Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Single-Incision Sling Intervention with in office solyx suburethral sling DISST |
Device: Single-Incision Sling
Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]
Subject tolerability will be assessed using a 10-cm visual analogue scale rating tolerability of the procedure.
- Surgeon difficulty of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]
Surgeon difficulty will be determined by a 5-point Likert scale
- The feasibility and success of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]
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.
- Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST) [intraoperative]
Any intraoperative complications will be documented
Secondary Outcome Measures
- Composite success in correcting stress urinary incontinence [3, 6 and 12 months post operative]
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)
- Improvement in overall urinary incontinence (stress and urge incontinence) [6 and 12 months3, 6 and 12 months post operative]
Subject will complete MESA questionnaire to assess improvement in urge incontinence and stress incontinence
- Sexual function [3, 6 and 12 months post operative]
Subject will complete PISQ-12 questionnaire to assess changes in sexual function.
- Improvement in patient quality of life as it relates to urinary symptoms [3, 6 and 12 months post operative]
Subject will complete IIQ-7 questionnaire to assess changes is quality of life related to urinary symptoms.
- Subject satisfaction with overall improvement from sling procedure [3, 6 and 12 months post operative]
Subject will completed satisfaction questionnaire to determine patients overall satisfaction with the procedure and results
- Post operative pain [pre-procedure to 7 days after procedure]
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.
- Post operative complications [post procedure to 12 months]
At post operative visits patients will be asked and assessed for post operative complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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SUI with hypermobility of the urethrovesical (UV) junction
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American Society of Anesthesiologists (ASA) classes I or II
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Ages ranging 21-89 years
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Have the ability to stand for CST during the procedure
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Have failed behavioral therapy
Exclusion Criteria:
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Patient has not completed childbearing
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ASA classes III or IV
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Need for concomitant surgery
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Poor compliance for office-based approach
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Michigan Institution of Women's Health PC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ODISST