Single-Incision Sling for Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for stress urinary incontinence (SUI), where physical activities like coughing or exercising cause involuntary urine leakage. The study tests a procedure called the Single-Incision Sling, a surgical treatment performed in a doctor's office, to assess its practicality and effectiveness. The goal is to evaluate its success, identify any complications, and gather feedback from patients and doctors. Participants should have SUI with a mobile connection between the bladder and urethra, have not improved with behavior changes, and be able to stand during the procedure. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to new treatment options for SUI.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this technique is safe for urinary incontinence?
Research has shown that single-incision slings for urinary incontinence are generally safe. Studies involving thousands of women have tested these slings. One large study found that only up to 19% of patients required another surgery within five years, indicating that these slings work well for most. Another study found that serious issues, such as organ injury, were rare. Overall, the slings are well-tolerated, and most patients experience good results.12345
Why are researchers excited about this trial?
The Single-Incision Sling is unique because it offers a less invasive option for treating urinary incontinence compared to traditional multi-incision slings. Most standard treatments require multiple incisions, which can lead to longer recovery times and increased risk of complications. This single-incision approach simplifies the procedure, potentially reducing recovery time and minimizing discomfort. Researchers are excited about this treatment because it could provide a quicker, more comfortable recovery experience for patients while maintaining the effectiveness of traditional methods.
What evidence suggests that the Single-Incision Sling is effective for urinary incontinence?
Research has shown that single-incision slings, the treatment under study in this trial, can effectively treat stress urinary incontinence. One study found that 85.7% of patients improved based on a 24-hour pad test, which measures leakage. Another study reported that only 10% of patients experienced sling failure, mostly within the first two years after the procedure. The need for additional surgery with these slings remains relatively low, ranging from 0% to 19% over five years. Overall, these slings offer a promising option for managing urinary incontinence.12346
Who Is on the Research Team?
Salil Khandwala, MD
Principal Investigator
Advanced Urogynecology of Michigan, P.C.
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Solyx SIMUS procedure using the Dynamic Interactive Standing Sling Technique (DISST) in an office setting
Follow-up
Participants are monitored for post-operative complications, quality of life, and satisfaction with the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Single-Incision Sling
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michigan Institution of Women's Health PC
Lead Sponsor