Early Patient Removal of Urinary Catheters After Urogynecologic Surgery (CARES2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Retention Postoperative; Postoperative Urinary Tract Infection; Catheter Site Pain
• Intervention / Treatment: Procedure: Early catheter removal

Detailed Description

Randomized, controlled, non-inferiority trial to compare the risk of urinary retention between patient urinary catheter removal on POD1 versus POD3-4 after urogynecologic surgery.

Aim One: Is the risk of urinary retention non-inferior with patient removal of transurethral catheters on POD1 versus POD3-4 after urogynecologic surgery?

Aim Two: Does healthcare resource utilization (nursing calls, patient messages, and office visits) differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Aim Three: Does the patient experience differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Aim Four: Does the incidence of postoperative UTI differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Aim Five: Does the risk of delayed or recurrent postoperative urinary retention differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Screening: Preoperative clinics at UNC Rex Urogynecology will be screened for all women who are undergoing a prolapse or anti-incontinence procedure.

Study Treatment/Intervention

Postoperatively if patients fail their voiding trial in the post-anesthesia care unit (PACU) and are willing to perform home catheter removal after instruction

Patients will be randomized to a catheter management arm: self-catheter removal on POD1 or POD3-4

POD 1 - Patients in the intervention arm will be reminded to remove their catheters

They will be instructed to remove their urinary catheter at 0700 and to call the clinic office by noon if they have not voided

If they are unable to void or have any other concerning symptoms, they will be scheduled for a same day nurse visit

Patients who are unable to void will then be taught clean intermittent self-catheterization, per usual management of postoperative voiding dysfunction

POD 3 (or by POD 4 for Thursday cases) - Patients in the control arm will be reminded to remove their catheters

* Patients undergoing surgery on Thursday will perform catheter removal on Monday. This is what was done in previous studies in order to prevent resource over-utilization on weekends. Patients undergoing surgery on Wednesday (typically only rare add-on cases) will be excluded.

They will be instructed to remove their urinary catheter at 0700 and to call the clinic office by noon if they have not voided

If they are unable to void or have any other concerning symptoms, they will be scheduled for a same day nurse visit

Patients who are unable to void will then be taught clean intermittent self-catheterization, per usual management of postoperative voiding dysfunction

Week 2 Phone Call

Patients will be called by study personnel to check in on any voiding symptoms or issues and complete phone survey regarding the following categories: Pain, Ease of use, Satisfaction, Likelihood to use again.

Week 6 Visit

Patients will have a standard office visit around 6 weeks postoperatively. At this visit, a post-void residual assessment will be performed.

Follow-up through postoperative visit after surgery

Postoperative complications, such as urinary tract infection (UTI) or delayed urinary retention will be monitored from the chart

Patients will be randomized on the day of surgery. Each subject's participation will last from the day of surgery to the day of catheter removal (on POD 1-4). They will also be called two weeks postoperatively for a check-in and survey over the phone. Postoperative complications will be monitored until their postoperative visit at 6-8 weeks after surgery.

The recruitment and data collection period is expected to last one year. The entire study including data collection, analysis and publication will take up to 3 years. -

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Tholemeier, MD; Phone Number: 984-974-0496; Email: lthol@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • UNC Health Rex
      • Contact: Lauren Tholemeier, MD; Phone Number: 984-974-0496; Email: lauren_tholemeier@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Urethral bulking injection surgery
• Intra-operative complication requiring prolonged catheterization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Catheter Removal; Participants in this arm will be asked to remove their catheters POD1.	Procedure: Early catheter removal; Catheter removal the day after surgery as opposed to standard of care (3 to 4 days after surgery)
No Intervention: Standard Catheter Removal; Participants in this arm will be asked to remove their catheters POD3-4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient contacts for voiding dysfunction by Type	Nursing calls, patient messages, and/or office visits will be summarized.	From Postoperative day 1 through postoperative week 8
Total patient contacts for voiding dysfunction Combined	The total number of nursing calls, patient messages, and/or office visits combined.	From Postoperative day 1 through postoperative week 8
Number of patients treated for postoperative UTI.	A case of postoperative UTI will be defined by patient receiving antibiotic treatment for UTI. This typically happens as a result of patient symptoms and/or a positive urine culture.	From Postoperative day 1 through postoperative week 8
Number of patients with ongoing urinary retention	Defined as need for catheter replacement or clean intermittent self catheterization (CISC) after catheter removal on POD 1 vs 3-4.	From Postoperative day 1 through postoperative week 8
Patient Satisfaction Survey Score-Pain	One survey question will be asked regarding Pain on a Likert Scale. The question is scored 0-4 with a higher score representing more pain.	Postoperative week 2
Patient Satisfaction Survey Score-Ease of Use	One survey question will be asked regarding Ease of use on a Likert Scale. The question is scored 0-4 with a higher score meaning more difficulty or a worse outcome.	Postoperative week 2
Patient Satisfaction Survey Score-Satisfaction	One survey question will be asked regarding Satisfaction on a Likert Scale. The question is scored 0-3 with a higher score meaning more satisfied or a better outcome.	Postoperative week 2
Patient Satisfaction Survey Score-Likelihood to Use Again	One survey question will be asked regarding likelihood to use again on a Likert Scale. The question is scored 0-3 with a higher score meaning more likely or a better outcome.	Postoperative week 2

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Lauren Tholemeier, MD, University of North Carollina at Chapel Hill

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections; Urinary Retention
• Other Study ID Numbers: 23-2619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Beginning 9 to 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No