INTRODUCTION: Extracorporeal shock wave lithotripsy (SWL) is a standard of care for the management of urinary stones up to 2 cm. Although it is generally well-tolerated, ESWL can be a painful procedure for some patients. Virtual reality devices (VRDs) have recently proven to be useful in reducing patient-reported pain during SWL. This study aims to evaluate the safety and efficacy of a VRD during SWL in a case-control study. MATERIALS AND METHODS: We retrospectively analyzed data of patients undergoing SWL at a single academic stone center. According to patient preference and device availability, a number of procedures were performed using a VRD (HypnoVR®, Strasbourg, France). Patients who underwent more than one SWL session, with at least one session using a VRD, were enrolled in a case-control study (Group 1: SWL with VRD, and Group 2: SWL without VRD). Peri-procedural data were collected. A visual analogue scale (VAS) was used to measure pain tolerance. Descriptive statistics, Chi-squared test and t-test were used to compare the 2 cohorts. RESULTS: A total of 103 procedures with VRD were performed, and 69 procedures were included in the control group. No significant differences in terms of sex, age, BMI, and comorbidities were found between the two groups. In Group 1, the median (IQR) stone volume was 109 (78-189) mm³ with a median (IQR) density of 1100 (900-1400) HU, and the stone was located in the kidney in 56 (54%) patients. In the control group, the median (IQR) stone volume was 164 (104-245) mm³, the median (IQR) density was 1195 (918-1356), and stones located in the kidney in 42 (61%) patients. The median (IQR) number of shock waves was 2831 (2377-3004) in the VRD group versus 2622 (2287-3001) in the control group. The median (IQR) VAS score was comparable between the 2 cohorts: 5 (3-6) in Group 1 and 5 (2-5) in Group 2. No VRD-related side effects or interruptions have been reported. CONCLUSION: This study confirms that the use of VRD during SWL is safe, feasible and well-tolerated. However, current results do not demonstrate a reduction in pain during the procedure compared to a control group. VRD may be proposed to patients undergoing SWL.