The safety and patients satisfaction of the urinary automatic catheter valve, Mirovalve® in patients with urinary catheter: A randomized clinical trial study

Abstract

Background

Urinary tract infections (UTIs) are a significant concern for catheterized patients. Catheter valves have been explored as an alternative to traditional drainage bags, with some studies suggesting improved comfort and a potential reduction in UTIs. This study investigated the Mirovalve®, an automatic catheter valve, in a randomized controlled trial. Our objective was to compare the safety, patient satisfaction, and UTI incidence between the Mirovalve® and standard drainage bags.

Methods

This randomized clinical trial involved 65 patients with urinary retention requiring catheterization, who were also using diapers due to their underlying condition. The study was conducted in the urology clinics of Tabriz University of Medical Sciences after obtaining informed consent from eligible participants. Patients were randomly assigned to either the control group (urinary catheter connected to a drainage bag) or the therapy group (urinary catheter connected to the Mirovalve® automatic catheter valve). The primary outcomes were safety, assessed by urine culture results at the end of the three-week intervention, and patient satisfaction. Secondary outcomes included the incidence and nature of adverse events. A negative urine culture was confirmed before the study commenced.

Results

All 65 participants completed the three-week follow-up. Patient satisfaction was significantly higher in the Mirovalve® group compared to the drainage bag group (P < 0.001). A large majority of Mirovalve® users (73.6 %) reported being "very" or "extremely" satisfied, versus only 9.7 % of the drainage bag users. The overall incidence of adverse events was similar between the groups, although two patients in the Mirovalve® group experienced temporary acute urinary retention. The incidence of symptomatic UTIs was significantly lower in the Mirovalve® group (12.9 %) compared to the drainage bag group (46.2 %) (P = 0.025).

Conclusion

Our findings indicate that the Mirovalve® automatic catheter valve is associated with significantly higher patient satisfaction and a lower incidence of UTIs compared to standard drainage bags. While both methods showed similar short-term safety profiles, the improved satisfaction with the Mirovalve® highlights its potential to enhance patient quality of life. These results suggest that the Mirovalve® is a valuable option for catheter-dependent patients, though further research is needed to confirm these findings over a longer duration and in more diverse populations.