Patient Removal of Catheters After Urogynecologic Surgery (CARES)

Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Urinary Retention Postoperative
• Intervention / Treatment: Procedure: Catheter 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Hillsborough, North Carolina, United States, 27287
      • UNC Hillsborough Hospital
    • Raleigh, North Carolina, United States, 27607
      • UNC Rex Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home removal of catheter after surgery; 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.	Procedure: Catheter removal; Catheter management strategy after surgery
Active Comparator: Office removal of catheter after surgery; 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.	Procedure: Catheter removal; Catheter management strategy after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2-5 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 week postoperative period

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Ijeoma Agu, MD, UNC Chapel Hill; Principal Investigator: Jennifer M Wu, MD, MPH, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention
• Other Study ID Numbers: 20-3376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No