Post-Operative Activity Restriction Duration for Stress Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the optimal duration for limiting activities after surgery for stress urinary incontinence, a condition where urine leaks during activities like coughing or exercising. The study compares two groups: one with a 3-week post-operative activity restriction and another with a 6-week restriction. The goal is to determine which restriction period leads to better recovery and satisfaction. Participants should be able to walk around and must be scheduled only for midurethral sling surgery to treat stress urinary incontinence. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance post-surgical recovery guidelines.
Do I need to stop taking my current medications for this 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 these post-operative activity restrictions are safe?
Research has shown that both 3-week and 6-week activity restrictions after midurethral sling surgery are generally well-tolerated. One study found that patients who resumed normal activities after 3 weeks reported greater satisfaction than those who waited 6 weeks. This suggests a shorter restriction period might be more comfortable and satisfying. Another study found similar rates of stress incontinence (urine leakage during physical activity) in both groups, indicating no major safety concerns with either duration. Overall, current evidence suggests neither approach poses significant safety risks to participants.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores whether shorter post-operative activity restrictions can be just as effective as longer ones for stress urinary incontinence. Traditionally, patients are advised to limit activities for several weeks to ensure proper healing. However, this study compares a 3-week restriction to the standard 6-week period, potentially reducing downtime for patients. If successful, this could mean a quicker return to normal activities without compromising recovery, offering a more flexible and patient-friendly approach.
What evidence suggests that this trial's post-operative activity restrictions could be effective for stress urinary incontinence?
This trial will compare two durations of post-operative activity restriction for stress urinary incontinence: a 3-week restriction and a 6-week restriction. Studies have shown that the duration of activity limitation after a midurethral sling procedure might not significantly affect outcomes. One study found no major difference in bladder control between women who adhered to traditional activity restrictions and those with fewer restrictions. Another study noted that the return of stress incontinence was similar for both groups. These findings suggest that whether activities are limited for 3 or 6 weeks, it may not greatly impact recovery or satisfaction. However, research continues to determine the best recovery plan.23678
Who Is on the Research Team?
Oz Harmanli, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for ambulatory patients at least 18 years old who are scheduled for midurethral sling surgery to treat stress urinary incontinence. Participants must be able to understand and complete study documents in English or Spanish, and commit to not lifting heavy objects (over 20 lbs) for 6 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo midurethral sling placement and follow either a 3-week or 6-week post-operative activity restriction
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 6 weeks, 6 months, and 1 year
What Are the Treatments Tested in This Trial?
Interventions
- 3-week post-operative activity restriction
- 6-week post-operative activity restriction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology