Lower Urinary Tract SymptomsNCT06251557
Core Massage and Exercise in Pediatric LUTD
A study testing Massage Therapy, Exercise Training and Pelvic Floor Electromyography (EMG) Biofeedback Therapy in people with Lower Urinary Tract Symptoms, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Lower urinary tract dysfunctions (LUTD) are common in the pediatric population and include symptoms related to functional disorders. LUTD limits children and their parents socially, physically, and financially; leads to secondary comorbidities in the long term and negatively affects quality of life. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Massage Therapy, Exercise Training and Pelvic Floor Electromyography (EMG) Biofeedback Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2024to 16 Mar 2026
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 7 and 15
- Presence of symptoms of functional lower urinary tract dysfunction
- Do not have a condition (such as autism, ADHD-Attention Deficit and Hyperactivity Disorder) that would prevent cooperation with the assessments and interventions in the study
- Consented to participate in the study by their parents
Who cannot join
- Symptomatic urinary tract infection,
- A neurological disease,
- Neurogenic bladder/bowel diagnosis,
- Monosymptomatic enuresis,
- Anatomical anomaly that may affect bladder/bowel function,
- Fecal incontinence,
- Disruption of skin integrity or open wound at the massage site and
- An orthopedic problem that would prevent them from performing the exercises in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Core-Based Massage and Exercise Training in Children With Lower Urinary Tract Dysfunction: A Randomized Controlled Trial
Lower urinary tract dysfunctions (LUTD) are common in the pediatric population and include symptoms related to functional disorders. LUTD limits children and their parents socially, physically, and financially; leads to secondary comorbidities in the long term and negatively affects quality of life. Therefore, effective treatment of LUTD is important. Treatment options in children with LUTD include standard urotherapy, physiotherapy and rehabilitation practices, pharmacologic approaches, and Botulinum toxin type A injections. Pharmacologic treatment and invasive approaches have high side effect rates and compliance problems; therefore, conservative treatment methods should be completed first. The literature focuses on standard urotherapy, pharmacologic approaches and biofeedback therapy. However, standard urotherapy and biofeedback are first-line treatments for pediatric LUTD, but their success rates are often limited. In addition, the pelvic floor contributes to abdomino-lumbopelvic stability and works in synergy with diaphragm, deep abdominal muscles and spinal segments. To the best of our knowledge, there is no study in this population that comprehensively addresses the anatomical structures closely related to the pelvic floor with a more holistic perspective beyond the standard patient education and pelvic floor. Therefore, The aim of our study is to demonstrate the additional effects of core-based massage and exercise training in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design.
Read the detailed description
Pediatric lower urinary tract dysfunction (LUTD) is a common and multifactorial health problem. A holistic perspective is required in treatment. Therefore, the aim of our study is to demonstrate the additional effects of massage therapy and exercise training for the abdomino-lumbopelvic area in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design. At the beginning of our study, sample size was estimated using the G Power 3.1.9.7 program. To detect a clinically significant difference of 30% between the groups (80% improvement in the research arm and 50% in the control arm) with 80% power and an alpha level of 0.05 based on a one-sided hypothesis, the minimum sample size was determined to be 42 participants, with 21 allocated to each group. The study will include 42 volunteer children aged 7-15 years with symptoms associated with functional LUTD, accompanied by their parents. Children will be randomly assigned to 2 separate groups according to an online computer generated, gender stratified block randomization list. Group 1 will receive core-based massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy. Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy. The treatments will be applied 2 days a week for 6 weeks. Children will be evaluated at the beginning of the study and at the end of the treatment (6th week). The primary outcome measure is the "Dysfunctional Voiding and Incontinence Score". Secondary outcome measures are 3-day voiding and defecation diaries data, uroflowmetry parameters, residual urine volume after voiding by pelvic ultrasound and physical fitness parameters. SPSS program will be used for data analysis. In the comparison of numerical data between 2 independent groups, "Independent Groups T Test" will be used when parametric assumptions are met and "Mann-Whitney U test" will be used when parametric assumptions are not met. In the analysis of change within the dependent group, "Significance Test of the Difference Between Two Pairs" will be used when parametric assumptions are met and "Wilcoxon Test" will be used when parametric assumptions are not met. In the examination of the change in outcome measurements over time, the effect of the treatments in both groups on the dependent variables in all evaluations (In-group factor, Time; pre-treatment and post-treatment) will be tested with "Repeated Measures of Anova" using Treatment Group*Time (2*2) factors. Type-1 error level for statistical significance will be based on 5%.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Massage Therapy, Exercise Training, Pelvic Floor Electromyography (EMG) Biofeedback Therapy, Standard Urotherapy
- Keywords
- Children, Biofeedback therapy, Urotherapy, core-based exercise, massage
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyOther
10 minutes abdominal massage and 10 minutes lower back massage will be applied in each session. It will take 20 minutes in total.
Exercise TrainingOther
Exercise training will last approximately 10 minutes in each session. In the exercise training, lumbopelvic stabilization exercises (bridge, cat-and-cow and squatting exercises) will be performed for 10 repetitions, lumbopelvic flexibility exercises (child position, happy baby position, adductor muscle stretching, psoas muscle stretching) will be performed for 20 seconds and 5 repetitions, and diaphragmatic breathing exercises will be performed for 5 repetitions in supine, side lying and sitting positions.
Pelvic Floor Electromyography (EMG) Biofeedback TherapyDevice
Biofeedback therapy will be applied for 20 minutes in each session. During the application, adhesive surface electrodes will be placed on the perineum at 3 o'clock and 9 o'clock for each child. Through these electrodes, the activity signals of the muscles in that area will be recorded superficially. By monitoring the regional muscle activity, feedback is provided to increase and/or decrease the activity according to the activity pattern. As a result, pelvic floor biofeedback therapy will teach the child the correct use of the pelvic floor muscles. During the session, pelvic floor awareness and relaxation exercises specific to the child will be practiced with visual animations.
Standard UrotherapyBehavioural
The anatomy of the urinary system and related structures, the causes of voiding dysfunction and symptoms will be explained to the family and the child with visuals. A written form including timed voiding during the day, appropriate fluid intake, correct toilet posture, adequate and balanced nutrition will be given.
| Study group | Role | What they receive |
|---|---|---|
| Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy | Experimental | Group 1 will receive abdomino-lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy. Receives: Other: Massage Therapy; Other: Exercise Training; Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy; Behavioral: Standard Urotherapy |
| Standard Urotherapy and Biofeedback Therapy | Active comparator | Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy. Receives: Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy; Behavioral: Standard Urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score
Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire will be used to evaluate the symptom score.
Measured: Change in symptom score from baseline up to end of 6th week
Secondary outcomes (8)
Frequency of voiding and incontinence
3-day voiding diary will be used to evaluate the frequency of voiding, incontinence and defecation.
Measured: Change in frequency of voiding, incontinence and defecation from baseline up to end of 6th week
Maximum and mean voided volumes
3-day voiding diary will be used to evaluate the maximum and mean voided volumes (ml)
Measured: Change in maximum and mean voided volumes (ml) from baseline up to end of 6th week
Uroflowmeter parameters- Maximum Flow Rate
Uroflowmeter test report will be used to evaluate the maximum flow rate (ml/sn)
Measured: Change in uroflowmeter parameters from baseline up to end of 6th week
Uroflowmeter parameters- Curve Type
Uroflowmeter test report will be used to record flow curve type.
Measured: Change in uroflowmeter curve type from baseline up to end of 6th week
Residual urine volume after voiding
Pelvic ultrasound will be used to evaluate residual urine volume (ml) after voiding.
Measured: Change in residual urine volume after voiding from baseline up to end of 6th week
Physical Fitness Assessment-Thoracic Expansion Capacity
Thoracic expansion capacity (cm)
Measured: Change in parameters from baseline up to end of 6th week
Physical Fitness Assessment- Sit-Up test
Sit-Up test (number of repetitions in 30 seconds)
Measured: Change in parameters from baseline up to end of 6th week
Physical Fitness Assessment- Sit and Reach Test
Sit and Reach Test (cm)
Measured: Change in parameters from baseline up to end of 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start20 Apr 2024
- Primary completion3 Feb 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251557
- Sponsor's protocol ID
- KA-23059
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.
PubMed 25772695Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.
PubMed 15711352Morgan KE, Leroy SV, Corbett ST, Shepard JA. Complementary and Integrative Management of Pediatric Lower Urinary Tract Dysfunction Implemented within an Interprofessional Clinic. Children (Basel). 2019 Jul 30;6(8):88. doi: 10.3390/children6080088.
PubMed 31366055
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core-Based Massage and Exercise Training in Children With Lower Urinary Tract Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06251557
- Acronym / sponsor ID
- KA-23059
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Children, Biofeedback therapy, Urotherapy, core-based exercise, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lower urinary tract dysfunctions (LUTD) are common in the pediatric population and include symptoms related to functional disorders. LUTD limits children and their parents socially, physically, and financially; leads to secondary comorbidities in the long term and negatively affects quality of life. Therefore, effective treatment of LUTD is important. Treatment options in children with LUTD include standard urotherapy, physiotherapy and rehabilitation practices, pharmacologic approaches, and Botulinum toxin type A injections. Pharmacologic treatment and invasive approaches have high side effect rates and compliance problems; therefore, conservative treatment methods should be completed first. The literature focuses on standard urotherapy, pharmacologic approaches and biofeedback therapy. However, standard urotherapy and biofeedback are first-line treatments for pediatric LUTD, but their success rates are often limited. In addition, the pelvic floor contributes to abdomino-lumbopelvic stability and works in synergy with diaphragm, deep abdominal muscles and spinal segments. To the best of our knowledge, there is no study in this population that comprehensively addresses the anatomical structures closely related to the pelvic floor with a more holistic perspective beyond the standard patient education and pelvic floor. Therefore, The aim of our study is to demonstrate the additional effects of core-based massage and exercise training in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design.
Detailed description
Pediatric lower urinary tract dysfunction (LUTD) is a common and multifactorial health problem. A holistic perspective is required in treatment. Therefore, the aim of our study is to demonstrate the additional effects of massage therapy and exercise training for the abdomino-lumbopelvic area in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design. At the beginning of our study, sample size was estimated using the G Power 3.1.9.7 program. To detect a clinically significant difference of 30% between the groups (80% improvement in the research arm and 50% in the control arm) with 80% power and an alpha level of 0.05 based on a one-sided hypothesis, the minimum sample size was determined to be 42 participants, with 21 allocated to each group. The study will include 42 volunteer children aged 7-15 years with symptoms associated with functional LUTD, accompanied by their parents. Children will be randomly assigned to 2 separate groups according to an online computer generated, gender stratified block randomization list. Group 1 will receive core-based massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy. Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy. The treatments will be applied 2 days a week for 6 weeks. Children will be evaluated at the beginning of the study and at the end of the treatment (6th week). The primary outcome measure is the "Dysfunctional Voiding and Incontinence Score". Secondary outcome measures are 3-day voiding and defecation diaries data, uroflowmetry parameters, residual urine volume after voiding by pelvic ultrasound and physical fitness parameters. SPSS program will be used for data analysis. In the comparison of numerical data between 2 independent groups, "Independent Groups T Test" will be used when parametric assumptions are met and "Mann-Whitney U test" will be used when parametric assumptions are not met. In the analysis of change within the dependent group, "Significance Test of the Difference Between Two Pairs" will be used when parametric assumptions are met and "Wilcoxon Test" will be used when parametric assumptions are not met. In the examination of the change in outcome measurements over time, the effect of the treatments in both groups on the dependent variables in all evaluations (In-group factor, Time; pre-treatment and post-treatment) will be tested with "Repeated Measures of Anova" using Treatment Group*Time (2*2) factors. Type-1 error level for statistical significance will be based on 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy | Experimental | Other: Massage Therapy, Other: Exercise Training, Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy, Behavioral: Standard UrotherapyGroup 1 will receive abdomino-lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy. |
| Standard Urotherapy and Biofeedback Therapy | Active comparator | Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy, Behavioral: Standard UrotherapyGroup 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 7 and 15
- Presence of symptoms of functional lower urinary tract dysfunction
- Do not have a condition (such as autism, ADHD-Attention Deficit and Hyperactivity Disorder) that would prevent cooperation with the assessments and interventions in the study
- Consented to participate in the study by their parents
Key exclusion criteria (8 listed)
- Symptomatic urinary tract infection,
- A neurological disease,
- Neurogenic bladder/bowel diagnosis,
- Monosymptomatic enuresis,
- Anatomical anomaly that may affect bladder/bowel function,
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 |
|---|---|---|
| Massage Therapy10 minutes abdominal massage and 10 minutes lower back massage will be applied in each session. It will take 20 minutes in total. | Other | Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy |
| Exercise TrainingExercise training will last approximately 10 minutes in each session. In the exercise training, lumbopelvic stabilization exercises (bridge, cat-and-cow and squatting exercises) will be performed for 10 repetitions, lumbopelvic flexibility exercises (child position, happy baby position, adductor muscle stretching, psoas muscle stretching) will be performed for 20 seconds and 5 repetitions, and diaphragmatic breathing exercises will be performed for 5 repetitions in supine, side lying and sitting positions. | Other | Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy |
| Pelvic Floor Electromyography (EMG) Biofeedback TherapyBiofeedback therapy will be applied for 20 minutes in each session. During the application, adhesive surface electrodes will be placed on the perineum at 3 o'clock and 9 o'clock for each child. Through these electrodes, the activity signals of the muscles in that area will be recorded superficially. By monitoring the regional muscle activity, feedback is provided to increase and/or decrease the activity according to the activity pattern. As a result, pelvic floor biofeedback therapy will teach the child the correct use of the pelvic floor muscles. During the session, pelvic floor awareness and relaxation exercises specific to the child will be practiced with visual animations. | Device | Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy, Standard Urotherapy and Biofeedback Therapy |
| Standard UrotherapyThe anatomy of the urinary system and related structures, the causes of voiding dysfunction and symptoms will be explained to the family and the child with visuals. A written form including timed voiding during the day, appropriate fluid intake, correct toilet posture, adequate and balanced nutrition will be given. | Behavioural | Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy, Standard Urotherapy and Biofeedback Therapy |
Primary outcome
Symptom score
Time frame: Change in symptom score from baseline up to end of 6th week
Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire will be used to evaluate the symptom score.
8 secondary outcomes
Frequency of voiding and incontinence
Time frame: Change in frequency of voiding, incontinence and defecation from baseline up to end of 6th week
Maximum and mean voided volumes
Time frame: Change in maximum and mean voided volumes (ml) from baseline up to end of 6th week
Uroflowmeter parameters- Maximum Flow Rate
Time frame: Change in uroflowmeter parameters from baseline up to end of 6th week
Uroflowmeter parameters- Curve Type
Time frame: Change in uroflowmeter curve type from baseline up to end of 6th week
Residual urine volume after voiding
Time frame: Change in residual urine volume after voiding from baseline up to end of 6th week
Physical Fitness Assessment-Thoracic Expansion Capacity
Time frame: Change in parameters from baseline up to end of 6th week
Physical Fitness Assessment- Sit-Up test
Time frame: Change in parameters from baseline up to end of 6th week
Physical Fitness Assessment- Sit and Reach Test
Time frame: Change in parameters from baseline up to end of 6th week
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 30 Apr 2026.
- Background: PubMed 25772695Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.
- Background: PubMed 15711352Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.
- Background: PubMed 31366055Morgan KE, Leroy SV, Corbett ST, Shepard JA. Complementary and Integrative Management of Pediatric Lower Urinary Tract Dysfunction Implemented within an Interprofessional Clinic. Children (Basel). 2019 Jul 30;6(8):88. doi: 10.3390/children6080088.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy, Exercise Training and Pelvic Floor Electromyography (EMG) Biofeedback Therapy in people with Lower Urinary Tract Symptoms, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Symptom score (time frame: Change in symptom score from baseline up to end of 6th week). 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 NCT06251557, which also lists 3 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 30 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.