Stimuli Technology has announced the initiation of the Tensi+ European Registry, a clinical trial aimed at evaluating the device’s effectiveness for patients with overactive bladder (OAB). This registry highlights an important step toward collecting real-world evidence for Tensi+, a medical device designed to improve quality of life in individuals who suffer from this condition. Researchers, clinicians, and regulatory teams will find this development noteworthy as it could shape future therapies and regulatory pathways for OAB management.
In this article:
- What changed?
- Why this registry matters
- Key details about Tensi+ and the trial
- FAQ
- Conclusion
- Disclaimer
- Official announcement and link
What changed?
On October 5, 2025, Stimuli Technology shared an update announcing that the Tensi+ European Registry is now recruiting participants on ClinicalTrials.gov. This indicates a significant focus on utilizing Tensi+, a medical device intervention, for individuals diagnosed with OAB. The registry aims to gather robust outcomes from device usage in a real-world clinical setting.
Why this registry matters
Overactive bladder is a commonly reported condition, yet many patients experience challenges in obtaining effective management due to limited device-based therapies. Tensi+ seeks to address this gap through advanced technology that targets specific symptoms, such as frequent urination and urgency.
The registry focuses on outcomes that can provide deeper insights into Tensi+’s performance, safety, and overall patient impact. This is especially relevant for regulatory and clinical teams, who often rely on real-world data alongside controlled trials to assess long-term device efficacy.
Key details about Tensi+ and the trial
What is Tensi+?
Tensi+ is a medical device developed by Stimuli Technology to assist patients with overactive bladder. According to the sponsor, the device has been engineered with the aim of improving bladder control and reducing OAB-related symptoms.
Who can participate?
The registry targets individuals diagnosed with OAB who meet specific inclusion criteria set by researchers. It is currently noted to be in a recruiting phase. Clinical professionals are encouraged to review the trial description on ClinicalTrials.gov for further details.
What outcomes will be measured?
The focus of this registry includes evaluating Tensi+ in terms of effectiveness, patient adherence, and device safety over time. This data might help refine regulatory submissions and guide further clinical development.
Who sponsors the study?
Stimuli Technology sponsors the Tensi+ registry, taking a proactive approach to meet European standards for clinical evidence generation. The findings may also support broader discussions about medical device innovation for OAB.
FAQ
1. Who is eligible for the Tensi+ European Registry?
Patients diagnosed with overactive bladder and meeting the criteria outlined in the trial documentation are eligible.
2. How does Tensi+ address OAB symptoms?
According to Stimuli Technology, Tensi+ uses innovative mechanisms to assist in bladder control, targeting the condition’s core symptoms such as urgency and frequency.
3. Where is the trial taking place?
The registry is focused on recruiting participants across Europe. Full details will be available via designated clinical trial centers.
Conclusion
The Tensi+ registry marks an important milestone in addressing OAB through device-based solutions. Regulatory and clinical teams should monitor its progress for insights into product performance and patient outcomes. If successful, it may set new benchmarks for non-pharmacological interventions in bladder management.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Professionals are encouraged to consult relevant documentation and experts for specific guidance.
Official announcement and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07205445?term=medical+device