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NCT04783012 Clinical Trial

Patient Removal of Catheters After Urogynecologic Surgery

Patient Satisfaction Clinical Trial

— CARES  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04783012
Other study ID # 20-3376
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2021
Est. completion date September 9, 2022

Study information
Verified date March 2023
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date September 9, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Catheter removal
Catheter management strategy after surgery

Locations
Country Name City State
United States UNC Hillsborough Hospital Hillsborough North Carolina
United States UNC Rex Hospital Raleigh North Carolina

Sponsors (1)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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