Patient Removal of Catheters After Urogynecologic Surgery (CARES)
Primary Purpose
Urinary Retention Postoperative, Patient Satisfaction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Catheter removal
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention Postoperative
Eligibility Criteria
Inclusion Criteria:
- All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
- 18+ years old
Exclusion Criteria:
- Non-English speaking
- Pregnant
- Elevated PVR (>150 mL) or dependent upon catheterization to void pre-operatively
- Urethral bulking injection surgery
- Intra-operative complication requiring prolonged catheterization
- Unable or unwilling to remove catheter at home
Sites / Locations
- UNC Hillsborough Hospital
- UNC Rex Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home removal of catheter after surgery
Office removal of catheter after surgery
Arm Description
Patients randomized to home removal will be assigned to remove their catheters on postoperative day (POD) 2 (or if Th/F surgery, POD 4 or POD 3, respectively). They will be handed an instructional packed with visual, written and video instructions for catheter removal.
Patients randomized to office removal will be assigned to return to the office on POD 2 (or if Th/F surgery, POD 4 or POD 3, respectively) for standard nurse visit with backfill, catheter removal and voiding trial in the office.
Outcomes
Primary Outcome Measures
Risk of Urinary Retention in the Early Postoperative Period
The percentage of patients who have urinary retention in the early postoperative period (failed voiding trial after discharge POD 2-5) will be measured.
Secondary Outcome Measures
Number of nursing calls and office visits for urinary issues in the six week postoperative period
Number of nursing calls and office visits for voiding issues (including catheter issues, voiding dysfunction and urinary retention) will be measured.
Full Information
NCT ID
NCT04783012
First Posted
February 19, 2021
Last Updated
July 17, 2023
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04783012
Brief Title
Patient Removal of Catheters After Urogynecologic Surgery
Acronym
CARES
Official Title
Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Management of postoperative urinary retention often requires the use of indwelling catheters. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.
Detailed Description
Voiding trials are a routine part of Urogynecologic surgery. Management of postoperative urinary retention often requires the use of indwelling catheters. However, patients often view the need for catheters as the worst part of their surgical experience, and follow-up voiding trials in the office utilize excess healthcare resources. Many Urology practices allow patient removal of catheters after procedures, though this has not been formally studied. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative, Patient Satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home removal of catheter after surgery
Arm Type
Experimental
Arm Description
Patients randomized to home removal will be assigned to remove their catheters on postoperative day (POD) 2 (or if Th/F surgery, POD 4 or POD 3, respectively). They will be handed an instructional packed with visual, written and video instructions for catheter removal.
Arm Title
Office removal of catheter after surgery
Arm Type
Active Comparator
Arm Description
Patients randomized to office removal will be assigned to return to the office on POD 2 (or if Th/F surgery, POD 4 or POD 3, respectively) for standard nurse visit with backfill, catheter removal and voiding trial in the office.
Intervention Type
Procedure
Intervention Name(s)
Catheter removal
Intervention Description
Catheter management strategy after surgery
Primary Outcome Measure Information:
Title
Risk of Urinary Retention in the Early Postoperative Period
Description
The percentage of patients who have urinary retention in the early postoperative period (failed voiding trial after discharge POD 2-5) will be measured.
Time Frame
2-5 days postoperatively
Secondary Outcome Measure Information:
Title
Number of nursing calls and office visits for urinary issues in the six week postoperative period
Description
Number of nursing calls and office visits for voiding issues (including catheter issues, voiding dysfunction and urinary retention) will be measured.
Time Frame
6 week postoperative period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
18+ years old
Exclusion Criteria:
Non-English speaking
Pregnant
Elevated PVR (>150 mL) or dependent upon catheterization to void pre-operatively
Urethral bulking injection surgery
Intra-operative complication requiring prolonged catheterization
Unable or unwilling to remove catheter at home
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ijeoma Agu, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer M Wu, MD, MPH
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Hillsborough Hospital
City
Hillsborough
State/Province
North Carolina
ZIP/Postal Code
27287
Country
United States
Facility Name
UNC Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
Beginning 9 to 36 months following publication
IPD Sharing Access Criteria
Obtains approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Learn more about this trial
Patient Removal of Catheters After Urogynecologic Surgery
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