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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Patient Satisfaction
• Urinary Retention
• Urinary Retention Postoperative

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