Overactive Bladder (OAB)NCT07206446
A Prospective Evaluation of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women: The RiSolve Trial
A study testing RiSolve in people with Overactive Bladder (OAB) and Over Active Bladder, run by University of Galway at 1 site in Ireland.
Trial summary
The RiSolve Trial is a prospective, single-arm, post-market clinical investigation designed to evaluate the effectiveness, usability, and safety of a prescription digital therapeutic (PDTx) for women suffering from overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Over Active Bladder
- What is being tested?
- RiSolve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIreland
- Study dates
- 15 Oct 2025to 17 Feb 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women aged 18 and older with bothersome OAB symptoms: (i.e. must answer YES to one of the following):
- Do you have a sudden need to rush to the toilet to urinate that is bothersome? OR
- Does urine leak before you can get to the toilet?
- Fluency and literacy in English to enable them to understand and complete treatment and required assessments
- Currently based in the Republic of Ireland
- Ownership and use of a smartphone
- Use of at least one mobile App
- Willing to forego commencing any other OAB treatments outside of RiSolve for the trial treatment period.
Who cannot join
- Current use of an anticholinergic/beta-agonist, within the previous two weeks and/or at the date of consenting
- Currently using intermittent or indwelling catheter
- Currently pregnant or planning pregnancy during the study treatment period
- Currently receiving treatment for bladder/urethral, colon/anal, or cervical cancer
- Voiding dysfunction (i.e. if Yes is an answer to any of the following):
- Do you have pain in your bladder? OR
Show all 13Show fewer
- Do you have to strain to urinate?
- Currently using sacral or tibial neuromodulation.
- Has had intradetrusor therapy
- Currently taking antibiotics/drugs for urinary tract infection
- Planning surgery for pelvic organ prolapse within the trial treatment period
- Planning to undergo pessary fitting during the study period (Note: patients with an existing pessary are eligible) within the trial treatment period
- Visual impairment such that in the opinion of the PI would impair their use of the app
Trial locations and contacts
1 site in 1 country.
About this study
The RiSolve Trial is a prospective, single-arm, post-market clinical investigation designed to evaluate the effectiveness, usability, and safety of a prescription digital therapeutic (PDTx) for women suffering from overactive bladder (OAB). The study is sponsored by the University of Galway and led by Professor Andrew W. Murphy. It is scheduled to begin in August 2025 and conclude in March 2026, and will be conducted through the Primary Care Clinical Trials Network at the University of Galway. Sixty adult women based in the Republic of Ireland will be recruited to take part. Eligible participants must be at least eighteen years old, fluent in English, own a smartphone, and report bothersome OAB or urgency incontinence symptoms. Women who are pregnant, receiving certain bladder-related treatments, or using specific medications or devices will be excluded.
Overactive bladder is a chronic condition defined by urgency, urinary frequency, nocturia, and often urgency incontinence. It is highly prevalent among women and significantly impacts quality of life, with effects ranging from sleep disruption to reduced occupational performance and heightened risks of anxiety and depression. Standard treatment guidelines recommend a tiered approach, beginning with behavioural therapy, followed by pharmacological options, and finally invasive procedures such as Botox injections or neuromodulation. Behavioural therapy, although considered the gold standard, is often difficult for patients to access due to limited provider availability, cost, and stigma. RiSolve was developed to overcome these barriers by offering a comprehensive, digital, prescription-only therapeutic program.
Read more
The investigational device, the RiSolve App (REF: PDTxA001), is a CE-marked Class I medical device developed in accordance with the EU Medical Device Regulation (MDR 2017/745). It delivers an eight-week structured program combining behavioural therapy with a novel digital cognitive behavioural therapy component. Content includes bladder training, pelvic floor exercises, urge suppression strategies, education on bladder health and diet, and general wellbeing modules covering sleep, stress, and exercise. The app also provides interactive tools such as quizzes, bladder diaries, and personalised feedback. Patients complete clinically validated questionnaires and receive auto-generated progress reports, which are also shared with healthcare providers. In its design, RiSolve builds on earlier pilot work with a prior app developed at the University of Galway, which demonstrated improvements in OAB symptoms and quality of life.
The primary aim of the study is to assess usability of the RiSolve App, measured using the user version of the Mobile Application Rating Scale (uMARS). Secondary objectives include evaluating symptom improvement using the Overactive Bladder Questionnaire short-form Symptom Severity scale (OAB-q SF SS) and assessing quality of life changes with the OAB-q SF HQoL scale. Safety outcomes will focus on identifying any device-related serious adverse events.
- Conditions
- Overactive Bladder (OAB), Over Active Bladder
- Being tested
- RiSolve
- Keywords
- Over active bladder, urogynaecology, prescription digital therapeutic, pdtx, app, mobile app, decentralized, decentralised
- Medical subject headings
- Urinary Bladder, Overactive, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiSolveDevice
RiSolve is a Class I device in accordance with Rule 11 of Annex VIII of EU Medical Device Regulation (MDR) 2017/745. The RiSolve App is a smartphone application that users can download following a diagnosis of OAB by a healthcare provider, and following prescription of the RiSolve App. RiSolve consists of an 8-week program including activities to set baselines and assess progress, treatment modules, and modules to enhance engagement.
As part of setting baselines and assessing progress, participants complete a series of clinically validated questionnaires. This data is presented to users to promote self-monitoring of behaviours and a deeper understanding of their symptoms. A patient report is auto-generated at the end of treatment. This is sent to the patient and contains their in-app self-generated data, their questionnaire results and their bladder diary data (see Appendix 1: RiSolve Patient Report). This information is also provided to the prescribing healthcare provider as an object
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All participants meeting criteria for inclusion and not exclusion will be given access to the app Receives: Device: RiSolve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Usability as measured by the User version of the Mobile Application Rating Scale (uMARS)
Measured: From enrollment to the end of treatment at 8-10 weeks
Secondary outcomes (2)
Improvement in symptoms
Improvement in symptoms, as measured on the Overactive Bladder Questionnaire-Short Form, Symptom Severity (OABq-SF SS) scale
Measured: From enrollment to the end of treatment at 8-10 weeks
Improvement in quality of life
Improvement in quality of life, as measured by the Overactive Bladder Questionnaire-Short Form, health-related quality of life scale (OABq-SF HQoL)
Measured: From enrollment to the end of treatment at 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start15 Oct 2025
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Galway
- Sponsor type
- University, hospital or other
- Collaborators
- Enterprise Ireland
- Responsible party
- Principal investigator, Andrew Murphy, University of Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206446
- Sponsor's protocol ID
- UNI-2023-007
- Other IDs
- CIV-25-08-054117
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Proprietary data, sharing would give up competitive advantage
Publications
Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
PubMed 27287964Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
PubMed 16021067Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.
PubMed 23810110Dennerstein L, Lehert P, Dudley E. Short scale to measure female sexuality: adapted from McCoy Female Sexuality Questionnaire. J Sex Marital Ther. 2001 Jul-Sep;27(4):339-51. doi: 10.1080/009262301317081098.
PubMed 11441518Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. Determining the importance of change in the overactive bladder questionnaire. J Urol. 2006 Aug;176(2):627-32; discussion 632. doi: 10.1016/j.juro.2006.03.088.
PubMed 16813906Coyne KS, Matza LS, Thompson CL. The responsiveness of the Overactive Bladder Questionnaire (OAB-q). Qual Life Res. 2005 Apr;14(3):849-55. doi: 10.1007/s11136-004-0706-1.
PubMed 16022077Coyne KS, Thompson CL, Lai JS, Sexton CC. An overactive bladder symptom and health-related quality of life short-form: validation of the OAB-q SF. Neurourol Urodyn. 2015 Mar;34(3):255-63. doi: 10.1002/nau.22559. Epub 2014 Jan 13.
PubMed 25783168Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol. 2004 Jul;191(1):73-82. doi: 10.1016/j.ajog.2003.12.027.
PubMed 15295345Sanderson DJ, Zavez A, Meekins AR, Eddib A, Lee TG, Barber MD, Duecy E. The Patient Acceptable Symptom State in Female Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):33-39. doi: 10.1097/SPV.0000000000001055.
PubMed 34009829Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
PubMed 12861145Bradley CS, Rovner ES, Morgan MA, Berlin M, Novi JM, Shea JA, Arya LA. A new questionnaire for urinary incontinence diagnosis in women: development and testing. Am J Obstet Gynecol. 2005 Jan;192(1):66-73. doi: 10.1016/j.ajog.2004.07.037.
PubMed 15672005Sooknarine C, Farrell S, Sarma S, Salameh F, Burke N, Staunton B, Carr E, Sexton K, Agnew G, Downey A, D'Arcy F, Cundiff GW. Pilot Study of a Digital Behavioral Therapy for Overactive Bladder in Women. Urogynecology (Phila). 2024 Dec 1;30(12):956-961. doi: 10.1097/SPV.0000000000001499. Epub 2024 May 7.
PubMed 38465995Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD001027. doi: 10.1002/14651858.CD001027.pub2.
PubMed 18646067Etzelmueller A, Vis C, Karyotaki E, Baumeister H, Titov N, Berking M, Cuijpers P, Riper H, Ebert DD. Effects of Internet-Based Cognitive Behavioral Therapy in Routine Care for Adults in Treatment for Depression and Anxiety: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Aug 31;22(8):e18100. doi: 10.2196/18100.
PubMed 32865497Melotti IGR, Juliato CRT, Coelho SCA, Lima M, Riccetto CLZ. Is There Any Difference Between Depression and Anxiety in Overactive Bladder According to Sex? A Systematic Review and Meta-Analysis. Int Neurourol J. 2017 Sep;21(3):204-211. doi: 10.5213/inj.1734890.445. Epub 2017 Sep 12.
PubMed 28954462
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women: The RiSolve Trial
- ClinicalTrials.gov ID
- NCT07206446
- Acronym / sponsor ID
- UNI-2023-007
- Conditions
- Overactive Bladder (OAB), Over Active Bladder
- Keywords
- Over active bladder, urogynaecology, prescription digital therapeutic, pdtx, app, mobile app, decentralized, decentralised
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of GalwayUniversity, hospital or other
- Collaborators
- Enterprise Ireland
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 3 Oct 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.
The RiSolve Trial is a prospective, single-arm, post-market clinical investigation designed to evaluate the effectiveness, usability, and safety of a prescription digital therapeutic (PDTx) for women suffering from overactive bladder (OAB). The study is sponsored by the University of Galway and led by Professor Andrew W. Murphy. It is scheduled to begin in August 2025 and conclude in March 2026, and will be conducted through the Primary Care Clinical Trials Network at the University of Galway. Sixty adult women based in the Republic of Ireland will be recruited to take part. Eligible participants must be at least eighteen years old, fluent in English, own a smartphone, and report bothersome OAB or urgency incontinence symptoms. Women who are pregnant, receiving certain bladder-related treatments, or using specific medications or devices will be excluded.
Overactive bladder is a chronic condition defined by urgency, urinary frequency, nocturia, and often urgency incontinence. It is highly prevalent among women and significantly impacts quality of life, with effects ranging from sleep disruption to reduced occupational performance and heightened risks of anxiety and depression. Standard treatment guidelines recommend a tiered approach, beginning with behavioural therapy, followed by pharmacological options, and finally invasive procedures such as Botox injections or neuromodulation. Behavioural therapy, although considered the gold standard, is often difficult for patients to access due to limited provider availability, cost, and stigma. RiSolve was developed to overcome these barriers by offering a comprehensive, digital, prescription-only therapeutic program.
The investigational device, the RiSolve App (REF: PDTxA001), is a CE-marked Class I medical device developed in accordance with the EU Medical Device Regulation (MDR 2017/745). It delivers an eight-week structured program combining behavioural therapy with a novel digital cognitive behavioural therapy component. Content includes bladder training, pelvic floor exercises, urge suppression strategies, education on bladder health and diet, and general wellbeing modules covering sleep, stress, and exercise. The app also provides interactive tools such as quizzes, bladder diaries, and personalised feedback. Patients complete clinically validated questionnaires and receive auto-generated progress reports, which are also shared with healthcare providers. In its design, RiSolve builds on earlier pilot work with a prior app developed at the University of Galway, which demonstrated improvements in OAB symptoms and quality of life.
The primary aim of the study is to assess usability of the RiSolve App, measured using the user version of the Mobile Application Rating Scale (uMARS). Secondary objectives include evaluating symptom improvement using the Overactive Bladder Questionnaire short-form Symptom Severity scale (OAB-q SF SS) and assessing quality of life changes with the OAB-q SF HQoL scale. Safety outcomes will focus on identifying any device-related serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: RiSolveAll participants meeting criteria for inclusion and not exclusion will be given access to the app |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult women aged 18 and older with bothersome OAB symptoms: (i.e. must answer YES to one of the following):
- Fluency and literacy in English to enable them to understand and complete treatment and required assessments
- Currently based in the Republic of Ireland
- Ownership and use of a smartphone
- Use of at least one mobile App
Key exclusion criteria (13 listed)
- Current use of an anticholinergic/beta-agonist, within the previous two weeks and/or at the date of consenting
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 |
|---|---|---|
| RiSolveRiSolve is a Class I device in accordance with Rule 11 of Annex VIII of EU Medical Device Regulation (MDR) 2017/745. The RiSolve App is a smartphone application that users can download following a diagnosis of OAB by a healthcare provider, and following prescription of the RiSolve App. RiSolve consists of an 8-week program including activities to set baselines and assess progress, treatment modules, and modules to enhance engagement. As part of setting baselines and assessing progress, participants complete a series of clinically validated questionnaires. This data is presented to users to promote self-monitoring of behaviours and a deeper understanding of their symptoms. A patient report is auto-generated at the end of treatment. This is sent to the patient and contains their in-app self-generated data, their questionnaire results and their bladder diary data (see Appendix 1: RiSolve Patient Report). This information is also provided to the prescribing healthcare provider as an object | Device | Single Arm |
Primary outcome
Usability
Time frame: From enrollment to the end of treatment at 8-10 weeks
Usability as measured by the User version of the Mobile Application Rating Scale (uMARS)
2 secondary outcomes
Improvement in symptoms
Time frame: From enrollment to the end of treatment at 8-10 weeks
Improvement in quality of life
Time frame: From enrollment to the end of treatment at 8-10 weeks
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 11 Jun 2026.
- Background: PubMed 27287964Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
- Background: PubMed 16021067Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Background: PubMed 23810110Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.
- Background: PubMed 11441518Dennerstein L, Lehert P, Dudley E. Short scale to measure female sexuality: adapted from McCoy Female Sexuality Questionnaire. J Sex Marital Ther. 2001 Jul-Sep;27(4):339-51. doi: 10.1080/009262301317081098.
- Background: PubMed 16813906Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. Determining the importance of change in the overactive bladder questionnaire. J Urol. 2006 Aug;176(2):627-32; discussion 632. doi: 10.1016/j.juro.2006.03.088.
- Background: PubMed 16022077Coyne KS, Matza LS, Thompson CL. The responsiveness of the Overactive Bladder Questionnaire (OAB-q). Qual Life Res. 2005 Apr;14(3):849-55. doi: 10.1007/s11136-004-0706-1.
- Background: PubMed 25783168Coyne KS, Thompson CL, Lai JS, Sexton CC. An overactive bladder symptom and health-related quality of life short-form: validation of the OAB-q SF. Neurourol Urodyn. 2015 Mar;34(3):255-63. doi: 10.1002/nau.22559. Epub 2014 Jan 13.
- Background: PubMed 15295345Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol. 2004 Jul;191(1):73-82. doi: 10.1016/j.ajog.2003.12.027.
- Background: PubMed 34009829Sanderson DJ, Zavez A, Meekins AR, Eddib A, Lee TG, Barber MD, Duecy E. The Patient Acceptable Symptom State in Female Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):33-39. doi: 10.1097/SPV.0000000000001055.
- Background: PubMed 12861145Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
- Background: PubMed 15672005Bradley CS, Rovner ES, Morgan MA, Berlin M, Novi JM, Shea JA, Arya LA. A new questionnaire for urinary incontinence diagnosis in women: development and testing. Am J Obstet Gynecol. 2005 Jan;192(1):66-73. doi: 10.1016/j.ajog.2004.07.037.
- Background: PubMed 38465995Sooknarine C, Farrell S, Sarma S, Salameh F, Burke N, Staunton B, Carr E, Sexton K, Agnew G, Downey A, D'Arcy F, Cundiff GW. Pilot Study of a Digital Behavioral Therapy for Overactive Bladder in Women. Urogynecology (Phila). 2024 Dec 1;30(12):956-961. doi: 10.1097/SPV.0000000000001499. Epub 2024 May 7.
- Study webpage featuring downloadable Participant Information LeafletLink provided by the sponsor.
- Individual participant dataSharing planned: No. Proprietary data, sharing would give up competitive advantage
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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 RiSolve in people with Overactive Bladder (OAB) and Over Active Bladder, run by University of Galway at 1 site in Ireland.
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 13 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 11 Jun 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 Ireland. 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?
Usability (time frame: From enrollment to the end of treatment at 8-10 weeks). 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 NCT07206446, which also lists 35 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 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.