Urinary Retention PostoperativeCARESNCT04783012
Patient Removal of Catheters After Urogynecologic Surgery
A study testing Catheter removal in people with Urinary Retention Postoperative and Patient Satisfaction, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention Postoperative, Patient Satisfaction
- What is being tested?
- Catheter removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2021to 9 Sep 2022
- 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 years and older
- 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
- 18+ years old
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC Hillsborough Hospital
Hillsborough, North Carolina, 27287
UNC Rex Hospital
Raleigh, North Carolina, 27607
About this study
Official title: Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
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.
Read the 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.
- Being tested
- Catheter removal
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter removalProcedure or surgery
Catheter management strategy after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-5 days postoperatively
Secondary outcomes (1)
Number of nursing calls and office visits for urinary issues in the six week postoperative period
Number of nursing calls and office visits for voiding issues (including catheter issues, voiding dysfunction and urinary retention) will be measured.
Measured: 6 week postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Feb 2021
- Primary completion30 Jul 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ijeoma Agu, MD, Principal investigator, UNC Chapel HillJennifer M Wu, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783012
- Sponsor's protocol ID
- 20-3376
- Acronym
- CARES
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Publications
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.
PubMed 37963385
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT04783012
- Acronym / sponsor ID
- CARES / 20-3376
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 4 Mar 2021 (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. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home removal of catheter after surgery | Experimental | Procedure: Catheter removalPatients 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. |
| Office removal of catheter after surgery | Active comparator | Procedure: Catheter removalPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge
- 18+ years old
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Catheter removalCatheter management strategy after surgery | Procedure or surgery | Home removal of catheter after surgery, Office removal of catheter after surgery |
Primary outcome
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.
1 secondary outcome
Number of nursing calls and office visits for urinary issues in the six week postoperative period
Time frame: 6 week postoperative period
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 18 Jul 2023.
- Derived from this study: PubMed 37963385Askew 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.
- 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.
Related trials for Urinary Retention Postoperative
Not yet recruitingPhase 4
Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial)
Benign Prostatic Hyperplasia
Recruiting
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Urinary Catheters, Rectal Cancer
RecruitingPhase 3
Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection
Urinary Retention, Colorectal Surgery
RecruitingEarly Phase 1
Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
Urinary Retention
Recruiting
Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer
Postoperative Urinary Retention (POUR)
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.
Ijeoma Agu, MD principal investigator
UNC Chapel Hill
Jennifer M Wu, MD, MPH principal investigator
UNC Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter removal in people with Urinary Retention Postoperative and Patient Satisfaction, run by University of North Carolina, Chapel Hill at 2 sites 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 2 inclusion and 6 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 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Risk of Urinary Retention in the Early Postoperative Period (time frame: 2-5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783012, which also lists 1 linked publication.
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 18 Jul 2023.