Post-Operative Activity Restriction Duration for Stress Urinary Incontinence

Overseen By Oz Harmanli, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Non-English speakers, Pelvic prolapse surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3-6 weeks

205 Participants Needed

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

I can walk and am scheduled for a specific surgery to treat stress urinary incontinence.

Exclusion Criteria

I cannot read or understand English or Spanish well enough to complete study documents.

I can avoid heavy lifting (20 lbs) for 6 weeks.

I am having surgery for pelvic organ prolapse not including a midurethral sling.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo midurethral sling placement and follow either a 3-week or 6-week post-operative activity restriction

3-6 weeks

1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 6 weeks, 6 months, and 1 year

1 year

Multiple visits (in-person and virtual) for assessments

What Are the Treatments Tested in This Trial?

Interventions

• 3-week post-operative activity restriction
• 6-week post-operative activity restriction

Trial Overview The study compares two different durations of activity restrictions after midurethral sling surgery: one group will have a 3-week restriction, while the other will have a 6-week restriction. The focus is on postoperative outcomes and patient satisfaction.

How Is the Trial Designed?

Group I: 6-week post-operative activity restriction Experimental Treatment 1 Intervention

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.

Group II: 3-week post-operative activity restriction Experimental Treatment 1 Intervention

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

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