Post-Operative Activity Restriction Duration for Stress Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.
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