post operative | 
| Improvement in overall urinary incontinence (stress and urge incontinence) | Subject will complete MESA questionnaire to assess improvement in urge incontinence and stress incontinence | 6 and 12 months3, 6 and 12 months post operative | 
| Sexual function | Subject will complete PISQ-12 questionnaire to assess changes in sexual function. | 3, 6 and 12 months post operative | 
| Improvement in patient quality of life as it relates to urinary symptoms | Subject will complete IIQ-7 questionnaire to assess changes is quality of life related to urinary symptoms. | 3, 6 and 12 months post operative | 
| Subject satisfaction with overall improvement from sling procedure | Subject will completed satisfaction questionnaire to determine patients overall satisfaction with the procedure and results | 3, 6 and 12 months post operative | 
| Post operative pain | Post operative pain will be assessed using a McCarthy pain scale questionnaire. This will be completed prior to surgery, the day of, and the 7 days following surgery. | pre-procedure to 7 days after procedure | 
| Post operative complications | At post operative visits patients will be asked and assessed for post operative complications | post procedure to 12 months |