Low-intensity shockwave therapy and pelvic floor muscle training each mitigate erectile dysfunction in men with diabetes: a randomised controlled trial.

QUESTION: What are the effects of low-intensity extracorporeal shockwave therapy (Li-ESWT) and of pelvic floor muscle training (PFMT) on penile blood flow and erectile function in men with type 2 diabetes mellitus and erectile dysfunction (ED)?

DESIGN

Three-arm randomised trial with concealed allocation, assessor blinding and intention-to-treat analysis.

PARTICIPANTS

Ninety subjects aged 35 to 55 years with type 2 diabetes mellitus and arteriogenic ED.

INTERVENTIONS: All groups were on sildenafil treatment: 25 mg daily and 50 mg on demand. The Li-ESWT group received Li-ESWT with an energy flux intensity of 0.09 mJ/mm2 once per week for 6 weeks. The Li-ESWT was applied to six points bilaterally on the ventral aspect of the penile shaft (distal, middle and proximal) and the right and left penile crura. The PFMT group received home-based PFMT for 6 weeks. The control group received only the sildenafil treatment.

OUTCOME MEASURES: The peak systolic velocity (PSV) of the right and left cavernosal arteries and the five-item version of the International Index of Erectile Function (IIEF-5, scored from 5 worst to 25 best) were assessed at baseline and after 6 weeks.

RESULTS

Compared with control, Li-ESWT and PFMT each improved PSV of cavernosal arteries bilaterally and IIEF-5. Compared with PFMT, Li-ESWT improved PSV of cavernosal arteries bilaterally (difference in mean change 10 cm/sec, 95% CI 9 to 11) and IIEF-5 total score (difference in mean change 1.4, 95% CI 0.9 to 1.9).

CONCLUSION

Combined with sildenafil treatment, Li-ESWT may induce a greater increase in penile blood flow and better erectile function than home-based PFMT in middle-aged men with type 2 diabetes mellitus and arteriogenic ED. Nevertheless, home-based PFMT combined with sildenafil treatment may yield greater improvements in these outcomes compared with sildenafil alone in this population. Patients should be informed of the potential benefits, discomforts and inconveniences associated with each treatment to facilitate informed decision-making.

REGISTRATION: NCT06058832.