A new clinical trial has been unveiled to test RiSolve, a prescription digital therapeutic, focusing on the treatment of overactive bladder (OAB) in women. Sponsored by the University of Galway and Enterprise Ireland, this research represents a novel intersection of medical devices and digital health solutions aimed at addressing a common yet challenging condition.
The trial is listed as “Not yet recruiting,” signaling upcoming opportunities for interested participants and stakeholders. Clinical teams, regulatory experts, and quality management professionals will closely monitor this study as it develops.
In this article
- What changed?
- Trial details and scope
- Medical device compliance considerations
- FAQ
- Conclusion
- Disclaimer
- Announcement link
What changed?
This announcement reveals plans for the RiSolve Trial, a prospective evaluation of a prescription digital therapeutic tailored for OAB in women. RiSolve aims to leverage advancements in digital health technology to provide innovative, evidence-driven solutions within a structured clinical framework.
The trial addresses a regulatory opportunity to assess and validate digital therapeutics under controlled conditions, which may inform future medical device policy, reimbursement pathways, and clinical integration.
Trial details and scope
Overactive bladder is a complex urinary disorder characterized by urinary urgency, frequency, and potentially incontinence. It significantly impacts quality of life, particularly among women. RiSolve introduces a device-based approach rather than traditional pharmaceutical solutions.
Key sponsors
The University of Galway and Enterprise Ireland are co-sponsoring the trial. This academic-industry collaboration underscores the alignment of regulatory, research, and commercial interests in advancing therapeutic devices.
Recruitment timeline
As of the announcement date, the trial is marked “Not yet recruiting.” Recruitment phases, inclusion criteria, and participant instructions will likely emerge in updates once trial protocols are finalized.
Innovative therapeutic approach
RiSolve exemplifies prescription digital therapeutics harnessing software-enabled interventions. As a device, it intends to deliver tailored therapy, supported by data collection and behavioral analytics, to manage OAB symptoms.
Medical device compliance considerations
Digital therapeutics like RiSolve must adhere to stringent regulatory frameworks such as the Medical Device Regulation (MDR) in Europe and FDA guidelines in the US. Compliance will involve risk management, clinical evaluation, performance validation, and post-market surveillance.
The trial will offer valuable insights into the process by which digital therapeutic devices can meet these requirements while maintaining user safety, effectiveness, and accessibility.
Global impact potential
The acceptance of digital therapeutics for OAB could extend globally, influencing standards across healthcare systems, including interoperability of software devices and data security.
FAQ
1. What is RiSolve?
RiSolve is a prescription digital therapeutic designed to address overactive bladder symptoms in women using device-based interventions.
2. When will the trial start recruiting?
The trial is currently listed as “Not yet recruiting.” Specific dates are unavailable, but updates are expected as plans progress.
3. Who are the sponsors?
The University of Galway and Enterprise Ireland are co-sponsoring the RiSolve Trial.
4. How can professionals stay informed?
ClinicalTrials.gov and academic publications from the sponsors will likely provide further details as the study progresses.
Conclusion
The RiSolve Trial signifies a critical advancement in digital therapeutics for managing overactive bladder. Quality and regulatory teams should see this as a case study illustrating modern compliance challenges regarding digital health innovations.
Interdisciplinary collaboration will be necessary to maximize the trial’s impact, setting benchmarks for future device validation while improving women’s health outcomes.
Disclaimer
The content provided is for informational purposes targeted at professionals. It does not constitute legal advice. Readers are advised to consult regulatory guidelines directly.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07206446?term=medical+device