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Sling

Single-Incision Sling for Urinary Incontinence

N/A
Waitlist Available
Led By Salil Khandwala, M.D.
Research Sponsored by Michigan Institution of Women's Health PC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have the ability to stand for CST during the procedure
American Society of Anesthesiologists (ASA) classes I or II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6,12, 24 and 60 months post operative
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine if it's possible and effective to perform a procedure called SolyxTM SIMUS in a doctor's office using a technique called Dynamic Interactive Standing Sling Technique (DISSTTM

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the site of insertion, infection risk, temporary urinary retention or difficulty urinating, and possible injury to surrounding tissues or organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stand for the CST procedure.
Select...
I am in good or mild systemic disease according to ASA classification.
Select...
I have stress urinary incontinence due to bladder neck movement.
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I am between 21 and 89 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6,12, 24 and 60 months post operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6,12, 24 and 60 months post operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability to achieve DISST SUCCESS
Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)
+1 more
Secondary study objectives
Improvement in overall urinary incontinence (stress and urge incontinence)
Improvement in patient quality of life as it relates to urinary symptoms
Post operative complications
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-Incision SlingExperimental Treatment1 Intervention
Intervention with in office solyx suburethral sling DISST

Find a Location

Who is running the clinical trial?

Michigan Institution of Women's Health PCLead Sponsor
7 Previous Clinical Trials
371 Total Patients Enrolled
Salil Khandwala, M.D.Principal InvestigatorAdvanced Urogynecology of Michigan, P.C.
~3 spots leftby Nov 2025
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