Contextualization: Emptying the bladder is a challenging problem for the urological community. Intermittent catheterization is the most widely used method to restore bladder emptying mechanism. However, this procedure can have a negative impact on self-image and result in a decline in the quality of life of patients. In this context, the use of a bladder emptying device (SVCATH3D) proposes to be effective and have a positive impact on the quality of life of different patients. Objective: The objective of the study was to evaluate the functionality of a new device for both intermittent and controlled emptying of the bladder in both sexes and ages. Materials and methods: A randomized clinical trial was conducted with 251 patients, with different bladder problems, from March 2013 to January 2023. After randomization, the patients were divided into two groups: Group I (SVCATH3D) and Group II (Clean Intermittent Catheterization). The primary outcome was defined as the impact on quality of life. Data on episodes of urinary tract infection, adverse effects, number of diaper use and treatment costs were analyzed. Results: The apposition of the SVCATH3D was performed on an outpatient basis, with no complications during the procedures. The patients were followed up for 10 years. There was a significant improvement in quality of life when comparing the moments before and after the use of SVCATH3D (p < 0.001), as well as there was a significant reduction in the number of episodes of urinary tract infection (p < 0.001), absent serious adverse effects and a reduction in the number of diapers or daily protectors. Conclusion: The study using SVCATH3D showed promising results in relation to functionality, showing improvement in quality of life with a reduction in episodes of urinary infection and amount of diapers/day. This allows us to conclude that SVCATH3D can represent an important step in the treatment of patients suffering from various bladder problems both incontinence and affecting emptying mechanism.
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