Single-Incision Sling for Urinary Incontinence

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michigan Institution of Women's Health PC

Disqualifiers: Asa iii or iv, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Intraoperative

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Salil Khandwala, MD

Principal Investigator

Advanced Urogynecology of Michigan, P.C.

Eligibility Criteria

This trial is for adults aged 21-89 with stress urinary incontinence who can stand during the procedure and have not improved with behavioral therapy. They should be generally healthy as indicated by ASA classes I or II.

Inclusion Criteria

I can stand for the CST procedure.

I am in good or mild systemic disease according to ASA classification.

You have tried behavioral therapy, but it did not work for you.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Solyx SIMUS procedure using the Dynamic Interactive Standing Sling Technique (DISST) in an office setting

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for post-operative complications, quality of life, and satisfaction with the procedure

60 months

Multiple visits at 3, 6, 12, 24, and 60 months post-operative

Treatment Details

Interventions

• Single-Incision Sling

Trial Overview The study tests if a single-incision sling, known as SolyxTM SIMUS, can be successfully inserted using DISSTTM technique during an office visit to treat urinary incontinence.

Participant Groups

Group I: Single-Incision Sling Experimental Treatment 1 Intervention

Intervention with in office solyx suburethral sling DISST

Who Is Running the Clinical Trial?

Michigan Institution of Women's Health PC

Lead Sponsor

Trials

8

Recruited

390+