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Restricted Convalescence: Outcomes Following Urogynecologic Procedures (ReCOUP)

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
liberal postoperative activity
Restricted postoperative activity
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, reconstructive pelvic surgery, postoperative restrictions, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Northwestern University, Feinberg School of Medicine
  • University of Chicago
  • Virginia Tech Carilion School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Restricted postoperative activity

Liberal postoperative activity

Arm Description

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

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

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Anatomic Outcomes
Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic 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.
Pain
Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.
Activity level
Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.

Full Information

First Posted
May 8, 2014
Last Updated
June 2, 2020
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02138487
Brief Title
Restricted Convalescence: Outcomes Following Urogynecologic Procedures
Acronym
ReCOUP
Official Title
Restricted Convalescence: Outcomes Following Urogynecologic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse, reconstructive pelvic surgery, postoperative restrictions, patient satisfaction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Restricted postoperative activity
Arm Type
Active Comparator
Arm Description
Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively
Arm Title
Liberal postoperative activity
Arm Type
Experimental
Arm Description
Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.
Intervention Type
Other
Intervention Name(s)
liberal postoperative activity
Intervention Description
Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.
Intervention Type
Other
Intervention Name(s)
Restricted postoperative activity
Intervention Description
Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.
Primary Outcome Measure Information:
Title
Satisfaction
Description
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."
Time Frame
12 weeks following surgery
Secondary Outcome Measure Information:
Title
Anatomic Outcomes
Description
Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery.
Time Frame
12 weeks and 1 year following surgery
Title
Quality of Life
Description
Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse.
Time Frame
12 weeks and 1 year following surgery
Title
Pain
Description
Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.
Time Frame
12 weeks and 1 year following surgery
Title
Activity level
Description
Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.
Time Frame
12 weeks and 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Kenton, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Virginia Tech Carilion School of Medicine
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32947549
Citation
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.
Results Reference
derived
PubMed Identifier
30570502
Citation
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.
Results Reference
derived
PubMed Identifier
28277355
Citation
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.
Results Reference
derived

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Restricted Convalescence: Outcomes Following Urogynecologic Procedures

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