Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Restricted postoperative activity; Other: liberal postoperative activity

• Registration Number: NCT02138487
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Study Start: 2014-08
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restricted postoperative activity	Restricted postoperative activity	Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively
Liberal postoperative activity	liberal postoperative activity	Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (3)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Virginia Tech Carilion School of Medicine; 🇺🇸 Roanoke, Virginia, United States

Northwestern University, Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States