Status:
COMPLETED
Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse
Lead Sponsor:
Duke University
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The objective of the EVeRLAST study is to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic ...
Detailed Description
Specific aim 1: Determine if liberal (ad lib) resumption of postoperative activity levels is non-inferior to standard restrictions with regards to short-term anatomic and symptomatic outcome, as measu...
Eligibility Criteria
Inclusion
- Stage II-IV pelvic organ prolapse
- Bothersome bulge symptoms
- At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form
- English-speaking
- Undergoing treatment of prolapse
- Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data)
- Able and willing to follow up at 3 months for in-office exam
Exclusion
- Enrollment in another research study of pelvic organ prolapse
- Concomitant non-urogynecologic surgery
- Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT04329715
Start Date
July 1 2020
End Date
February 15 2022
Last Update
March 8 2022
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710