Spinal Cord Injuries (SCI)NCT06978205
Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
A study testing Urethral Balloon Dilation, intermittent catheterization and Acupuncture treatment in people with Spinal Cord Injuries (SCI) and Urinary Bladder, Neurogenic, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Trial Objectives: This clinical trial aims to explore whether ultrasound - guided urethral balloon dilation can effectively improve the micturition function of patients with urinary retention after spinal cord injury, and to evaluate the safety of this treatment method. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries (SCI), Urinary Bladder, Neurogenic, Urinary Retention
- What is being tested?
- Urethral Balloon Dilation, intermittent catheterization and Acupuncture treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-80 years old
- There is a confirmed diagnosis report of CT or MRI imaging, with the first diagnosis being spinal cord injury (complete or incomplete), which conforms to the International Classification of Spinal Cord Injury Neurology published by the American Spinal Injury Association (ASIA) in 2013
- The spinal shock period has passed, and consciousness is clear with stable vital signs
- In line with the diagnostic criteria of urinary retention and in combination with clinical practice: the patient can urinate autonomously before spinal cord injury, which is confirmed as spinal cord injury by clinical examination. It is manifested as retention of urine after spinal cord injury, swelling of lower abdomen, filling of bladder, dullness on percussion, residual urine volume of bladder B ultrasonic examination is more than 300ml, which shows that urination is laborious
- Urodynamic examination shows maximum urethral pressure greater than 50cmH2O
- No tumors or benign prostatic hyperplasia were found
- Patients who have had their indwelling urinary catheter removed
- Voluntary participation in research and signing of informed consent form
Who cannot join
- Patients with severe heart, brain, lung and other important organ diseases or mental and cognitive disorders
- Individuals with disrupted water electrolyte and acid-base balance
- There are serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy and other diseases
- There is a urinary system infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hui Wei
Jinan, Shandong, 250012
Hui Wei, 18560083563, 83926275@qq.com
Fuchao Yao, yaofuchao2023@163.com
About this study
Trial Objectives: This clinical trial aims to explore whether ultrasound - guided urethral balloon dilation can effectively improve the micturition function of patients with urinary retention after spinal cord injury, and to evaluate the safety of this treatment method. The main questions it attempts to answer are:
Can ultrasound - guided urethral balloon dilation reduce the residual urine volume and improve the quality of life of patients with urinary retention after spinal cord injury? Trial Design: Researchers will compare the group receiving ultrasound - guided urethral balloon dilation combined with conventional rehabilitation therapy (the experimental group) with the group receiving only conventional rehabilitation therapy (the control group) to determine the therapeutic effect of ultrasound - guided urethral balloon dilation on urinary retention after spinal cord injury.
Read more
Tasks for Participants:
Participants in the experimental group will receive ultrasound - guided urethral balloon dilation and cooperate with conventional rehabilitation therapy (including acupuncture therapy, pelvic floor biofeedback electrical stimulation, and pelvic floor function training). Participants in the control group will receive only conventional rehabilitation therapy for a period of 1 - 2 weeks.
During the intervention, patients are required to strictly record a micturition diary under the guidance of researchers or medical staff. The diary should cover details such as daily spontaneous urine output, daily catheterized urine output, daily urine leakage volume, and daily frequency of catheterization.
Residual urine volume will be detected every day for three days before the intervention and three days after the intervention.
Read the detailed description
Standard Rehabilitation Treatment (Control Group)：Participants in the control group will receive conventional rehabilitation therapy: Pelvic floor muscle training and Biofeedback electrical stimulation.
Urethral Balloon Dilation (Intervention Group)：Participants in the intervention group will receive urethral balloon dilation in addition to standard rehabilitation therapy. The specific procedures are as follows:
- A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn.
- Ultrasound imaging will be used to precisely locate the external urethral sphincter.
- The catheter will be fully lubricated and gently inserted into the urethra.
- Under real-time ultrasound guidance, 2-3.5 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter.
- Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed.
- After treatment, the balloon will be fully deflated, and the catheter will be carefully removed.
This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment). Each session lasts 5 minutes. Strict aseptic techniques will be followed. The procedure will be conducted by experienced physicians under ultrasound guidance to ensure maximum safety and effectiveness.
- Being tested
- Urethral Balloon Dilation, intermittent catheterization, Acupuncture treatment, Pelvic floor function training
- Keywords
- Spinal Cord Injuries, neurogenic bladder, urinary retention, Urethral balloon dilation, zelen design, Randomized controlled clinical trial
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urethral Balloon DilationDevice
Urethral balloon dilation + conventional rehabilitation therapy. 1.A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn. 2.Ultrasound imaging will be used to precisely locate the external urethral sphincter. 3.The catheter will be fully lubricated and gently inserted into the urethra. 4.Under real-time ultrasound guidance, 2-4 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter. 5.Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed. This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment）Each session lasts 5 minutes. Strict aseptic techniques will be followed.
intermittent catheterizationDevice
Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine.
Acupuncture treatmentDevice
Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints.
Pelvic floor function trainingBehavioural
The pelvic floor therapist assesses the patient's pelvic floor muscle condition and guides the patient to perform effective pelvic floor muscle contractions and relaxations.
| Study group | Role | What they receive |
|---|---|---|
| conventional rehabilitation treatment. | Active comparator | Conventional rehabilitation treatment methods include intermittent catheterization, acupuncture and pelvic floor function training. Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine. Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints once a day, 5 days a week, for a total of 1-2 weeks. The pelvic floor therapist assesses the patient's pelvic floor muscle condition and guides the patient to perform effective pelvic floor muscle contractions and relaxations. Receives: Device: intermittent catheterization; Device: Acupuncture treatment; Behavioral: Pelvic floor function training |
| Urethral Balloon Dilation | Experimental | 1.A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn. 2.Ultrasound imaging will be used to precisely locate the external urethral sphincter. 3.The catheter will be fully lubricated and gently inserted into the urethra. 4.Under real-time ultrasound guidance, 2-4 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter. 5.Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed. This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment）Each session lasts 5 minutes. Strict aseptic techniques will be followed. Receives: Device: Urethral Balloon Dilation; Device: intermittent catheterization; Device: Acupuncture treatment; Behavioral: Pelvic floor function training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual urine volume
Use a bladder capacity measuring instrument (model HD5, produced by Liaoning Hande Technology Co., Ltd.) to perform ultrasound testing on patients after urination and record residual urine volume.
Measured: Before treatment and three consecutive days after treatment
Voiding Diary
Under the supervision of researchers and medical staff, patients were instructed to keep a urinary diary during hospitalization (including catheterization time, spontaneous displacement, catheterization volume, and catheterization frequency)
Measured: Before treatment and three consecutive days after treatment
Secondary outcomes (4)
Short-Form Health Survey-Qualiveen (SF-Qualiveen)
For the assessment of patients' quality of life, the SF Qualiveen Quality of Life Scale score was used.The scale includes 4 dimensions and 8 items of annoyance (items 1~2), restriction (items 3~4), fear (items 5~6), and feeling (items 7~8). Each item was scored by Likert 5 grades, in which item 3 was assigned a score of "never", "rarely", "sometimes", "often" and "always", and the rest of the items were assigned 0~4 points according to "none", "a little", "moderate", "quite severe" and "extremely severe", the score of each dimension was the mean of each item within the dimension, and the score of the scale was the average score of each dimension, with a total score of 0~4 points, the lower the score, the better the quality of life of patients.
Measured: Before treatment and on the third day after treatment
Neurogenic Bladder Symptom Score (NBSS)
The NBSS Neurogenic Bladder Symptom Rating Scale was used to score the patient's urinary symptoms.The NBSS scale consists of 24 items assessing three key dimensions: urinary incontinence (8 items, 0-29 points), bladder storage and voiding function (7 items, 0-22 points), urinary tract complications (7 items, 0-23 points). Additionally, two non-scoring items assess bladder management methods and overall quality of life. Each item is scored from 0 to 3 or 0 to 4, with higher scores indicating more severe bladder symptoms.
Measured: Before treatment and on the third day after treatment
Core Lower Urinary Tract Symptom Rating Scale
CLSS will be used to evaluate lower urinary tract symptoms before and after treatment. The total score ranges from 0 to 30: 0 points = No symptoms, 1 point = Rare symptoms, 2 points = Occasional symptoms, 3 points = Frequent symptoms, Lower CLSS scores indicate greater symptom improvement following treatment
Measured: Before treatment and on the third day after treatment
Hospital Anxiety and Depression Scale (HADS)
The HADS was developed by Zigmond AS and Snaith RP in 1983 for screening anxiety and depression in hospitalized patients[36]. The scale consists of 14 items, divided into: 7 items for depression assessment, 7 items for anxiety assessment, The Chinese version of HADS has demonstrated strong reliability and validity, making it an effective tool for assessing psychological well-being in clinical settings
Measured: Before treatment and on the third day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start28 Apr 2025
- Primary completion27 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978205
- Sponsor's protocol ID
- KYLL-202503-011-1
- Status last verified
- Apr 2025
- First submitted
- 5 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06978205
- Acronym / sponsor ID
- KYLL-202503-011-1
- Keywords
- Spinal Cord Injuries, neurogenic bladder, urinary retention, Urethral balloon dilation, zelen design, Randomized controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 27 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 May 2025 (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.
Trial Objectives: This clinical trial aims to explore whether ultrasound - guided urethral balloon dilation can effectively improve the micturition function of patients with urinary retention after spinal cord injury, and to evaluate the safety of this treatment method. The main questions it attempts to answer are:
Can ultrasound - guided urethral balloon dilation reduce the residual urine volume and improve the quality of life of patients with urinary retention after spinal cord injury? Trial Design: Researchers will compare the group receiving ultrasound - guided urethral balloon dilation combined with conventional rehabilitation therapy (the experimental group) with the group receiving only conventional rehabilitation therapy (the control group) to determine the therapeutic effect of ultrasound - guided urethral balloon dilation on urinary retention after spinal cord injury.
Tasks for Participants:
Participants in the experimental group will receive ultrasound - guided urethral balloon dilation and cooperate with conventional rehabilitation therapy (including acupuncture therapy, pelvic floor biofeedback electrical stimulation, and pelvic floor function training). Participants in the control group will receive only conventional rehabilitation therapy for a period of 1 - 2 weeks.
During the intervention, patients are required to strictly record a micturition diary under the guidance of researchers or medical staff. The diary should cover details such as daily spontaneous urine output, daily catheterized urine output, daily urine leakage volume, and daily frequency of catheterization.
Residual urine volume will be detected every day for three days before the intervention and three days after the intervention.
Detailed description
Standard Rehabilitation Treatment (Control Group)：Participants in the control group will receive conventional rehabilitation therapy: Pelvic floor muscle training and Biofeedback electrical stimulation.
Urethral Balloon Dilation (Intervention Group)：Participants in the intervention group will receive urethral balloon dilation in addition to standard rehabilitation therapy. The specific procedures are as follows:
- A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn.
- Ultrasound imaging will be used to precisely locate the external urethral sphincter.
- The catheter will be fully lubricated and gently inserted into the urethra.
- Under real-time ultrasound guidance, 2-3.5 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter.
- Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed.
- After treatment, the balloon will be fully deflated, and the catheter will be carefully removed.
This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment). Each session lasts 5 minutes. Strict aseptic techniques will be followed. The procedure will be conducted by experienced physicians under ultrasound guidance to ensure maximum safety and effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional rehabilitation treatment. | Active comparator | Device: intermittent catheterization, Device: Acupuncture treatment, Behavioral: Pelvic floor function trainingConventional rehabilitation treatment methods include intermittent catheterization, acupuncture and pelvic floor function training. Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine. Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints once a day, 5 days a week, for a total of 1-2 weeks. The pelvic floor therapist assesses the patient's pelvic floor muscle condition and guides the patient to perform effective pelvic floor muscle contractions and relaxations. |
| Urethral Balloon Dilation | Experimental | Device: Urethral Balloon Dilation, Device: intermittent catheterization, Device: Acupuncture treatment, Behavioral: Pelvic floor function training1.A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn. 2.Ultrasound imaging will be used to precisely locate the external urethral sphincter. 3.The catheter will be fully lubricated and gently inserted into the urethra. 4.Under real-time ultrasound guidance, 2-4 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter. 5.Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed. This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment）Each session lasts 5 minutes. Strict aseptic techniques will be followed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18-80 years old
- There is a confirmed diagnosis report of CT or MRI imaging, with the first diagnosis being spinal cord injury (complete or incomplete), which conforms to the International Classification of Spinal Cord Injury Neurology published by the American Spinal Injury Association (ASIA) in 2013
- The spinal shock period has passed, and consciousness is clear with stable vital signs
- In line with the diagnostic criteria of urinary retention and in combination with clinical practice: the patient can urinate autonomously before spinal cord injury, which is confirmed as spinal cord injury by clinical examination. It is manifested as retention of urine after spinal cord injury, swelling of lower abdomen, filling of bladder, dullness on percussion, residual urine volume of bladder B ultrasonic examination is more than 300ml, which shows that urination is laborious
- Urodynamic examination shows maximum urethral pressure greater than 50cmH2O
Key exclusion criteria (4 listed)
- Patients with severe heart, brain, lung and other important organ diseases or mental and cognitive disorders
- Individuals with disrupted water electrolyte and acid-base balance
- There are serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy and other diseases
- There is a urinary system infection
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 |
|---|---|---|
| Urethral Balloon DilationUrethral balloon dilation + conventional rehabilitation therapy. 1.A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn. 2.Ultrasound imaging will be used to precisely locate the external urethral sphincter. 3.The catheter will be fully lubricated and gently inserted into the urethra. 4.Under real-time ultrasound guidance, 2-4 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter. 5.Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed. This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment）Each session lasts 5 minutes. Strict aseptic techniques will be followed. | Device | Urethral Balloon Dilation |
| intermittent catheterizationIntermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine. | Device | Urethral Balloon Dilation, conventional rehabilitation treatment. |
| Acupuncture treatmentAcupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints. | Device | Urethral Balloon Dilation, conventional rehabilitation treatment. |
| Pelvic floor function trainingThe pelvic floor therapist assesses the patient's pelvic floor muscle condition and guides the patient to perform effective pelvic floor muscle contractions and relaxations. | Behavioural | Urethral Balloon Dilation, conventional rehabilitation treatment. |
Primary outcome
Residual urine volume
Time frame: Before treatment and three consecutive days after treatment
Use a bladder capacity measuring instrument (model HD5, produced by Liaoning Hande Technology Co., Ltd.) to perform ultrasound testing on patients after urination and record residual urine volume.
Voiding Diary
Time frame: Before treatment and three consecutive days after treatment
Under the supervision of researchers and medical staff, patients were instructed to keep a urinary diary during hospitalization (including catheterization time, spontaneous displacement, catheterization volume, and catheterization frequency)
4 secondary outcomes
Short-Form Health Survey-Qualiveen (SF-Qualiveen)
Time frame: Before treatment and on the third day after treatment
Neurogenic Bladder Symptom Score (NBSS)
Time frame: Before treatment and on the third day after treatment
Core Lower Urinary Tract Symptom Rating Scale
Time frame: Before treatment and on the third day after treatment
Hospital Anxiety and Depression Scale (HADS)
Time frame: Before treatment and on the third day after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urethral Balloon Dilation, intermittent catheterization and Acupuncture treatment in people with Spinal Cord Injuries (SCI) and Urinary Bladder, Neurogenic, run by Qilu Hospital of Shandong University at 1 site in China.
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 8 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: looking for participants now, as of the sponsor's last update on 18 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Wei (18560083563, 83926275@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual urine volume (time frame: Before treatment and three consecutive days after treatment). The study lists 2 primary outcomes in all. 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 18 May 2025.