Overview

This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatments liberal postoperative activity, restricted postoperative activity
Sponsor Northwestern University
Start date August 2014
End date April 2017
Trial size 108 participants
Trial identifier NCT02138487, STU00084995

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively
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)
Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.
liberal postoperative activity
Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.

Primary Outcomes

Measure
Satisfaction
time frame: 12 weeks following surgery

Secondary Outcomes

Measure
Anatomic Outcomes
time frame: 12 weeks and 1 year following surgery
Quality of Life
time frame: 12 weeks and 1 year following surgery
Pain
time frame: 12 weeks and 1 year following surgery
Activity level
time frame: 12 weeks and 1 year

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Restricted Convalescence: Outcomes Following Urogynecologic Procedures
Principal investigator Kimberly Kenton, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Northwestern University.