Published on January 10, 2026: Relief srl has announced the status for its monocentric pilot clinical trial evaluating the application of the UroRelief device, a sterile, single-use, endourethral device designed to address stress urinary incontinence in both men and women. While the trial is now in the “active, not recruiting” phase, this development highlights potential advancements in non-invasive management of stress incontinence, a significant clinical challenge.
What is UroRelief?
The UroRelief device is a sterile, single-use endourethral device developed by Relief srl. It is designed for placement at the bladder neck to mitigate stress urinary incontinence. The device is indicated for use in both male and female patients, which makes it a versatile solution addressing a broad patient population.
Stress urinary incontinence, characterized by involuntary leakage of urine during physical activities such as coughing or exercising, lacks universally effective non-invasive treatments. The specific placement of UroRelief aims to reduce leakage by improving control at the bladder neck.
Clinical Study Status
The clinical trial evaluating UroRelief has reached the “active, not recruiting” phase. This designation means the study is ongoing, with all required participants already enrolled. The focus of this monocentric study is to assess the safety, usability, and initial performance of the device within a controlled environment.
This pilot trial forms a foundational step toward further studies and eventual broader regulatory submissions. Studies such as this are critical for refining device applications and ensuring compliance with regulatory standards, including the EU MDR’s emphasis on clinical evidence and post-market surveillance.
Potential Benefits of UroRelief
The UroRelief device offers a potential alternative to surgical or pharmacological interventions, which are commonly used to manage stress urinary incontinence but are often associated with complications or limited efficacy. Key potential benefits include:
- Non-invasive treatment option, reducing patient recovery time.
- Suitability for a diverse patient demographic, including both men and women.
- Single-use sterile design, minimizing infection risk during insertion.
While these benefits are promising, it is essential that results from this pilot study confirm safety and efficacy before the device progresses to broader clinical deployment.
Frequently Asked Questions
- What is the intended use of the UroRelief device?
The device is intended to treat stress urinary incontinence through support provided at the bladder neck. - Is the trial conducted globally?
This is a monocentric pilot study, meaning it is being conducted at a single trial site. - When can the device be expected on the market?
Market availability will depend on additional clinical studies, regulatory submissions, and approvals. - Who sponsors the trial?
Relief srl serves as the official sponsor of the UroRelief trial.
Conclusion
The monocentric pilot study of UroRelief signifies a promising advancement in the management of stress urinary incontinence. Relief srl’s innovative approach targets improving patient outcomes with a simple, sterile, and non-invasive solution. Clinical, quality, and regulatory experts alike should monitor the device’s progress as further data becomes available.
Disclaimer
This article is intended for information purposes only and does not constitute legal or regulatory advice. Always consult relevant guidance from your jurisdiction’s competent authority.
Further Information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07327528?term=medical+device