Erectile dysfunction (ED), or the inability to get and maintain an erection long enough for a satisfactory sexual experience, is common and varies in severity. Low-intensity shockwave therapy (LiST) may improve ED, especially mild to moderate cases. This noninvasive treatment involves applying low-energy shockwaves to the penis to improve blood flow and promote tissue regeneration. It aims to enhance erectile function in men with vasculogenic ED. The sessions are typically short and conducted over several weeks.

Nevertheless, severe ED, particularly in patients unresponsive to standard treatments like PDE5 inhibitors (ED medications), is harder to treat. Combining LiST with daily low-dose tadalafil (a medication that increases blood flow) might help. Therefore, a new study tested whether adding LiST to tadalafil improves erectile function in patients with severe ED who partially respond to PDE5 inhibitors. The trial aimed to find a safe and effective combined treatment for severe ED.

The study was conducted at a clinic, approved by an ethics board, and registered online. Men aged 40-70 years with severe vasculogenic ED that was partially responsive to PDE5 inhibitors, were included in the study. Any men who had had significant pelvic or penile surgery, abnormal testosterone levels, and severe health conditions were excluded.

Ultimately, 51 sexually active men participated in the trial. The participants were randomly assigned to receive either LiST or a sham treatment (placebo) combined with daily tadalafil for four weeks. Both treatments looked and felt the same to the patients, so neither group was aware of whether they were receiving LiST or the sham treatment. Participants recorded their sexual activity and were evaluated one and three months after treatment. The main goal of the researchers was to see if erectile function improved more in the LiST group compared to the sham group.

Data analysis was used to compare results between the two groups, considering any side effects. The sample size was calculated to ensure the study could detect meaningful differences in outcomes.

Both groups had similar baseline characteristics, and most had cardiovascular issues. After 4 weeks of treatment, the group receiving LiST and tadalafil showed significant improvement in erectile function compared to the placebo group at both 1 and 3 months, according to the men’s respective International Index of Erectile Function (IIEF) scores. However, there was no significant difference in the proportion of successful sexual intercourse attempts between the groups. Some mild pain was reported with LiST, but no serious side effects occurred.

This study found that combining LiST with daily tadalafil improved severe ED more than tadalafil alone in the short term.

Nonetheless, the strict selection criteria for participants, including those with severe cardiovascular issues and long-term ED, may have influenced the results. Although LiST combined with tadalafil showed some benefits, it was less effective than high-dose PDE5 inhibitors alone. The study suggests that LiST could help delay disease progression but further research is needed to confirm its long-term effectiveness and potential benefits. Limitations include a small sample size, short follow-up period, and the study being conducted at a single center.

References:

• Kalyvianakis, D., Mykoniatis, I., Pyrgidis, N., Kapoteli, P., Zilotis, F., & Hatzichristou, D. (2024). The effect of combination treatment with low-intensity shockwave therapy and daily tadalafil on severe erectile dysfunction: A double-blind, randomized, sham-controlled clinical trial. The Journal of Sexual Medicine, 21(6), 533–538. https://doi.org/10.1093/jsxmed/qdae038