On October 7, 2025, a groundbreaking clinical trial was registered to evaluate the safety and efficacy of detrusor nerve radiofrequency ablation (DNRA) for treating overactive bladder (OAB) and related conditions in women. Sponsored by InMode MD Ltd. in collaboration with the Foundation for Female Health Awareness, the trial marks an important step in exploring novel therapeutic devices designed to address urinary disorders. Although the study is not yet recruiting, its launch provides clarity for clinical, regulatory, and quality teams in the medical device field.
What is Overactive Bladder?
Overactive bladder (OAB) is a condition characterized by urinary urgency, frequent urination, and in some cases, urge urinary incontinence. It can significantly impact a person’s quality of life, leading to physical discomfort and psychological distress.
The trial will also focus on mixed urinary incontinence, with emphasis on urge-predominant cases, as well as idiopathic OAB with urinary incontinence. These subgroups represent complex manifestations of bladder dysfunction requiring novel approaches.
What is Detrusor Nerve Radiofrequency Ablation?
Detrusor nerve radiofrequency ablation (DNRA) is a minimally invasive procedure designed to modulate nervous control of bladder function. By targeting specific nerves within the detrusor muscle, DNRA aims to reduce overactive signaling, thereby improving symptoms of OAB and related disorders.
The trial will evaluate two interventions: (1) DNRA using active treatment devices and (2) a sham procedure that simulates DNRA without delivering therapeutic effects. This design helps differentiate true therapeutic impact from placebo responses.
Clinical Trial Details
The randomized controlled trial will be sponsored by InMode MD Ltd., a medical device manufacturer, alongside the Foundation for Female Health Awareness.
According to the registration entry, the study remains in its pre-recruitment phase. Steps toward compliance with medical device regulations, informed consent procedures, and protocol standardization are key preparatory milestones. Once recruitment begins, the trial will likely engage participants across multiple centers to ensure statistical reliability.
The device involved is subjected to rigorous performance and safety evaluations throughout the trial, aligned with MDR Annex XIV principles. Quality assurance teams should monitor upcoming updates on its outcomes.
Frequently Asked Questions
1. Who can participate in this clinical trial?
Eligibility criteria have not yet been released, but the target population includes women with OAB or related conditions.
2. When will recruitment begin?
The trial is currently listed as not yet recruiting. Interested parties can monitor updates on ClinicalTrials.gov.
Conclusion
The upcoming trial on DNRA devices is poised to advance clinical understanding and therapeutic options for overactive bladder. Stakeholders, including regulatory and quality professionals, should monitor progress to assess implications for device approval pathways.
Disclaimer
This article is intended for informational purposes and does not constitute legal or medical advice. Always consult regulatory frameworks and clinical experts before making decisions.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07209397?term=medical+device