Restricted Convalescence: Outcomes Following Urogynecologic Procedures (ReCOUP)

Northwestern University

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Other: liberal postoperative activity; Other: Restricted postoperative activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02138487

STU00084995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Restricted postoperative activity

Active Comparator group

Description:

Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively

Treatment:

Other: Restricted postoperative activity

Liberal postoperative activity

Experimental group

Description:

Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.

Treatment:

Other: liberal postoperative activity