To evaluate the efficacy and safety of a non-invasive low-frequency tibial nerve stimulator (TNS-01) vs sham control in relieving the symptoms of overactive bladder (OAB) patients. Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly. The subjects were 1:1randomized (block randomization with a block size of 4) to either active treatment (TNS-01 group) or sham treatment (sham group). Based on the randomization, the subject will be given either an active or sham device system (systems will only differ in the Instructions for Use and electrode size/shape). During the 12-week study period, all participants underwent three 30-min intervention sessions weekly. The primary endpoint was the change in Overactive Bladder Symptom Score (OABSS) at week 12 from the baseline. Of the 109 recruited OAB patients. In the TNS-01 group, the OABSS change from baseline at week 12 was significantly higher than that in the sham group (2.83 ± 2.53 vs 1.62 ± 2.59, p = 0.02). The absolute and percent changes of average UUI episodes per day from baseline at week 8 in the TNS-01 group were significantly lower from those in the sham group (0.11 ± 1.33 vs 0.68 ± 2.14, p = 0.01; − 27.82% ± 167.33% vs 87.18% ± 25.20%, p = 0.04). One treatment-related adverse event (hematuria) was reported by one patient (1.8%) in the sham group. The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation. Trial registration number: NCT04999657.

Objective: Few studies have examined the relationship between systemic oxidative stress and prostate cancer (PCa) risk. This study aimed to explore potential correlations between PCa and oxidative balance score (OBS), which measures systemic oxidative stress. Design: A cross-sectional study. Setting: The National Health and Nutrition Examination Survey. Participants: A total of 8156 individuals were included in this study. Primary and secondary outcome measures: Weighted logistic regression with multivariable adjustment and restricted cubic splines (RCS) were used to assess the correlation between PCa and OBS. A sensitivity analysis was conducted specifically on patients with PCa to verify the results. Results: The prevalence of PCa was 2.55%. The multivariable logistic regression model revealed no correlation between OBS, dietary OBS, lifestyle OBS and PCa. Compared with the lowest quartile of OBS, the adjusted ORs for the highest quartile of OBS, dietary OBS and lifestyle OBS were 1.852 (95% CI 1.028–3.339), 1.565 (95% CI 0.841–2.913) and 1.575 (95% CI 0.915–2.710), respectively. Additionally, all p values for trend were greater than 0.05. Subgroup analysis revealed a consistent lack of association between OBS and PCa across various population settings. Furthermore, analysis using RCS confirmed this absence of association, indicating no significant relationship in either a linear or non-linear context. A sensitivity analysis focusing exclusively on patients with PCa showed a strong association (OR=2.737, p=0.008). Conclusion: This cross-sectional study reveals no significant association between systemic oxidative stress, measured by OBS, and PCa risk. Notably, a sensitivity analysis focusing solely on PCa patients suggested a potential link, warranting further investigation.