ReCOUP: Restricted Convalescence: Outcomes Following Urogynecologic Procedures
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Satisfaction [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
- Anatomic Outcomes [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 [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 [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 [12 weeks and 1 year]
Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ambulatory women undergoing surgical management of pelvic organ prolapse
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Prolapse > to Stage II on POP-Q
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Age >18 yrs
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Completed childbearing
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All subjects must have given signed, informed consent prior to registration on study
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All subjects must be able to read and complete study documents
Exclusion Criteria:
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Wheelchair-bound women
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Women with neurologic disease (Multiple Sclerosis, Parkinson's Disease)
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Abdominal approach with laparotomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University, Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 2 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 3 | Virginia Tech Carilion School of Medicine | Roanoke | Virginia | United States | 24016 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Kimberly Kenton, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00084995