Restricted Convalescence: Outcomes Following Urogynecologic Procedures



Status:Active, not recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:1/20/2019
Start Date:August 2014
End Date:December 2019

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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.

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.

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
We found this trial at
3
sites
Roanoke, Virginia 24016
Principal Investigator: Jonathan L Gleason, MD
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Sarah Collins, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Kimberly S Kenton, MD, MS
Phone: 312-472-3874
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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