Status:
ACTIVE_NOT_RECRUITING
Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
Lead Sponsor:
Yale University
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Urinary Stress Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This is a blinded, randomized controlled trial. Patients undergoing midurethral sling placement for stress urinary incontinence will be asked to participate in the study. If eligible and willing to pa...
Eligibility Criteria
Inclusion
- At least 18 years of age,
- Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence
Exclusion
- • Patients who are unable to read, understand, or complete study documents in English or Spanish
- Patient undergoing concomitant surgery for pelvic organ prolapse other than midurethral sling
- Patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04817839
Start Date
July 1 2021
End Date
January 1 2025
Last Update
October 28 2024
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06512