Patient Removal of Catheters After Urogynecologic Surgery

Not Applicable

Completed

• Conditions: Urinary Retention Postoperative; Patient Satisfaction
• Interventions: Procedure: Catheter removal

• Registration Number: NCT04783012
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Primary Completion: 2022-07-30
• Study Completion: 2022-09-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
• 18+ years old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home removal of catheter after surgery	Catheter removal	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.
Office removal of catheter after surgery	Catheter removal	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

UNC Hillsborough Hospital; 🇺🇸 Hillsborough, North Carolina, United States

UNC Rex Hospital; 🇺🇸 Raleigh, North Carolina, United States