Patient Removal of Catheters After Urogynecologic Surgery

NCT04783012 | Completed DMC

• 1 other identifier: 20-3376
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Retention Postoperative; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of nursing calls and office visits for urinary issues in the six week postoperative period

  6 week postoperative period

Study Arms (2)

Home removal of catheter after surgery

EXPERIMENTAL

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

Office removal of catheter after surgery

ACTIVE COMPARATOR

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

Interventions

Catheter removal PROCEDURE

Catheter management strategy after surgery

Home removal of catheter after surgery; Office removal of catheter after surgery

Eligibility Criteria

• Age: 18 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
• + years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

UNC Hillsborough Hospital

Hillsborough, North Carolina, 27287, United States

Location

UNC Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Related Publications (1)

• Askew AL, Margulies SL, Agu I, LeCroy KM, Geller E, Wu JM. Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Feb 1;143(2):165-172. doi: 10.1097/AOG.0000000000005454. Epub 2023 Nov 14.

  PMID: 37963385 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ijeoma Agu, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jennifer M Wu, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 4, 2021
• Study Start: February 15, 2021
• Primary Completion: July 30, 2022
• Study Completion: September 9, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 to 36 months following publication
• Access Criteria: Obtains approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (2)