205 Participants Needed

Post-Operative Activity Restriction Duration for Stress Urinary Incontinence

PA
OH
Overseen ByOz Harmanli, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

OH

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?
2Treatment groups
Experimental Treatment
Group I: 6-week post-operative activity restrictionExperimental Treatment1 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 restrictionExperimental Treatment1 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.

Find a Clinic Near You

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 profile image

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 profile image

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

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