Urinary Retention PostoperativeAHEADCARENCT05353400
At Home Early vs. Delayed Catheter Removal Following Failed Postoperative Voiding Trial: a Randomized Trial
A study testing Early urinary catheter removal and Urinary catheter removal on POD 3 in people with Urinary Retention Postoperative, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study aims to investigate whether patients who self-remove their indwelling transurethral catheters on POD 1 have similar rates of postoperative catheter reinsertion for urinary retention (within the first 7 days after surgery) compared with those who undergo catheter self-removal on POD 3. 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
- What is being tested?
- Early urinary catheter removal and Urinary catheter removal on POD 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 6 Apr 2023
- 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
- English speaking Age 18+ Undergoing pelvic reconstructive surgery with ERAS protocol Incomplete bladder emptying after same day VT in PACU (as defined by an ultrasound or straight catheter post void residual of greater than 50% the total instilled volume within 10 minutes following a void postoperatively) Able to complete a telephone appointment on either postoperative day 1 or 3
Who cannot join
- Active urinary tract infection, defined by CDC criteria Patients undergoing pelvic reconstructive surgery where ERAS protocol is not utilized (examples: isolated Labiaplasty, chemodenervation with onabotulinum toxin A, urethral bulking, mid-urethral sling, sacral neuromodulation) Contraindication to ERAS protocol and/or its medications Elevated pre-op PVR greater than 200mL (on urodynamic testing or uroflow or straight catheter sample, that remains elevated after prolapse is reduced) Limited manual dexterity (limiting self-removal of catheter) Intra-op cystotomy or urinary tract injury Planned long term catheterization (e.g., fistula repair, urethral diverticulum) Planned hospital admission or patients who are not discharged from hospital the same day of their surgery Pregnancy Dependent on catheterization to void preoperatively Patients who request clean intermittent catheterization (CIC) after immediate failed VT Neurological conditions that affect voiding function (examples: spinal cord lesions, multiple sclerosis, Parkinson's disease, past stroke history with residual neurologic deficits) Concomitant surgical procedure by another service Conversion to open surgery Patients discharged to nursing home or rehabilitation care facility
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate whether patients who self-remove their indwelling transurethral catheters on POD 1 have similar rates of postoperative catheter reinsertion for urinary retention (within the first 7 days after surgery) compared with those who undergo catheter self-removal on POD 3.
Read the detailed description
Studies estimate the rate of post-operative urinary retention (POUR) after pelvic reconstructive surgery to be between 2.5-43% in all patients1. Consequently, patients undergoing pelvic reconstructive surgery will commonly undergo an assessment of voiding function prior to discharge. Patients who do not successfully complete a voiding trial (VT) are typically discharged from the hospital with a transurethral indwelling catheter. The preferred length of time the catheter remains in place postoperatively, however, varies widely (1 to 7 days) amongst pelvic reconstructive surgeons2-4.
Over the past few years, Enhanced Recovery After Surgery (ERAS) protocols have been adopted for patients undergoing reconstructive vaginal and minimally invasive (laparoscopic or robotic) surgery with increased focus on patient centered outcomes5. The benefits of ERAS in pelvic reconstructive surgery often allow for patients to be discharged home from the hospital the same day of their surgery. Unfortunately, same day discharge is associated with higher rates of postoperative voiding dysfunction and subsequent discharge home with a urinary catheter, with an incidence reported as high as 33.9-36%2,6. This increased rate of postoperative urinary retention has been reflected in our patient population. Prior to the implementation of ERAS in our pelvic reconstructive surgery division at Atrium Health, the rate of discharge home with a urinary catheter after failed VT on postoperative day (POD) 1 was 28%. With the implementation of an ERAS protocol and same day discharge (POD 0), the rate climbed to 43%7. Consequently, a higher percentage of postoperative patients have required a second VT prior to catheter discontinuation. This has necessitated additional clinical visits with a nurse or other provider, further stretching our clinical staff and obligating patients to make an additional trip to the clinic for a repeat postoperative VT.
Recent evidence supports the safety and improved patient experience in patients who self-discontinue a transurethral urinary catheter. In the study by Shatkin-Margolis et al., patients who had undergone pelvic reconstructive surgery were randomized to either self- discontinuation or in office discontinuation overseen by medical personnel one week after surgery8. This study found that self-discontinuation of transurethral catheter was non-inferior to office-based discontinuation following pelvic reconstructive surgery. Additionally, the authors found that self-discontinuation resulted in fewer patient encounters and improved patient experience.
Given this supportive evidence of safe catheter self-discontinuation and our practice's desire to improve patient satisfaction while decreasing clinical burden, we have adopted a practice where the patient self-removes their urinary catheter on the same day that a typical in-office VT would occur (POD 3). During preoperative counseling visits, our patients receive structured handouts with pictorial and descriptive language explaining how to safely self-remove a transurethral catheter (Figure 1). If VT failure should occur, the post anesthesia care unit (PACU) nursing staff review the instructions once again with the patient and the patient's support person(s) prior to discharge. Patients are told to call the office with any symptoms or concerns. Additionally, a nurse from our practice follows up with the patient via telephone on POD 1.
Patient experience following surgery is an important patient centered outcome. Unfortunately, being discharged home with an indwelling transurethral catheter for any amount of time is often perceived by patients as a postoperative complication and is a source of dissatisfaction in patients undergoing pelvic reconstructive surgery9-10. Therefore, decreasing the dissatisfaction surrounding postoperative catheter use improves the patient experience. Several studies have evaluated early postoperative catheter discontinuation after pelvic reconstructive surgery in an effort to limit the length of time that a catheter is in place. In a randomized controlled trial of immediate versus POD1 catheter removal in patients undergoing minimally invasive pelvic reconstructive surgery by Vallabh-Patel et al. the rate of POUR on POD 0 was 31%; however, the rate on POD 1 was 4.5%2. Similar low rates of POUR were noted in a prospective cohort trial performed by Botros et al. which evaluated the effects of a mid-urethral sling at the time of robotic sacrocolpopexy and noted a POD 1 retention rate of 1% in this patient population11. Finally, in a retrospective cohort study incorporating both laparoscopic and vaginal pelvic reconstructive surgery performed by El Hiraki et al., the rate of failed VT within 23 hours of surgery was 11.1% for minimally invasive group and 34% for the vaginal surgery group12. This limited body of evidence suggests that a voiding trial as early as postoperative day 1 seems to yield a voiding trial pass rate of 1-34% in pelvic reconstructive surgery patients.
Our group aims to optimize urinary catheter management for both the patient and the clinical staff in the postoperative period when patients are discharged on the same day of their surgery with a transurethral urinary catheter. We are proposing a non-inferiority trial comparing at home POD 1 catheter removal with at home POD 3 catheter removal (our current standard of practice).
- Conditions
- Urinary Retention Postoperative
- Being tested
- Early urinary catheter removal, Urinary catheter removal on POD 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early urinary catheter removalOther
Also called Catheter Removal on POD 1
Early catheter removal
Urinary catheter removal on POD 3Other
Catheter removal on POD 3
| Study group | Role | What they receive |
|---|---|---|
| (Intervention group): self-removal of transurethral catheter on POD 1 | Experimental | Subjects will self-remove transurethral catheter at home on postop day 1 Receives: Other: Early urinary catheter removal |
| (Standard practice group): self-removal of transurethral catheter on POD 3 | Active comparator | Subjects will self-remove transurethral catheter at home on postop day 3 Receives: Other: Urinary catheter removal on POD 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients requiring re-insertion of a transurethral urinary catheter
Percentage of patients with urinary retention requiring re-insertion of a transurethral urinary catheter or needing to do self catheterization within one week of surgery after catheter self-discontinuation on either POD 1 or POD 3 following pelvic reconstructive surgery utilizing ERAS protocol.
Measured: 7 days
Secondary outcomes (7)
Short Term Catheter Burden Questionnaire
Postoperative patient satisfaction using validated questionnaire-Short Term Catheter Burden Questionnaire (STCBQ)13 recorded on day of catheter removal.
Total scale score from 5 to 30. Higher scores indicate greater embarrassment/bother.
Measured: 7 days
Urinary Force of stream
Urinary Force of stream (FOS) reported in millimeters (mm) on visual analog scale (VAS) for first void after catheter removal 14-15 (Figure 3) recorded on day of catheter removal
Measured: 7 days
Urinary tract infection rate
Urinary tract infection (UTI) rates-first 30 days after surgery defined by the CDC criteria
This will be reported as an absolute number and calculated and reported as a percentage of the total number of patients who had a UTI/ total number of patients in the study.
Measured: 30 days
Number of patient phone calls
Number of patient phone calls to triage nursing or clinic in first 7 days following surgery
Measured: 7 days
Number of visits
Number of visits (Emergency room/clinic/post anesthesia care unit (PACU), other) for catheter reinsertion within 30 days of surgery
Measured: 30 days
Readmission rates
30-day readmission rates
Measured: 30 days
Prolonged catheterization
Need for prolonged catheterization or clean intermittent self catheterization (CIC) for greater than 7 days
This will be reported as an absolute number and calculated and reported as a percentage of the total number of patients who required greater than 7 days of catheterization/ total number of patients in the study.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start29 Jun 2022
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Why it stopped: Low recruitment and attrition of study personnel
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 Wake Forest University Health SciencesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Tarr, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353400
- Sponsor's protocol ID
- IRB00083499
- Other IDs
- V13-30-2022
- Acronym
- AHEADCARE
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At Home Early vs. Delayed Catheter Removal Following Failed Postoperative Voiding Trial: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05353400
- Acronym / sponsor ID
- AHEADCARE / IRB00083499
- Conditions
- Urinary Retention Postoperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment and attrition of study personnel
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 29 Apr 2022 (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.
This study aims to investigate whether patients who self-remove their indwelling transurethral catheters on POD 1 have similar rates of postoperative catheter reinsertion for urinary retention (within the first 7 days after surgery) compared with those who undergo catheter self-removal on POD 3.
Detailed description
Studies estimate the rate of post-operative urinary retention (POUR) after pelvic reconstructive surgery to be between 2.5-43% in all patients1. Consequently, patients undergoing pelvic reconstructive surgery will commonly undergo an assessment of voiding function prior to discharge. Patients who do not successfully complete a voiding trial (VT) are typically discharged from the hospital with a transurethral indwelling catheter. The preferred length of time the catheter remains in place postoperatively, however, varies widely (1 to 7 days) amongst pelvic reconstructive surgeons2-4.
Over the past few years, Enhanced Recovery After Surgery (ERAS) protocols have been adopted for patients undergoing reconstructive vaginal and minimally invasive (laparoscopic or robotic) surgery with increased focus on patient centered outcomes5. The benefits of ERAS in pelvic reconstructive surgery often allow for patients to be discharged home from the hospital the same day of their surgery. Unfortunately, same day discharge is associated with higher rates of postoperative voiding dysfunction and subsequent discharge home with a urinary catheter, with an incidence reported as high as 33.9-36%2,6. This increased rate of postoperative urinary retention has been reflected in our patient population. Prior to the implementation of ERAS in our pelvic reconstructive surgery division at Atrium Health, the rate of discharge home with a urinary catheter after failed VT on postoperative day (POD) 1 was 28%. With the implementation of an ERAS protocol and same day discharge (POD 0), the rate climbed to 43%7. Consequently, a higher percentage of postoperative patients have required a second VT prior to catheter discontinuation. This has necessitated additional clinical visits with a nurse or other provider, further stretching our clinical staff and obligating patients to make an additional trip to the clinic for a repeat postoperative VT.
Recent evidence supports the safety and improved patient experience in patients who self-discontinue a transurethral urinary catheter. In the study by Shatkin-Margolis et al., patients who had undergone pelvic reconstructive surgery were randomized to either self- discontinuation or in office discontinuation overseen by medical personnel one week after surgery8. This study found that self-discontinuation of transurethral catheter was non-inferior to office-based discontinuation following pelvic reconstructive surgery. Additionally, the authors found that self-discontinuation resulted in fewer patient encounters and improved patient experience.
Given this supportive evidence of safe catheter self-discontinuation and our practice's desire to improve patient satisfaction while decreasing clinical burden, we have adopted a practice where the patient self-removes their urinary catheter on the same day that a typical in-office VT would occur (POD 3). During preoperative counseling visits, our patients receive structured handouts with pictorial and descriptive language explaining how to safely self-remove a transurethral catheter (Figure 1). If VT failure should occur, the post anesthesia care unit (PACU) nursing staff review the instructions once again with the patient and the patient's support person(s) prior to discharge. Patients are told to call the office with any symptoms or concerns. Additionally, a nurse from our practice follows up with the patient via telephone on POD 1.
Patient experience following surgery is an important patient centered outcome. Unfortunately, being discharged home with an indwelling transurethral catheter for any amount of time is often perceived by patients as a postoperative complication and is a source of dissatisfaction in patients undergoing pelvic reconstructive surgery9-10. Therefore, decreasing the dissatisfaction surrounding postoperative catheter use improves the patient experience. Several studies have evaluated early postoperative catheter discontinuation after pelvic reconstructive surgery in an effort to limit the length of time that a catheter is in place. In a randomized controlled trial of immediate versus POD1 catheter removal in patients undergoing minimally invasive pelvic reconstructive surgery by Vallabh-Patel et al. the rate of POUR on POD 0 was 31%; however, the rate on POD 1 was 4.5%2. Similar low rates of POUR were noted in a prospective cohort trial performed by Botros et al. which evaluated the effects of a mid-urethral sling at the time of robotic sacrocolpopexy and noted a POD 1 retention rate of 1% in this patient population11. Finally, in a retrospective cohort study incorporating both laparoscopic and vaginal pelvic reconstructive surgery performed by El Hiraki et al., the rate of failed VT within 23 hours of surgery was 11.1% for minimally invasive group and 34% for the vaginal surgery group12. This limited body of evidence suggests that a voiding trial as early as postoperative day 1 seems to yield a voiding trial pass rate of 1-34% in pelvic reconstructive surgery patients.
Our group aims to optimize urinary catheter management for both the patient and the clinical staff in the postoperative period when patients are discharged on the same day of their surgery with a transurethral urinary catheter. We are proposing a non-inferiority trial comparing at home POD 1 catheter removal with at home POD 3 catheter removal (our current standard of practice).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Intervention group): self-removal of transurethral catheter on POD 1 | Experimental | Other: Early urinary catheter removalSubjects will self-remove transurethral catheter at home on postop day 1 |
| (Standard practice group): self-removal of transurethral catheter on POD 3 | Active comparator | Other: Urinary catheter removal on POD 3Subjects will self-remove transurethral catheter at home on postop day 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English speaking Age 18+ Undergoing pelvic reconstructive surgery with ERAS protocol Incomplete bladder emptying after same day VT in PACU (as defined by an ultrasound or straight catheter post void residual of greater than 50% the total instilled volume within 10 minutes following a void postoperatively) Able to complete a telephone appointment on either postoperative day 1 or 3
Key exclusion criteria (1 listed)
- Active urinary tract infection, defined by CDC criteria Patients undergoing pelvic reconstructive surgery where ERAS protocol is not utilized (examples: isolated Labiaplasty, chemodenervation with onabotulinum toxin A, urethral bulking, mid-urethral sling, sacral neuromodulation) Contraindication to ERAS protocol and/or its medications Elevated pre-op PVR greater than 200mL (on urodynamic testing or uroflow or straight catheter sample, that remains elevated after prolapse is reduced) Limited manual dexterity (limiting self-removal of catheter) Intra-op cystotomy or urinary tract injury Planned long term catheterization (e.g., fistula repair, urethral diverticulum) Planned hospital admission or patients who are not discharged from hospital the same day of their surgery Pregnancy Dependent on catheterization to void preoperatively Patients who request clean intermittent catheterization (CIC) after immediate failed VT Neurological conditions that affect voiding function (examples: spinal cord lesions, multiple sclerosis, Parkinson's disease, past stroke history with residual neurologic deficits) Concomitant surgical procedure by another service Conversion to open surgery Patients discharged to nursing home or rehabilitation care facility
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 urinary catheter removalAlso: Catheter Removal on POD 1Early catheter removal | Other | (Intervention group): self-removal of transurethral catheter on POD 1 |
| Urinary catheter removal on POD 3Catheter removal on POD 3 | Other | (Standard practice group): self-removal of transurethral catheter on POD 3 |
Primary outcome
Percentage of patients requiring re-insertion of a transurethral urinary catheter
Time frame: 7 days
Percentage of patients with urinary retention requiring re-insertion of a transurethral urinary catheter or needing to do self catheterization within one week of surgery after catheter self-discontinuation on either POD 1 or POD 3 following pelvic reconstructive surgery utilizing ERAS protocol.
7 secondary outcomes
Short Term Catheter Burden Questionnaire
Time frame: 7 days
Urinary Force of stream
Time frame: 7 days
Urinary tract infection rate
Time frame: 30 days
Number of patient phone calls
Time frame: 7 days
Number of visits
Time frame: 30 days
Readmission rates
Time frame: 30 days
Prolonged catheterization
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Low recruitment and attrition of study personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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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.
Megan Tarr principal investigator
Wake Forest University Health Sciences
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 urinary catheter removal and Urinary catheter removal on POD 3 in people with Urinary Retention Postoperative, run by Wake Forest University Health Sciences 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 1 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: stopped early, as of the sponsor's last update on 6 May 2023. 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 was stopped early (reason given: Low recruitment and attrition of study personnel). Results are not available in the source record.
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?
Percentage of patients requiring re-insertion of a transurethral urinary catheter (time frame: 7 days). 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 6 May 2023.