Restricted Convalescence: Outcomes Following Urogynecologic Procedures (ReCOUP)
|ClinicalTrials.gov Identifier: NCT02138487|
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse||Other: liberal postoperative activity Other: Restricted postoperative activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Restricted Convalescence: Outcomes Following Urogynecologic Procedures|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
Active Comparator: Restricted postoperative activity
Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively
Other: Restricted postoperative activity
Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.
Experimental: Liberal postoperative activity
Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.
Other: liberal postoperative activity
Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.
- Satisfaction [ Time Frame: 12 weeks following surgery ]Satisfaction will be assessed following reconstructive pelvic surgery for prolapse using a question which assesses a patient's global impression. Specifically, patients will be asked the question "how satisfied are you with your prolapse surgery?" at 12 wks to assess overall satisfaction. Possible responses include "completely satisfied," "mostly satisfied," "neutral," "mostly dissatisfied," and "completely dissatisfied."
- Anatomic Outcomes [ Time Frame: 12 weeks and 1 year following surgery ]Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery.
- Quality of Life [ Time Frame: 12 weeks and 1 year following surgery ]Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse.
- Pain [ Time Frame: 12 weeks and 1 year following surgery ]Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.
- Activity level [ Time Frame: 12 weeks and 1 year ]Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138487
|United States, Illinois|
|Northwestern University, Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Virginia|
|Virginia Tech Carilion School of Medicine|
|Roanoke, Virginia, United States, 24016|
|Principal Investigator:||Kimberly Kenton, MD||Northwestern University|