This study aimed to evaluate the safety and patient satisfaction associated with the use of an automatic catheter valve (Mirovalve®) compared to traditional drainage bags in patients requiring long-term urinary catheterization. The primary hypothesis was that the automatic catheter valve would result in improved patient satisfaction. A secondary hypothesis was that the automatic catheter valve would lead to a reduction in the incidence of urinary tract infections (UTIs).

This randomized clinical trial aimed to investigate the use of a urinary catheter for 65 patients who need to use diapers and cannot urinate. The study was conducted in the urology clinics of Tabriz University of Medical Sciences, with informed consent obtained from eligible women. The participants were divided into two groups: control (urinal catheter connected to the drainage bag) and therapy (urinal catheter connected to the urinary automatic catheter valve). Primary outcomes were safety and patient satisfaction, while secondary outcomes were possible adverse events. A urine culture was performed to eliminate bladder irritation due to urinary tract infection, and the study protocol was started only after a negative urine culture was repeated. The automatic catheter valve was used for three weeks, and after three weeks, patients were checked again for urinary tract infections.

The study involved 65 patients divided into two groups, with most being male. Urinalysis results showed positive urinalysis results in the urinary automatic catheter valve group, while drainage bag patients had positive urine cultures. Side effects were similar in both groups, with urinary retention being the main cause. Lower abdominal and groin pain was reported in both groups. Despite these side effects, there was no significant difference in patient satisfaction with the intervention. The satisfaction level of patients using the automatic catheter valve was significantly higher than the other group (Figure 1).

The results of this study indicate that the automatic catheter valve (Mirovalve®) offers a significant advantage in terms of patient satisfaction compared to traditional drainage bags.  Patients using the valve reported a higher level of comfort and convenience, which likely contributed to their greater overall satisfaction. While the overall incidence of adverse events was similar in both groups, the occurrence of urinary retention in two patients in the valve group highlights a potential risk associated with its use. However, this was a relatively small number of cases.  The follow-up urine culture results showed a numerical difference, with fewer positive cultures in the valve group at the end of the study period. Although this difference was not statistically significant, it suggests a potential trend towards a lower incidence of UTIs with the automatic catheter valve.  Larger studies may be needed to confirm this finding. The higher proportion of males in the valve group is a limitation of the study. However, the primary outcome of patient satisfaction was significantly in favor of the valve, suggesting that the valve may be advantageous regardless of sex.

The Mirovalve® Automatic catheter valve offers a significant advantage in patient satisfaction and may contribute to a reduction in UTI rates compared to traditional drainage bags. Both methods exhibited similar safety profiles, except valve-related urinary retention in a small subset of patients. Individualized patient care, considering patient needs, clinical circumstances, and potential risks, is essential. Ongoing education for both patients and healthcare providers regarding the proper use and management of both catheterization methods is crucial for optimal patient outcomes. Further research with larger sample sizes and longer follow-up periods is warranted to confirm the potential benefits of the automatic catheter valve in reducing UTI rates and to further evaluate its long-term safety and efficacy.