Urinary IncontinenceSE-inc1NCT06933407
Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women
An observational study of Urinary Incontinence and Urinary Incontinence, Stress, run by Szeged University at 1 site in Hungary.
Trial summary
Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence (UI)
- What is being tested?
- Strain Elastography
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- 16 Aug 2024to 1 Jan 2030
- Phase
- Observational
- 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include adult women in Hungary diagnosed with stress urinary incontinence (SUI), along with a control group of continent women. Participants will be recruited from urogynecology outpatient clinics, tertiary referral centers, and gynecology departments.
Who may be able to join
- Clinical diagnosis of stress urinary incontinence (SUI) based on patient history, physical examination, and/or urodynamic assessment.
Who cannot join
- Pelvic malignancy or history of pelvic radiation therapy
- Urge urinary incontinence (UUI) or detrusor overactivity
- Pelvic organ prolapse (POP) stage ≥ II (based on POP-Q classification)
- Pregnancy or recent postpartum status (less than 6 months postpartum)
- Neurological disorders affecting bladder function
- Recurrent urinary tract infections (UTIs) or active lower urinary tract infection
- Inability to undergo study procedures
- Cognitive impairment or psychiatric conditions affecting informed consent or compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: This Study Investigates the Role of Strain Elastography in Assessing Paraurethral Tissue Elasticity in Continent and Incontinent Pre- and Postmenopausal Women. It Also Evaluates the Predictive Value of Strain Elastography Compared to Other Pelvic Imaging Modalities, Including Conventional Ultrasound Examinations, in Supporting Treatment Decision-making for Urinary Incontinence.
Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. The primary aim is to determine whether SE can detect differences in paraurethral tissue stiffness between these groups. Given the established role of tissue elasticity in the pathophysiology of SUI, SE will be investigated as a potential diagnostic tool in urogynecological evaluations.
This prospective cohort study will be conducted at a tertiary referral center. All participants will undergo introital two-dimensional (2D) ultrasound in the midsagittal plane at rest. SE will be performed in three predefined suburethral regions of interest (ROIs):
Read more
- internal urethral orifice (IUO) level
- midurethra (MU) level
- external urethral orifice (EUO) level
The adipose layer (AL) between the external urethral meatus and the pubic symphysis will serve as the reference tissue, representing the softest anatomical structure in the region.
Descriptive and comparative statistical analyses will be conducted to assess differences in paraurethral tissue stiffness between the study groups.
It is hypothesized that SE will be able to detect differences in paraurethral tissue elasticity, with SUI being associated with increased tissue compliance. The study also aims to determine whether SE can reliably distinguish between varying degrees of tissue stiffness in women with SUI and continent controls.
Pathophysiological focus:
The study will explore key mechanisms underlying SUI, including:
- Weakened bladder neck support
- Impaired urethral stabilization due to increased tissue elasticity and collagen degradation
- While conventional 2D ultrasound provides anatomical information, it does not directly evaluate tissue biomechanics. In contrast, SE enables real-time visualization of tissue elasticity, offering a promising adjunct to traditional urogynecological assessment methods.
Standardization and Protocol
The study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include:
- Minimal probe compression during introital ultrasound to avoid artifacts
- Bladder emptying prior to examination to eliminate confounding effects
- Carefully standardized ROI placement across all patients
- Controlled image acquisition conditions to reduce variability
Future Directions
- Future research based on this study will aim to:
- Optimize SE protocols and refine ROI placement strategies
- Establish clinical cutoff values for differentiating tissue stiffness in SUI vs. continent women
- Assess the long-term effects of pelvic floor muscle training (PFMT) and vaginal estrogen therapy on paraurethral biomechanics
- Facilitate the integration of SE into routine urogynecological practice to support early diagnosis and personalized treatment strategies for SUI
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence (UI), Urinary Bladder, Overactive, Incontinence, Overactive Bladder, Stress Urinary Incontinence, Stress Urinary Incontinence (SUI)
- Being tested
- Strain Elastography
- Keywords
- Urinary Incontinence, Bladder dysfunction, Urine leakage, Stress urinary incontinence (SUI)
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain ElastographyDiagnostic test
Strain elastography (SE) is a parametric imaging modality that assesses tissue deformation in response to externally applied pressure, providing qualitative and semi-quantitative information on tissue elasticity and mechanical properties. Unlike conventional 2D ultrasound, SE enables the objective evaluation of paraurethral tissue stiffness, which may play a role in the pathophysiology of stress urinary incontinence (SUI). SE will be performed on three predefined paraurethral regions to assess pelvic floor elasticity and biomechanical characteristics. A standardized protocol will be implemented to ensure high reproducibility, with controlled probe compression and precisely defined regions of interest. SE may improve the diagnostic accuracy and therapeutic decision-making for SUI by identifying differences in tissue compliance among affected women.
| Study group | Role | What they receive |
|---|---|---|
| Control group (asymptomatic women) | This group consists of women without any symptoms of urinary incontinence. They serve as a baseline for comparison with the affected groups. No specific intervention is applied to this group. Receives: Diagnostic Test: Strain Elastography | |
| Stress urinary incontinence (SUI) group | This group includes women diagnosed with stress urinary incontinence (SUI), characterized by involuntary urine leakage during physical exertion, coughing, sneezing, or other activities that increase intra-abdominal pressure. Receives: Diagnostic Test: Strain Elastography | |
| Stress urinary incontinence (SUI) with hypermobile urethra | This subgroup includes women with stress urinary incontinence and hypermobility of the urethra, which is assessed through clinical examination and/or imaging techniques. Receives: Diagnostic Test: Strain Elastography | |
| Stress urinary incontinence (SUI) without hypermobile urethra | This subgroup consists of women with stress urinary incontinence but without significant urethral hypermobility. The absence of hypermobility may suggest intrinsic sphincter deficiency (ISD) as a primary factor in incontinence. Receives: Diagnostic Test: Strain Elastography | |
| Stress urinary incontinence (SUI) group without estrogen therapy | Women diagnosed with stress urinary incontinence (SUI) who do not receive vaginal estrogen therapy. This group will serve as a reference to assess the natural biomechanical properties of paraurethral tissues in SUI patients. Receives: Diagnostic Test: Strain Elastography | |
| Stress urinary incontinence (SUI) group with estrogen therapy | Women diagnosed with stress urinary incontinence (SUI) who undergo vaginal estrogen therapy as part of their treatment. This group will be evaluated to determine the effects of vaginal estrogen on paraurethral tissue elasticity and its potential role in improving urethral support and biomechanical properties. Receives: Diagnostic Test: Strain Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Paraurethral Tissue Elasticity in Women with Stress Urinary Incontinence Using Strain Elastography
Detection of a statistically significant difference in paraurethral tissue elasticity between women with stress urinary incontinence (SUI) and continent controls using strain elastography (SE), with high measurement reproducibility across predefined regions of interest.
Measured: At a single study visit, within two weeks of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start16 Aug 2024
- Primary completion30 Mar 2025
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Collaborators
- Capio Specialized Center for Gynecology, Solna, 182 88 Stockholm, Sweden
- Responsible party
- Principal investigator, Dr. Csákány Lóránt, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933407
- Sponsor's protocol ID
- 55/2016
- Acronym
- SE-inc1
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Quantitative strain elastography measurements of periurethral tissue elasticity.
Publications
Falconer C, Ekman-Ordeberg G, Ulmsten U, Westergren-Thorsson G, Barchan K, Malmstrom A. Changes in paraurethral connective tissue at menopause are counteracted by estrogen. Maturitas. 1996 Jul;24(3):197-204. doi: 10.1016/s0378-5122(96)82010-x.
PubMed 8844634Tunn R, Petri E. Introital and transvaginal ultrasound as the main tool in the assessment of urogenital and pelvic floor dysfunction: an imaging panel and practical approach. Ultrasound Obstet Gynecol. 2003 Aug;22(2):205-13. doi: 10.1002/uog.189.
PubMed 12905521DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
PubMed 8203431Kreutzkamp JM, Schafer SD, Amler S, Strube F, Kiesel L, Schmitz R. Strain Elastography as a New Method for Assessing Pelvic Floor Biomechanics. Ultrasound Med Biol. 2017 Apr;43(4):868-872. doi: 10.1016/j.ultrasmedbio.2016.12.004. Epub 2017 Jan 17.
PubMed 28108041Zhao B, Wen L, Chen W, Qing Z, Liu D, Liu M. A Preliminary Study on Quantitative Quality Measurements of the Urethral Rhabdosphincter Muscle by Supersonic Shear Wave Imaging in Women With Stress Urinary Incontinence. J Ultrasound Med. 2020 Aug;39(8):1615-1621. doi: 10.1002/jum.15255. Epub 2020 Mar 3.
PubMed 32125001Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
PubMed 33416968Patel UJ, Godecker AL, Giles DL, Brown HW. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):181-187. doi: 10.1097/SPV.0000000000001127. Epub 2022 Jan 12.
PubMed 35030139
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study Investigates the Role of Strain Elastography in Assessing Paraurethral Tissue Elasticity in Continent and Incontinent Pre- and Postmenopausal Women. It Also Evaluates the Predictive Value of Strain Elastography Compared to Other Pelvic Imaging Modalities, Including Conventional Ultrasound Examinations, in Supporting Treatment Decision-making for Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT06933407
- Acronym / sponsor ID
- SE-inc1 / 55/2016
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence (UI), Urinary Bladder, Overactive, Incontinence, Overactive Bladder, Stress Urinary Incontinence, Stress Urinary Incontinence (SUI)
- Keywords
- Urinary Incontinence, Bladder dysfunction, Urine leakage, Stress urinary incontinence (SUI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Collaborators
- Capio Specialized Center for Gynecology, Solna, 182 88 Stockholm, Sweden
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 18 Apr 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.
Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. The primary aim is to determine whether SE can detect differences in paraurethral tissue stiffness between these groups. Given the established role of tissue elasticity in the pathophysiology of SUI, SE will be investigated as a potential diagnostic tool in urogynecological evaluations.
This prospective cohort study will be conducted at a tertiary referral center. All participants will undergo introital two-dimensional (2D) ultrasound in the midsagittal plane at rest. SE will be performed in three predefined suburethral regions of interest (ROIs):
- internal urethral orifice (IUO) level
- midurethra (MU) level
- external urethral orifice (EUO) level
The adipose layer (AL) between the external urethral meatus and the pubic symphysis will serve as the reference tissue, representing the softest anatomical structure in the region.
Descriptive and comparative statistical analyses will be conducted to assess differences in paraurethral tissue stiffness between the study groups.
It is hypothesized that SE will be able to detect differences in paraurethral tissue elasticity, with SUI being associated with increased tissue compliance. The study also aims to determine whether SE can reliably distinguish between varying degrees of tissue stiffness in women with SUI and continent controls.
Pathophysiological focus:
The study will explore key mechanisms underlying SUI, including:
- Weakened bladder neck support
- Impaired urethral stabilization due to increased tissue elasticity and collagen degradation
- While conventional 2D ultrasound provides anatomical information, it does not directly evaluate tissue biomechanics. In contrast, SE enables real-time visualization of tissue elasticity, offering a promising adjunct to traditional urogynecological assessment methods.
Standardization and Protocol
The study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include:
- Minimal probe compression during introital ultrasound to avoid artifacts
- Bladder emptying prior to examination to eliminate confounding effects
- Carefully standardized ROI placement across all patients
- Controlled image acquisition conditions to reduce variability
Future Directions
- Future research based on this study will aim to:
- Optimize SE protocols and refine ROI placement strategies
- Establish clinical cutoff values for differentiating tissue stiffness in SUI vs. continent women
- Assess the long-term effects of pelvic floor muscle training (PFMT) and vaginal estrogen therapy on paraurethral biomechanics
- Facilitate the integration of SE into routine urogynecological practice to support early diagnosis and personalized treatment strategies for SUI
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control group (asymptomatic women) | – | Diagnostic Test: Strain ElastographyThis group consists of women without any symptoms of urinary incontinence. They serve as a baseline for comparison with the affected groups. No specific intervention is applied to this group. |
| Stress urinary incontinence (SUI) group | – | Diagnostic Test: Strain ElastographyThis group includes women diagnosed with stress urinary incontinence (SUI), characterized by involuntary urine leakage during physical exertion, coughing, sneezing, or other activities that increase intra-abdominal pressure. |
| Stress urinary incontinence (SUI) with hypermobile urethra | – | Diagnostic Test: Strain ElastographyThis subgroup includes women with stress urinary incontinence and hypermobility of the urethra, which is assessed through clinical examination and/or imaging techniques. |
| Stress urinary incontinence (SUI) without hypermobile urethra | – | Diagnostic Test: Strain ElastographyThis subgroup consists of women with stress urinary incontinence but without significant urethral hypermobility. The absence of hypermobility may suggest intrinsic sphincter deficiency (ISD) as a primary factor in incontinence. |
| Stress urinary incontinence (SUI) group without estrogen therapy | – | Diagnostic Test: Strain ElastographyWomen diagnosed with stress urinary incontinence (SUI) who do not receive vaginal estrogen therapy. This group will serve as a reference to assess the natural biomechanical properties of paraurethral tissues in SUI patients. |
| Stress urinary incontinence (SUI) group with estrogen therapy | – | Diagnostic Test: Strain ElastographyWomen diagnosed with stress urinary incontinence (SUI) who undergo vaginal estrogen therapy as part of their treatment. This group will be evaluated to determine the effects of vaginal estrogen on paraurethral tissue elasticity and its potential role in improving urethral support and biomechanical properties. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult women in Hungary diagnosed with stress urinary incontinence (SUI), along with a control group of continent women. Participants will be recruited from urogynecology outpatient clinics, tertiary referral centers, and gynecology departments.
Key inclusion criteria (1 listed)
- Clinical diagnosis of stress urinary incontinence (SUI) based on patient history, physical examination, and/or urodynamic assessment.
Key exclusion criteria (8 listed)
- Pelvic malignancy or history of pelvic radiation therapy
- Urge urinary incontinence (UUI) or detrusor overactivity
- Pelvic organ prolapse (POP) stage ≥ II (based on POP-Q classification)
- Pregnancy or recent postpartum status (less than 6 months postpartum)
- Neurological disorders affecting bladder 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 |
|---|---|---|
| Strain ElastographyStrain elastography (SE) is a parametric imaging modality that assesses tissue deformation in response to externally applied pressure, providing qualitative and semi-quantitative information on tissue elasticity and mechanical properties. Unlike conventional 2D ultrasound, SE enables the objective evaluation of paraurethral tissue stiffness, which may play a role in the pathophysiology of stress urinary incontinence (SUI). SE will be performed on three predefined paraurethral regions to assess pelvic floor elasticity and biomechanical characteristics. A standardized protocol will be implemented to ensure high reproducibility, with controlled probe compression and precisely defined regions of interest. SE may improve the diagnostic accuracy and therapeutic decision-making for SUI by identifying differences in tissue compliance among affected women. | Diagnostic test | Control group (asymptomatic women), Stress urinary incontinence (SUI) group, Stress urinary incontinence (SUI) group with estrogen therapy, Stress urinary incontinence (SUI) group without estrogen therapy, Stress urinary incontinence (SUI) with hypermobile urethra, Stress urinary incontinence (SUI) without hypermobile urethra |
Primary outcome
Assessment of Paraurethral Tissue Elasticity in Women with Stress Urinary Incontinence Using Strain Elastography
Time frame: At a single study visit, within two weeks of enrollment.
Detection of a statistically significant difference in paraurethral tissue elasticity between women with stress urinary incontinence (SUI) and continent controls using strain elastography (SE), with high measurement reproducibility across predefined regions of interest.
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 Apr 2025.
- Results publication: PubMed 8844634Falconer C, Ekman-Ordeberg G, Ulmsten U, Westergren-Thorsson G, Barchan K, Malmstrom A. Changes in paraurethral connective tissue at menopause are counteracted by estrogen. Maturitas. 1996 Jul;24(3):197-204. doi: 10.1016/s0378-5122(96)82010-x.
- Results publication: PubMed 12905521Tunn R, Petri E. Introital and transvaginal ultrasound as the main tool in the assessment of urogenital and pelvic floor dysfunction: an imaging panel and practical approach. Ultrasound Obstet Gynecol. 2003 Aug;22(2):205-13. doi: 10.1002/uog.189.
- Results publication: PubMed 8203431DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
- Results publication: PubMed 28108041Kreutzkamp JM, Schafer SD, Amler S, Strube F, Kiesel L, Schmitz R. Strain Elastography as a New Method for Assessing Pelvic Floor Biomechanics. Ultrasound Med Biol. 2017 Apr;43(4):868-872. doi: 10.1016/j.ultrasmedbio.2016.12.004. Epub 2017 Jan 17.
- Results publication: PubMed 32125001Zhao B, Wen L, Chen W, Qing Z, Liu D, Liu M. A Preliminary Study on Quantitative Quality Measurements of the Urethral Rhabdosphincter Muscle by Supersonic Shear Wave Imaging in Women With Stress Urinary Incontinence. J Ultrasound Med. 2020 Aug;39(8):1615-1621. doi: 10.1002/jum.15255. Epub 2020 Mar 3.
- Results publication: PubMed 33416968Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
- Results publication: PubMed 35030139Patel UJ, Godecker AL, Giles DL, Brown HW. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):181-187. doi: 10.1097/SPV.0000000000001127. Epub 2022 Jan 12.
- Individual participant dataSharing planned: Yes. Quantitative strain elastography measurements of periurethral tissue elasticity.
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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?
An observational study of Urinary Incontinence and Urinary Incontinence, Stress, run by Szeged University at 1 site in Hungary.
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 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: looking for participants now, as of the sponsor's last update on 18 Apr 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 Hungary. 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 Lóránt Csákány, Dr. (+36305895619, md.csakany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Paraurethral Tissue Elasticity in Women with Stress Urinary Incontinence Using Strain Elastography (time frame: At a single study visit, within two weeks of enrollment.). 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 NCT06933407, 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 18 Apr 2025.