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Patient Removal of Catheters After Urogynecologic Surgery (CARES)

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ClinicalTrials.gov Identifier: NCT04783012
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Retention Postoperative Patient Satisfaction Procedure: Catheter removal Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Home removal of catheter after surgery
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
Catheter management strategy after surgery
Active Comparator: Office removal of catheter after surgery
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
Catheter management strategy after surgery


Outcome Measures
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Primary Outcome Measures :
  1. Risk of Urinary Retention in the Early Postoperative Period [ Time Frame: 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 :
  1. Number of nursing calls and office visits for urinary issues in the six week postoperative period [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783012


Contacts
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Contact: Katherine Feliciano (919) 843-8259 Katherine_feliciano@med.unc.edu

Locations
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United States, North Carolina
UNC Hillsborough Hospital Recruiting
Hillsborough, North Carolina, United States, 27287
Contact: Amy Askew, MD    984-974-0498      
UNC Rex Hospital Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Amy Askew, MD    984-974-0498      
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Amy L Askew, MD, MPH UNC Chapel Hill
Principal Investigator: Jennifer M Wu, MD, MPH UNC Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04783012    
Other Study ID Numbers: 20-3376
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases