Abstract Introduction Contraindications, intolerability and failure to respond make phosphodiesterase type 5 inhibitors (PDE5i) a less than ideal ED treatment strategy. Vacuum erection devices (VEDs) are a commonly used alternative, although they have variable user satisfaction and compliance rates. Objective This study aimed to evaluate the effect of the Vaxaid Hydropump VED on erection firmness and duration improvement, after a sustained period of device use. Methods We conducted a prospective observational study of men aged 30–75 years with mild to moderate erectile dysfunction (ED), defined by an Erection Hardness Score (EHS) of 2–3. Participants were provided with the Vaxaid Hydropump and the FirmTech TechRing wearable device; patients recorded 4 nights at baseline before using the VED, which was used for 14 weeks 3 times a week, additionally they recorded with the Firmtech device 3 times a week as well. Data on nocturnal and sexual erections was analyzed using descriptive statistics. Results In this ongoing trial, 14 men have completed the study to date. Mean age = 55 years (± 8.2). 64% had EHS = 3 at baseline. When comparing the number of nocturnal erections at baseline (median 2.5, IQR 1.5-3.50) and after 14 weeks (median 3, 2.25-4.00), there was a statistically significant increase of 12% in number of nocturnal erections (p = 0.038). Similarly, the total duration of nocturnal erections per night showed a significant increase of 11%, from 127 (SD, 49) to 142 (SD, 49) minutes (p = 0.019). Both measures exhibited large effect sizes (r = 0.35 and 0.39, respectively). Average nocturnal firmness and maximal nocturnal firmness increased by 5% and 4%, respectively; however, these changes did not reach statistical significance. Conclusions Preliminary data from this study highlights the use of the Vaxaid Hydropump VED associated with significant improvements in both the frequency and total duration of nocturnal erections after 14 weeks of regular use, suggesting a potential restorative effect on erectile function. Although changes in firmness did not reach statistical significance, the observed trends and large effect sizes indicate clinically meaningful benefit Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Firmtech
Hernandez et al. (Mon,) studied this question.