Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Restricted Convalescence: Outcomes Following Urogynecologic Procedures (ReCOUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138487
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Kimberly Kenton, Northwestern University

Brief Summary:
The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: liberal postoperative activity Other: Restricted postoperative activity Not Applicable

Detailed Description:
Pelvic floor disorders (PFD) dramatically affect millions of women's quality of life (QOL), and 30% of American women will undergo reconstructive surgery for urinary incontinence or pelvic organ prolapse to improve bothersome symptoms and quality of life. Surgical goals of women with PFD is often to resume their normal activities, which they have limited secondary to bothersome symptoms. Yet, traditionally surgeons placed strict postoperative restrictions on patient's activity levels for 3 months; sometimes even recommending life long lifting and activity restrictions. Activity restrictions are imposed on the premise that exercise can "weaken" surgical healing; however, emerging data from other fields suggests that increased activity may actually promote the healing process. We aim to determine whether satisfaction, recovery, and anatomic outcomes after surgery are related to type of postoperative activity recommendations (liberal versus restricted). Women having surgery for PFD will be randomized to receive either liberal or restricted postoperative activity recommendations and satisfaction, symptoms, QOL and anatomic outcomes will be measured after surgery. We hypothesize that women with liberal activity recommendations will recover more quickly and report higher satisfaction and QOL, have fewer symptoms, and have similar anatomic outcomes to women with restricted activity restrictions. These data will change paradigms of women's health and recovery after surgery.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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."


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory women undergoing surgical management of pelvic organ prolapse
  • Prolapse > to Stage II on POP-Q
  • Age >18 yrs
  • Completed childbearing
  • All subjects must have given signed, informed consent prior to registration on study
  • All subjects must be able to read and complete study documents

Exclusion Criteria:

  • Wheelchair-bound women
  • Women with neurologic disease (Multiple Sclerosis, Parkinson's Disease)
  • Abdominal approach with laparotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138487


Locations
Layout table for location information
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
Sponsors and Collaborators
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: Kimberly Kenton, MD Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kimberly Kenton, Professor of Obstetrics and Gynecology, Professor of Urology, Division Chief Female Pelvic Medicine and Reconstructive Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT02138487    
Other Study ID Numbers: STU00084995
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by Kimberly Kenton, Northwestern University:
pelvic organ prolapse
reconstructive pelvic surgery
postoperative restrictions
patient satisfaction
Additional relevant MeSH terms:
Layout table for MeSH terms
Prolapse
Pelvic Organ Prolapse
Convalescence
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes