Early Patient Removal of Urinary Catheters After Urogynecologic Surgery

NCT06344884 | Completed

• 1 other identifier: 23-2619
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4.

Conditions

Postoperative Urinary Tract Infection; Catheter Site Pain; Urinary Retention Postoperative

Outcome Measures

Primary Outcomes (1)

• Number of patients with ongoing urinary retention (noninferiority)

  Defined as need for catheter replacement or clean intermittent self catheterization (CISC) after catheter removal on POD1 vs POD3-4. A 95% confidence interval of the difference in proportions between the two groups will be used to assess the tenability of a non-inferiority proposition.

  From Postoperative day 1 through postoperative week 8

Secondary Outcomes (8)

• Number of patient contacts for voiding dysfunction by Type

  From Postoperative day 1 through postoperative week 8

• Total patient contacts for voiding dysfunction Combined

  From Postoperative day 1 through postoperative week 8

• Number of patients treated for postoperative UTI.

  From Postoperative day 1 through postoperative week 8

• Number of patients with ongoing urinary retention

  From Postoperative day 1 through postoperative week 8

• Patient Satisfaction Survey Score-Pain

  Postoperative week 2

Study Arms (2)

Early Catheter Removal

EXPERIMENTAL

Participants in this arm will be asked to remove their catheters POD1.

Procedure: Early catheter removal

Standard Catheter Removal

NO INTERVENTION

Participants in this arm will be asked to remove their catheters POD3-4.

Interventions

Early catheter removal PROCEDURE

Catheter removal the day after surgery as opposed to standard of care (3 to 4 days after surgery)

Early Catheter Removal

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge.

You may not qualify if:

• Non-English speaking (due to limited resources to consent non-English speaking patients)
• Pregnant
• Postvoid residual (PVR) \>150 mL or dependent upon catheterization to void pre-operatively
• Intra-operative complication requiring prolonged catheterization

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Health Rex

Raleigh, North Carolina, 27607, United States

Location

Study Officials

• Lauren Tholemeier, MD

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: June 24, 2024
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 to 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)