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Sling

Single-Incision Sling for Stress 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

Study 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.Check my eligibility

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.See study design

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.

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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6,12, 24 and 60 months post operative

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-Incision SlingExperimental Treatment1 Intervention

Intervention with in office solyx suburethral sling DISST

0 / 4Eligibility criteria met

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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to enroll as a participant in this medical study?

"In order to qualify for participation in this clinical trial, individuals must exhibit symptoms of stress incontinence and fall within the age range of 18 to 89. Roughly 20 eligible candidates are being sought for recruitment into the study."

Answered by AI

Are individuals currently able to apply and participate in this ongoing clinical trial?

"Apologies for the confusion. According to clinicaltrials.gov, this specific trial is currently not recruiting patients. It was initially posted on May 31st, 2019 and last updated on January 18th, 2024. However, there are currently numerous other trials actively seeking participants with a total of 149 ongoing studies available for potential enrollment."

Answered by AI

Is the age criterion for participating in this medical study limited to individuals below 70 years old?

"To be eligible for participation in this clinical trial, applicants must fall within the age range of 18 to 89. There are also separate trials available specifically designed for patients under the age of 18 (16 trials) and those over the age of 65 (133 trials)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Salil Khandwala 2019. "Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03842410.

All > Urinary Incontinence