NCT03842410

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Michigan Institution of Women's Health PC · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Single-Incision Sling	Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.

Timeline

• Start date: 2019-05-31
• Primary completion: 2020-03-15
• Completion: 2025-03-01
• First posted: 2019-02-15
• Last updated: 2024-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study