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

Enrollment

Locations

Arms

32.5

Anticipated Duration (Months)

120

Patients Per Site

3.7

Patients Per Site Per Month

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
Urinary Retention Postoperative Patient Satisfaction	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

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

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

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:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Retention

Study Results

No Results Posted as of Apr 25, 2022