Urinary Retention PostoperativeCARES2NCT06344884
Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
A study testing Early catheter removal in people with Urinary Retention Postoperative and Postoperative Urinary Tract Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention Postoperative, Postoperative Urinary Tract Infection, Catheter Site Pain
- What is being tested?
- Early catheter removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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. -
- Conditions
- Urinary Retention Postoperative, Postoperative Urinary Tract Infection, Catheter Site Pain
- Being tested
- Early catheter removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early catheter removalProcedure or surgery
Catheter removal the day after surgery as opposed to standard of care (3 to 4 days after surgery)
| Study group | Role | What they receive |
|---|---|---|
| Early Catheter Removal | Experimental | Participants in this arm will be asked to remove their catheters POD1. Receives: Procedure: Early catheter removal |
| Standard Catheter Removal | No intervention | Participants in this arm will be asked to remove their catheters POD3-4. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Postoperative day 1 through postoperative week 8
Secondary outcomes (8)
Number of patient contacts for voiding dysfunction by Type
Nursing calls, patient messages, and/or office visits will be summarized.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start24 Jun 2024
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Tholemeier, MD, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344884
- Sponsor's protocol ID
- 23-2619
- Acronym
- CARES2
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT06344884
- Acronym / sponsor ID
- CARES2 / 23-2619
- Conditions
- Urinary Retention Postoperative, Postoperative Urinary Tract Infection, Catheter Site Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Early Catheter Removal | Experimental | Procedure: Early catheter removalParticipants in this arm will be asked to remove their catheters POD1. |
| Standard Catheter Removal | No intervention | –Participants in this arm will be asked to remove their catheters POD3-4. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early catheter removalCatheter removal the day after surgery as opposed to standard of care (3 to 4 days after surgery) | Procedure or surgery | Early Catheter Removal |
Primary outcome
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.
8 secondary outcomes
Number of patient contacts for voiding dysfunction by Type
Time frame: From Postoperative day 1 through postoperative week 8
Total patient contacts for voiding dysfunction Combined
Time frame: From Postoperative day 1 through postoperative week 8
Number of patients treated for postoperative UTI.
Time frame: From Postoperative day 1 through postoperative week 8
Number of patients with ongoing urinary retention
Time frame: From Postoperative day 1 through postoperative week 8
Patient Satisfaction Survey Score-Pain
Time frame: Postoperative week 2
Patient Satisfaction Survey Score-Ease of Use
Time frame: Postoperative week 2
Patient Satisfaction Survey Score-Satisfaction
Time frame: Postoperative week 2
Patient Satisfaction Survey Score-Likelihood to Use Again
Time frame: Postoperative week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Tholemeier, MD principal investigator
University of North Carollina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early catheter removal in people with Urinary Retention Postoperative and Postoperative Urinary Tract Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with ongoing urinary retention (noninferiority) (time frame: From Postoperative day 1 through postoperative week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.