97 - A Minimally Invasive Endo-Urethral Device for Stress Urinary Incontinence - a first human study

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Hypothesis / aims of study Stress urinary incontinence (SUI) is a common condition, which affects patients’ quality of life, and is associated with significant implications for healthcare system resources. The most severe cases of SUI are treated with the implantation of artificial urinary sphincters [1] . The authors propose an innovative minimally invasive endo-urethral device (UroRelief) for the treatment of these patients. Study design, materials and methods The procedure utilizes an endo-urethral device positioned into the urethra through a standard cystoscopic procedure and local anaesthesia. The key element of the device is a silicone valve that replaces the function of the biological external urinary sphincter. The device valve is activated when the patient contracts the abdomen, resulting in the opening of the valve and the ability to void. The valve is incorporated in a Titanium frame that has the function of ensuring the proper anchoring and stability of the device. The shape memory behavior of Nitinol stents mounted on the device extremities allow easy insertion of the UroRelief valve, at the same time providing stability and device retention, once the valve is deployed. Results UroRelief has been tested on bench-test, ex-vivo tests on human cadavers, and in-vivo tests on 16 humans by means of two pilot studies. A first-in-human study was conducted involving 6 incontinent patients for 28 days to evaluate the device design concept with respect to initial clinical safety and device functionality [2] . Following investigator and patients’ feedback, the device was partly re-designed. The modified device has recently been tested by means of a second pilot study (10 patients) for 3 months in a multicenter clinical trial in Italy (3 centers) [3] . The second study results are presented below. Finally, a third pilot study is expected to start on September 2025. Interpretation of results In the second pilot study, device insertion was successfully performed in 8/10 patients. No issues with ease of insertion or removal were reported. Two patients were excluded from the study due to issues caused by deviations from the protocol's inclusion and exclusion criteria. Their exclusion was not related to any adverse events associated with the device or the procedure Patients experienced good to excellent continence restoration (i.e. urine losses were reduced between 59% and 99%), and good tolerability (i.e. no patients reported pain, seven patients reported slight discomfort, and one patient reported discomfort). The majority (8/10) of patients were discharged with the device located in situ, and they ended the study after 90 days with a properly working device. Some mild encrustations were observed in the Titanium frame and/or Nitinol stents without affecting performance or complicating the explant procedure. None of the patients required urgent intervention, and no UTIs were reported during the study. No serious adverse events were reported. Quality of life was considerably improved in the majority (8/10) of the cases with a reduction of urine loss up to 99%. Questionnaires demonstrated no chronic effects or no negative changes in the quality of life caused by the device insertion, no chronic discomfort or pain, no irritative effects, and no changes in urination frequency. Concluding message In conclusion this multicentre pilot study with the re-designed UroRelief device demonstrates its efficacy in addressing SUI, guaranteeing low invasiveness, and improving urinary continence in the majority of subjects. The improved design allowed for ease of insertion and maintenance of positioning without migration. The device has a promising future clinical application. Funding The study is supported by Relief a spinoff of Scuola Superiore Sant'Anna Clinical Trial Yes Registration Number NCT05449639 RCT No Subjects Human Ethics Committee Comitato Etico Campus Biomedico Roma Helsinki Yes Informed Consent Yes

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