Postoperative Urinary RetentionNCT05428020
RCT Foley Catheter Study for Elective TJA
A study testing Indwelling foley catheter and No foley catheter in people with Postoperative Urinary Retention and Total Hip Arthroplasty, run by Rush University Medical Center at 1 site in United States.
Trial summary
Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Urinary Retention, Total Hip Arthroplasty, Total Knee Arthroplasty
- What is being tested?
- Indwelling foley catheter and No foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient >18 years of age scheduled for an inpatient primary hip or knee replacement
Who cannot join
- Patients with a known history of prostate, urological or kidney surgery
- Patients where close monitoring of urine output are necessary during the perioperative period (renal disease, renal failure, chronic indwelling urinary catheter)
- Patients with a history of urinary incontinence
- Patients undergoing a revision total knee or total hip arthroplasty
- Patients requiring indwelling continuous epidural anesthesia
- Patients with a preexisting urinary tract infection, as diagnosed on preoperative screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University medical Center
Chicago, Illinois, 60612
About this study
Official title: The Use of a Routine Indwelling Urinary Catheter in Patients Receiving Neuraxial Anesthesia for Elective Total Joint Arthroplasty
Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension. Urinary retention is associated with adverse events including bladder atony, increased post void residuals, and postoperative urinary tract infection. Treatment of urinary retention involves intermittent or indwelling urinary catheter placement, both of which are associated with an increased prevalence of postoperative urinary tract infection.
There currently is no consensus whether the use of a urinary catheter in elective joint arthroplasty with neuraxial anesthesia decreases the risk of urinary retention. The prevalence of retention reported in the literature varies widely with reports anywhere from 0% to 75% in patients with early removal of a catheter or after procedures performed without a catheter.
The goal of this study is to determine whether the routine use of an indwelling urinary catheter decreases the rate of postoperative urinary retention in patients undergoing elective joint arthroplasty.
Read the detailed description
Study Design
Treatment Groups:
Group 1 (Control): Short term urinary catheter- Patient will receive a urinary catheter at the time of the surgery. The urinary catheter will be removed upon arrival to the orthopedic floor post operatively. Patients will subsequently be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol.
Group 2 (Experimental): No urinary catheter- Patients will not receive a urinary catheter at time of surgery. They will be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol
Sample Size Calculation Based on a randomized controlled trial published by Miller et al in 2013, to detect a clinically significant difference of 7%, we would need 194 patients per group, or 388 patients. Assuming a drop-out rate of 10%, a total of 432 patients will be required. An interim analysis will be performed once half of this total is enrolled.
Urinary retention protocol:
Patients will be monitored closely for urinary retention according to current Rush University Medical Center Urinary Retention Protocol. After removal of catheter (control group) or from arrival in post-anesthesia care unit (experimental group), patients will be given 4 hours to void a volume corresponding to 30ml/hour. If the patient fails to do so, they will be bladder scanned. Bladder scan results of 450ml or greater will result in one time straight catheterization. If bladder scan shows 150 ml to 349 ml of urine, patients will be given an additional 4 hours to void and a repeat bladder scan will be performed. If unable to void at this point and/or bladder volume is >450, patient will receive a one time straight catheterization.
If bladder scan shows 350 ml to 449 ml of urine, patients will be given an additional 2 hours to void and a repeat bladder scan performed. If unable to void at this point and/or bladder volume is >450, patient will receive a one time straight catheterization.
If patients require a straight catheterization, they will be monitored with bladder scan according to protocol and a second straight catheterization will be performed if necessary. At time of second straight catheterization, a urinalysis will be sent. If patient requires a third straight catheterization, a urology consult will be placed according to protocol and patient will either receive an indwelling urinary catheter or intermittent straight catheterization with urology follow up.
Demographics, Patient Specifics Age, sex, short form 12 scores, american society of anesthesia (ASA) score, medical co-morbidities, weight, height, length of hospitalization, BMI, history of benign prostatic hypertrophy, presence of preoperative urinary tract infection (diagnosed during preadmission testing), intravenous fluids given during surgery, operating room time, estimated blood loss, length of hospital stay, discharge destination (home versus rehabilitation facility), time to mobilization postoperatively, and length of urinary catheter usage.
At the time of enrollment in the study, patients will be given a urinary history questionnaire known as the International Prostate Symptom Score (I-PSS) and be asked about history of urinary retention, history of incontinence, and history of polyuria to screen for preexisting urinary issues. Patients will receive a urinalysis as part of preoperative testing to screen for presence of urinary tract infection. Patients will receive standardized multimodal analgesic regimen that is utilized at Rush University Medical Center for patients undergoing a total joint replacement for perioperative and postoperative pain management. Modifications will be made on a case by case basis as is currently the standard practice (for example, allergy, intolerance, or medical contraindication such as acute kidney injury to NSAID use)
- Being tested
- Indwelling foley catheter, No foley catheter
- Keywords
- total knee arthroplasty, total hip arthroplasty, indwelling catheter, Foley catheter, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling foley catheterDevice
Also called foley
short-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery).
No foley catheterOther
No foley catheter is placed for surgery
| Study group | Role | What they receive |
|---|---|---|
| Indwelling foley catheter | Experimental | Short-term indwelling foley catheter Receives: Device: Indwelling foley catheter |
| No Foley catheter | Placebo comparator | No foley catheter Receives: Other: No foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr
All patients were monitored per hospital protocol for urinary retention. After removal of catheter (control group) and those without (experimental group) upon arrival in the PACU (post anesthesia care unit), patients were given 4 hours to void a volume corresponding to 30ml/hour. If the patient failed to do so, they would have their bladder scanned. Bladder scanned results were all reported by 4 hours after surgery. Patients inability to void a volume corresponding to 30ml/hour AND after straight catheterization (per hospital protocol), meant they developed POUR following surgery.
Measured: While inpatient following surgery
Secondary outcomes (2)
Urinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty
Patients who are treated following Total Joint Arthroplasty for UTI
Measured: up to 3 weeks after surgery
Straight Catheterization Required While Inpatient Following Total Joint Arthroplasty
Patient requires 1 or more straight catheterization while inpatient, due to inability to void 30ml/hr during the patient's hospital stay. Straight catheterizations are performed by placing an indwelling catheter when indicated by retention of ≥450 mL on bladder scans. Bladder scans are performed per hospital protocol for patients unable to void a volume of 30ml/hr in the first 4 hours following surgery. If bladder shows 150 ml to 349 ml of urine, patients are given another 4 hours to void, followed by a repeat bladder scan. If unable to void at that time, or bladder volume is >450ml, patient will receive one-time catheterization.
If bladder scan shows 350 ml to 449 ml of urine, they will be given 2 hours to void and repeat bladder scan. If unable to void or bladder volume is >450 ml, patient receives one time catheterization.
If patient receives straight catheterization, they're monitored according to protocol and a second straight catheterization is done if necessary.
Measured: While inpatient at hospital, immediately following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start16 Nov 2020
- Primary completion25 May 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Urinary RetentionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig J Della Valle, MD, Rush University Medical Center
- Investigators
- Craig Della Valle, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428020
- Sponsor's protocol ID
- 19123101
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2022
- Last updated
- 3 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Abstract and Manuscript write up upon completion of study
Publications
Balderi T, Carli F. Urinary retention after total hip and knee arthroplasty. Minerva Anestesiol. 2010 Feb;76(2):120-30.
PubMed 20150853Lo E, Nicolle L, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Marschall J, Mermel LA, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S41-50. doi: 10.1086/591066. No abstract available.
PubMed 18840088Farag E, Dilger J, Brooks P, Tetzlaff JE. Epidural analgesia improves early rehabilitation after total knee replacement. J Clin Anesth. 2005 Jun;17(4):281-5. doi: 10.1016/j.jclinane.2004.08.008.
PubMed 15950853Borghi B, Agnoletti V, Ricci A, van Oven H, Montone N, Casati A. A prospective, randomized evaluation of the effects of epidural needle rotation on the distribution of epidural block. Anesth Analg. 2004 May;98(5):1473-8, table of contents. doi: 10.1213/01.ane.0000111113.45743.b8.
PubMed 15105234Miller AG, McKenzie J, Greenky M, Shaw E, Gandhi K, Hozack WJ, Parvizi J. Spinal anesthesia: should everyone receive a urinary catheter?: a randomized, prospective study of patients undergoing total hip arthroplasty. J Bone Joint Surg Am. 2013 Aug 21;95(16):1498-503. doi: 10.2106/JBJS.K.01671.
PubMed 23965700Anger J, Lee U, Ackerman AL, Chou R, Chughtai B, Clemens JQ, Hickling D, Kapoor A, Kenton KS, Kaufman MR, Rondanina MA, Stapleton A, Stothers L, Chai TC. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. 2019 Aug;202(2):282-289. doi: 10.1097/JU.0000000000000296. Epub 2019 Jul 8.
PubMed 31042112Darbyshire D, Rowbotham D, Grayson S, Taylor J, Shackley D. Surveying patients about their experience with a urinary catheter. Int J of Uro Nursing 2016;10(1):14-20.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Routine Indwelling Urinary Catheter in Patients Receiving Neuraxial Anesthesia for Elective Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT05428020
- Acronym / sponsor ID
- 19123101
- Keywords
- total knee arthroplasty, total hip arthroplasty, indwelling catheter, Foley catheter, arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Posted 3 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension. Urinary retention is associated with adverse events including bladder atony, increased post void residuals, and postoperative urinary tract infection. Treatment of urinary retention involves intermittent or indwelling urinary catheter placement, both of which are associated with an increased prevalence of postoperative urinary tract infection.
There currently is no consensus whether the use of a urinary catheter in elective joint arthroplasty with neuraxial anesthesia decreases the risk of urinary retention. The prevalence of retention reported in the literature varies widely with reports anywhere from 0% to 75% in patients with early removal of a catheter or after procedures performed without a catheter.
The goal of this study is to determine whether the routine use of an indwelling urinary catheter decreases the rate of postoperative urinary retention in patients undergoing elective joint arthroplasty.
Detailed description
Study Design
Treatment Groups:
Group 1 (Control): Short term urinary catheter- Patient will receive a urinary catheter at the time of the surgery. The urinary catheter will be removed upon arrival to the orthopedic floor post operatively. Patients will subsequently be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol.
Group 2 (Experimental): No urinary catheter- Patients will not receive a urinary catheter at time of surgery. They will be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol
Sample Size Calculation Based on a randomized controlled trial published by Miller et al in 2013, to detect a clinically significant difference of 7%, we would need 194 patients per group, or 388 patients. Assuming a drop-out rate of 10%, a total of 432 patients will be required. An interim analysis will be performed once half of this total is enrolled.
Urinary retention protocol:
Patients will be monitored closely for urinary retention according to current Rush University Medical Center Urinary Retention Protocol. After removal of catheter (control group) or from arrival in post-anesthesia care unit (experimental group), patients will be given 4 hours to void a volume corresponding to 30ml/hour. If the patient fails to do so, they will be bladder scanned. Bladder scan results of 450ml or greater will result in one time straight catheterization. If bladder scan shows 150 ml to 349 ml of urine, patients will be given an additional 4 hours to void and a repeat bladder scan will be performed. If unable to void at this point and/or bladder volume is >450, patient will receive a one time straight catheterization.
If bladder scan shows 350 ml to 449 ml of urine, patients will be given an additional 2 hours to void and a repeat bladder scan performed. If unable to void at this point and/or bladder volume is >450, patient will receive a one time straight catheterization.
If patients require a straight catheterization, they will be monitored with bladder scan according to protocol and a second straight catheterization will be performed if necessary. At time of second straight catheterization, a urinalysis will be sent. If patient requires a third straight catheterization, a urology consult will be placed according to protocol and patient will either receive an indwelling urinary catheter or intermittent straight catheterization with urology follow up.
Demographics, Patient Specifics Age, sex, short form 12 scores, american society of anesthesia (ASA) score, medical co-morbidities, weight, height, length of hospitalization, BMI, history of benign prostatic hypertrophy, presence of preoperative urinary tract infection (diagnosed during preadmission testing), intravenous fluids given during surgery, operating room time, estimated blood loss, length of hospital stay, discharge destination (home versus rehabilitation facility), time to mobilization postoperatively, and length of urinary catheter usage.
At the time of enrollment in the study, patients will be given a urinary history questionnaire known as the International Prostate Symptom Score (I-PSS) and be asked about history of urinary retention, history of incontinence, and history of polyuria to screen for preexisting urinary issues. Patients will receive a urinalysis as part of preoperative testing to screen for presence of urinary tract infection. Patients will receive standardized multimodal analgesic regimen that is utilized at Rush University Medical Center for patients undergoing a total joint replacement for perioperative and postoperative pain management. Modifications will be made on a case by case basis as is currently the standard practice (for example, allergy, intolerance, or medical contraindication such as acute kidney injury to NSAID use)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indwelling foley catheter | Experimental | Device: Indwelling foley catheterShort-term indwelling foley catheter |
| No Foley catheter | Placebo comparator | Other: No foley catheterNo foley catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient >18 years of age scheduled for an inpatient primary hip or knee replacement
Key exclusion criteria (6 listed)
- Patients with a known history of prostate, urological or kidney surgery
- Patients where close monitoring of urine output are necessary during the perioperative period (renal disease, renal failure, chronic indwelling urinary catheter)
- Patients with a history of urinary incontinence
- Patients undergoing a revision total knee or total hip arthroplasty
- Patients requiring indwelling continuous epidural anesthesia
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 |
|---|---|---|
| Indwelling foley catheterAlso: foleyshort-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery). | Device | Indwelling foley catheter |
| No foley catheterNo foley catheter is placed for surgery | Other | No Foley catheter |
Primary outcome
Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr
Time frame: While inpatient following surgery
All patients were monitored per hospital protocol for urinary retention. After removal of catheter (control group) and those without (experimental group) upon arrival in the PACU (post anesthesia care unit), patients were given 4 hours to void a volume corresponding to 30ml/hour. If the patient failed to do so, they would have their bladder scanned. Bladder scanned results were all reported by 4 hours after surgery. Patients inability to void a volume corresponding to 30ml/hour AND after straight catheterization (per hospital protocol), meant they developed POUR following surgery.
2 secondary outcomes
Urinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty
Time frame: up to 3 weeks after surgery
Straight Catheterization Required While Inpatient Following Total Joint Arthroplasty
Time frame: While inpatient at hospital, immediately following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20150853Balderi T, Carli F. Urinary retention after total hip and knee arthroplasty. Minerva Anestesiol. 2010 Feb;76(2):120-30.
- Background: PubMed 18840088Lo E, Nicolle L, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Marschall J, Mermel LA, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S41-50. doi: 10.1086/591066. No abstract available.
- Background: PubMed 15950853Farag E, Dilger J, Brooks P, Tetzlaff JE. Epidural analgesia improves early rehabilitation after total knee replacement. J Clin Anesth. 2005 Jun;17(4):281-5. doi: 10.1016/j.jclinane.2004.08.008.
- Background: PubMed 15105234Borghi B, Agnoletti V, Ricci A, van Oven H, Montone N, Casati A. A prospective, randomized evaluation of the effects of epidural needle rotation on the distribution of epidural block. Anesth Analg. 2004 May;98(5):1473-8, table of contents. doi: 10.1213/01.ane.0000111113.45743.b8.
- Background: PubMed 23965700Miller AG, McKenzie J, Greenky M, Shaw E, Gandhi K, Hozack WJ, Parvizi J. Spinal anesthesia: should everyone receive a urinary catheter?: a randomized, prospective study of patients undergoing total hip arthroplasty. J Bone Joint Surg Am. 2013 Aug 21;95(16):1498-503. doi: 10.2106/JBJS.K.01671.
- Background: PubMed 31042112Anger J, Lee U, Ackerman AL, Chou R, Chughtai B, Clemens JQ, Hickling D, Kapoor A, Kenton KS, Kaufman MR, Rondanina MA, Stapleton A, Stothers L, Chai TC. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. 2019 Aug;202(2):282-289. doi: 10.1097/JU.0000000000000296. Epub 2019 Jul 8.
- BackgroundDarbyshire D, Rowbotham D, Grayson S, Taylor J, Shackley D. Surveying patients about their experience with a urinary catheter. Int J of Uro Nursing 2016;10(1):14-20.
- Individual participant dataSharing planned: No. Abstract and Manuscript write up upon completion of study
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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.
Craig Della Valle, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indwelling foley catheter and No foley catheter in people with Postoperative Urinary Retention and Total Hip Arthroplasty, run by Rush University Medical Center 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 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 3 Aug 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr (time frame: While inpatient following surgery). 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 NCT05428020, which also lists 7 linked publications.
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 3 Aug 2023.