Restricted Convalescence: Outcomes Following Urogynecologic Procedures (ReCOUP)

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: Restricted postoperative activity; Other: liberal postoperative activity

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Feinberg School of Medicine
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Virginia Tech Carilion School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction	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."	12 weeks following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic Outcomes	Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery.	12 weeks and 1 year following surgery
Quality of Life	Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse.	12 weeks and 1 year following surgery
Pain	Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.	12 weeks and 1 year following surgery
Activity level	Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.	12 weeks and 1 year

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Kimberly Kenton, MD, Northwestern University

Publications and helpful links

General Publications

• Mueller MG, Collins SA, Lewicky-Gaupp C, Tavathia M, Kenton K. Restricted Convalescence Following Urogynecologic Procedures: 1-Year Outcomes From a Randomized Controlled Study. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e336-e341. doi: 10.1097/SPV.0000000000000922.
• Bochenska K, Hall E, Griffith JW, Kenton K, Alverdy A, Lewicky-Gaupp C, Mueller M. The Promise of PROMIS in Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Nov-Dec;25(6):426-429. doi: 10.1097/SPV.0000000000000685.
• Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: patient satisfaction; pelvic organ prolapse; reconstructive pelvic surgery; postoperative restrictions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Convalescence
• Other Study ID Numbers: STU00084995