Skip to main content
OpenTrials
Completed

NCT Number: NCT06344884

Early Patient Removal of Urinary Catheters After Urogynecologic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Health Rex

Raleigh, North Carolina, 27607, United States

About this study

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. -

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Intra-operative complication requiring prolonged catheterization

Treatment and study plan

Early catheter removal

Procedure

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

Primary outcomes

  1. Number of patients with ongoing urinary retention (noninferiority)

    Time frame: From Postoperative day 1 through postoperative week 8

    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.

Secondary outcomes

  1. Number of patient contacts for voiding dysfunction by Type

    Time frame: From Postoperative day 1 through postoperative week 8

    Nursing calls, patient messages, and/or office visits will be summarized.

  2. Total patient contacts for voiding dysfunction Combined

    Time frame: From Postoperative day 1 through postoperative week 8

    The total number of nursing calls, patient messages, and/or office visits combined.

  3. Number of patients treated for postoperative UTI.

    Time frame: From Postoperative day 1 through postoperative week 8

    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.

  4. Number of patients with ongoing urinary retention

    Time frame: From Postoperative day 1 through postoperative week 8

    Defined as need for catheter replacement or clean intermittent self catheterization (CISC) after catheter removal on POD 1 vs 3-4.

  5. Patient Satisfaction Survey Score-Pain

    Time frame: Postoperative week 2

    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.

  6. Patient Satisfaction Survey Score-Ease of Use

    Time frame: Postoperative week 2

    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.

  7. Patient Satisfaction Survey Score-Satisfaction

    Time frame: Postoperative week 2

    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.

  8. Patient Satisfaction Survey Score-Likelihood to Use Again

    Time frame: Postoperative week 2

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Acronym: CARES2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.