CARES: Patient Removal of Catheters After Urogynecologic Surgery

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT04783012
Collaborator
(none)
240
2
2
32.5
120
3.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Catheter removal
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
Actual Study Start Date :
Feb 15, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Risk of Urinary Retention in the Early Postoperative Period [2-5 days postoperatively]

    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

  1. Number of nursing calls and office visits for urinary issues in the six week postoperative period [6 week postoperative period]

    Number of nursing calls and office visits for voiding issues (including catheter issues, voiding dysfunction and urinary retention) will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UNC Hillsborough Hospital Hillsborough North Carolina United States 27287
2 UNC Rex Hospital Raleigh North Carolina United States 27607

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Amy L Askew, MD, MPH, UNC Chapel Hill
  • Principal Investigator: Jennifer M Wu, MD, MPH, UNC Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT04783012
Other Study ID Numbers:
  • 20-3376
First Posted:
Mar 4, 2021
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022