Role of Extracorporeal Shock Wave Therapy in Patients with Angiogenic Erectile Dysfunction Associated with Diabetes Mellitus Refractory to Pharmacotherapy: A Prospective Observational Study

Introduction: Erectile Dysfunction (ED) has a strong association with diabetes mellitus in men. The role of Extracorporeal Shock Wave Therapy (ESWT) in patients with ED is being evaluated and used as a treatment option by many urologists. It is considered a treatment modality intermediary between pharmacotherapies and prosthesis surgery. Literature on ESWT in patients with Diabetes Mellitus (DM) refractory to pharmacotherapy remains scarce. Aim: To evaluate the role of ESWT in patients with angiogenic ED associated with diabetes mellitus refractory to pharmacotherapy. Materials and Methods: The prospective observational study was carried out in the Outpatient Department of Urology (OPD) of Ruby Hall Clinic, Pune, Maharashtra, India between February 2020 and September 2021 on 40 patients fulfilling the inclusion criteria. Total 20 patients in each were randomised to the control group, and the ESWT group in a ratio of 1:1. Each patient was evaluated pre- and post-ESWT with colour Doppler imaging of the penis after injecting 30 mg to 40 mg of papaverine intracavernosally. Validated sexual function questionnaires such as the International Index of Erectile Function (IIEF)- Erectile Function (EF) domain, Sexual Health Inventory for Men (SHIM), and Erectile Hardness Score (EHS) were used. The IIEF questionnaire was administered to each patient at baseline, 3 months, 6 months, 9 months, and 12 months. Colour Doppler imaging of the penis, SHIM score, and EHS score were used to evaluate each patient at baseline, 6 months, and 12 months. Data were collected and tabulated in a Microsoft Excel sheet. Results were presented as mean±standard deviation. Repeated Analysis of Variance (ANOVA) tests, paired t-tests, and independent sample t-tests were utilised in the study. A p-value of less than 0.05 was considered statistically significant. Results: The most common age group among the study population was 41 to 50 years (40%). When comparing the mean IIEF score- EF domain between the ESWT and control groups at 3, 6, 9, and 12 months, the difference was statistically significant (p-values obtained at 3, 6, 9, and 12 months were 0.009, 0.0001, 0.0001, and 0.0001, respectively). Comparing the mean SHIM score and EHS between the ESWT and control groups at 6 and 12 months, the difference was statistically significant (for SHIM score, p-values obtained at 6 and 12 months were 0.005 and 0.0001 respectively; for EHS, p-values obtained at 6 and 12 months were 0.0008 and 0.0001 respectively). The improvement in mean peak systolic velocity of the right and left cavernosal arteries at 6 months and 12 months was statistically significant in the ESWT group compared to the control group (p-value=0.001). Conclusion: The ESWT for ED in diabetic patients is a novel treatment option with promising results. Clinicians and patients need to be aware about the various management strategies available for diabetic individuals who have not had success with pharmacotherapy alone.