The efficiency of biofeedback electric stimulation therapy combined with low-intensity pulsed ultrasound in treating erectile dysfunction: a clinical study

La eficiencia de la terapia de estimulación eléctrica de biofeedback combinada con ultrasonido pulsado de baja intensidad en el tratamiento de la disfunción eréctil: un estudio clínico

Background: Erectile dysfunction (ED) is a prevalent condition that significantly impacts the quality of life of both patients and their partners. Current therapeutic approaches often struggle to address the diverse needs of all patients. In addition, the efficacy of low-intensity pulsed ultrasound (LIPUS) in improving ED symptoms has been insufficiently investigated. Therefore, this study aims to evaluate the effectiveness of LIPUS and to assess whether combining LIPUS with biofeedback electric stimulation for pelvic floor therapy enhances treatment outcomes. Methods: We retrospectively retrieved and assessed the data of 68 patients treated at West China Fourth Hospital. Of them, 30 patients received LIPUS therapy alone, while 38 underwent combined therapy of LIPUS and biofeedback electric stimulation. Both groups completed eight treatment sessions. Results: After the treatment, the efficacy of the treatments was measured using the International Index of Erectile Function-5 (IIEF-5), Erectile Hardness Score (EHS), and Erection Satisfaction Score (ESS) after 4 and 8 treatments. Significant improvements were observed in the LIPUS-only group in IIEF-5, EHS and ESS scores (p < 0.001 for all measures). The positive response rate was 79.41% after eight treatments. Improvements in IIEF-5 scores were observed in both groups (LIPUS: 11.50 to 16.60; combined therapy: 10.61 to 16.90; p < 0.001), as well as in EHS scores (LIPUS: 2.27 to 3.07; combined therapy: 2.26 to 3.11; p < 0.001). However, no statistically significant differences were found between the LIPUS-only and combined therapy groups (p > 0.05). Conclusions: LIPUS therapy demonstrates potential for alleviating ED symptoms, and the addition of biofeedback electric stimulation for pelvic floor therapy did not result in significantly superior outcomes compared to LIPUS alone. Further research with larger sample sizes and longer treatment durations is necessary to confirm these results.

Resumen

Antecedentes: La disfunción eréctil (DE) es una condición prevalente que impacta significativamente en la calidad de vida de los pacientes y sus parejas. Los enfoques terapéuticos actuales a menudo tienen dificultades para abordar las diversas necesidades de todos los pacientes. Además, la eficacia del ultrasonido pulsado de baja intensidad (LIPUS) en la mejora de los síntomas de DE ha sido insuficientemente investigada. Por lo tanto, este estudio tiene como objetivo evaluar la efectividad de LIPUS y determinar si combinar LIPUS con estimulación eléctrica de biofeedback para la terapia del suelo pélvico mejora los resultados del tratamiento. Métodos: Recuperamos y evaluamos retrospectivamente los datos de 68 pacientes tratados en el Cuarto Hopsital del oeste de China. De ellos, 30 pacientes recibieron solo terapia con LIPUS, mientras que 38 se sometieron a una terapia combinada de LIPUS y estimulación eléctrica de biofeedback. Ambos grupos completaron ocho sesiones de tratamiento. Después del tratamiento, la eficacia de los tratamientos se midió utilizando el Índice Internacional de Función Eréctil-5 (IIEF-5), el Puntaje de Dureza Eréctil (EHS) y el Puntaje de Satisfacción de Erección (ESS) después de 4 y 8 tratamientos. Resultados: Se observaron mejoras significativas en el grupo solo de LIPUS en los puntajes de IIEF-5, EHS y ESS (p < 0.001 para todas las medidas). La tasa de respuesta positiva fue del 79.41% después de ocho tratamientos. Conclusiones: Se observaron mejoras en los puntajes de IIEF-5 en ambos grupos (LIPUS: 11.50 a 16.60; terapia combinada: 10.61 a 16.90; p < 0.001), así como en los puntajes de EHS (LIPUS: 2.27 a 3.07; terapia combinada: 2.26 a 3.11; p < 0.001). Sin embargo, no se encontraron diferencias estadísticamente significativas entre el grupo solo de LIPUS y el grupo de terapia combinada (p > 0.05). En conclusión, la terapia con LIPUS muestra potencial para aliviar los síntomas de DE, y la adición de estimulación eléctrica de biofeedback para la terapia del suelo pélvico no resultó en resultados significativamente superiores en comparación con LIPUS solo. Se necesita más investigación con tamaños de muestra más grandes y duraciones de tratamiento más largas para confirmar estos resultados.

Low-intensity pulsed ultrasound; Biofeedback electric therapy stimulation for pelvic; Erectile dysfunction

Palabras Clave

Ultrasonido pulsado de baja intensidad; Estimulación eléctrica de biofeedback para el suelo pélvico; Disfunción eréctil

[1] Salonia A, Bettocchi C, Boeri L, Capogrosso P, Carvalho J, Cilesiz NC, et al. European association of urology guidelines on sexual and reproductive health-2021 update: male sexual dysfunction. European Urology. 2021; 80: 333–357.

[2] Li MK, Garcia LA, Rosen R. Lower urinary tract symptoms and male sexual dysfunction in Asia: a survey of ageing men from five Asian countries. BJU International. 2005; 96: 1339–1354.

[3] Ludwig W, Phillips M. Organic causes of erectile dysfunction in men under 40. Urologia Internationalis. 2014; 92: 1–6.

[4] Ayta IA, McKinlay JB, Krane RJ. The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU International. 1999; 84: 50–56.

[5] Pantazis A, Franco I, Gitlin J. Erectile dysfunction in adolescents and young adults. Current Urology Reports. 2024; 25: 225–232.

[6] Xiong Y, Zhang F, Zhang Y, Wang W, Ran Y, Wu C, et al. Insights into modifiable risk factors of erectile dysfunction, a wide-angled Mendelian Randomization study. Journal of Advanced Research. 2024; 58: 149–161.

[7] Sivaratnam L, Selimin DS, Abd Ghani SR, Nawi HM, Nawi AM. Behavior-related erectile dysfunction: a systematic review and meta-analysis. The Journal of Sexual Medicine. 2021; 18: 121–143.

[8] Defeudis G, Mazzilli R, Tenuta M, Rossini G, Zamponi V, Olana S, et al. Erectile dysfunction and diabetes: a melting pot of circumstances and treatments. Diabetes/Metabolism Research and Reviews. 2022; 38: e3494.

[9] Terentes-Printzios D, Ioakeimidis N, Rokkas K, Vlachopoulos C. Interactions between erectile dysfunction, cardiovascular disease and cardiovascular drugs. Nature Reviews Cardiology. 2022; 19: 59–74.

[10] Selvin E, Wang D, Tang O, Fang M, Christenson RH, McEvoy JW. Elevated cardiac biomarkers, erectile dysfunction, and mortality in U.S. men: NHANES 2001 to 2004. JACC: Advances. 2023; 2: 100380.

[11] Moncada I, Martinez-Salamanca JI, Allona A, Hernandez C. Current role of penile implants for erectile dysfunction. Current Opinion in Urology. 2004; 14: 375–380.

[12] Argiolas A, Argiolas FM, Argiolas G, Melis MR. Erectile dysfunction: treatments, advances and new therapeutic strategies. Brain Sciences. 2023; 13: 802.

[13] Qin H, Luo Z, Sun Y, He Z, Qi B, Chen Y, et al. Low-intensity pulsed ultrasound promotes skeletal muscle regeneration via modulating the inflammatory immune microenvironment. International Journal of Biological Sciences. 2023; 19: 1123–1145.

[14] Liu X, Zou D, Hu Y, He Y, Lu J. Research progress of low-intensity pulsed ultrasound in the repair of peripheral nerve injury. Tissue Engineering Part B: Reviews. 2023; 29: 414–428.

[15] Chen R, Du W, Zhang X, Xu R, Jiang W, Zhang C, et al. Protective effects of low-intensity pulsed ultrasound (LIPUS) against cerebral ischemic stroke in mice by promoting brain vascular remodeling via the inhibition of ROCK1/p-MLC2 signaling pathway. Cerebral Cortex. 2023; 33: 10984–10996.

[16] Lin Z, Gao L, Hou N, Zhi X, Zhang Y, Che Z, et al. Application of low-intensity pulsed ultrasound on tissue resident stem cells: potential for ophthalmic diseases. Frontiers in Endocrinology. 2023; 14: 1153793.

[17] Palanisamy P, Alam M, Li S, Chow SKH, Zheng YP. Low-intensity pulsed ultrasound stimulation for bone fractures healing: a review. Journal of Ultrasound in Medicine. 2022; 41: 547–563.

[18] Leighton R, Phillips M, Bhandari M, Zura R. Low intensity pulsed ultrasound (LIPUS) use for the management of instrumented, infected, and fragility non-unions: a systematic review and meta-analysis of healing proportions. BMC Musculoskeletal Disorders. 2021; 22: 532.

[19] Li Z, Ye K, Yin Y, Zhou J, Li D, Gan Y, et al. Low-intensity pulsed ultrasound ameliorates erectile dysfunction induced by bilateral cavernous nerve injury through enhancing Schwann cell-mediated cavernous nerve regeneration. Andrology. 2023; 11: 1188–1202.

[20] Myers C, Smith M. Pelvic floor muscle training improves erectile dysfunction and premature ejaculation: a systematic review. Physiotherapy. 2019; 105: 235–243.

[21] Alouini S, Memic S, Couillandre A. Pelvic floor muscle training for urinary incontinence with or without biofeedback or electrostimulation in women: a systematic review. International Journal of Environmental Research and Public Health. 2022; 19: 2789.

[22] Kannan P, Winser SJ, Fung B, Cheing G. Effectiveness of pelvic floor muscle training alone and in combination with biofeedback, electrical stimulation, or both compared to control for urinary incontinence in men following prostatectomy: systematic review and meta-analysis. Physical Therapy & Rehabilitation Journal. 2018; 98: 932–945.

[23] Lei H, Xin H, Guan R, Xu Y, Li H, Tian W, et al. Low-intensity pulsed ultrasound improves erectile function in streptozotocin-induced type i diabetic rats. Urology. 2015; 86: 1241.e11–e18.

[24] Lin G, Reed-Maldonado AB, Lin M, Xin Z, Lue TF. Effects and mechanisms of low-intensity pulsed ultrasound for chronic prostatitis and chronic pelvic pain syndrome. International Journal of Molecular Sciences. 2016; 17: 1057.

[25] Cui W, Li H, Guan R, Li M, Yang B, Xu Z, et al. Efficacy and safety of novel low-intensity pulsed ultrasound (LIPUS) in treating mild to moderate erectile dysfunction: a multicenter, randomized, double-blind, sham-controlled clinical study. Translational Andrology and Urology. 2019; 8: 307–319.

[26] Ferreira CH, Dwyer PL, Davidson M, De Souza A, Ugarte JA, Frawley HC. Does pelvic floor muscle training improve female sexual function? A systematic review. International Urogynecology Journal. 2015; 26: 1735–1750.

[27] Parra NS, Jaramillo AP, Zambrano J, Segovia D, Castells J, Revilla JC. The effectiveness of pelvic floor muscle exercise in urinary incontinence: a systematic literature review and meta-analysis. Cureus. 2023; 15: e45011.

[28] Liu Y, Pan XY, Zhang XX, Sun JL, Mao YH, Yang Y, et al. Role of mechanotransduction mediated by YAP/TAZ in the treatment of neurogenic erectile dysfunction with low-intensity pulsed ultrasound. Andrology. 2023; 11: 1514–1527.

[29] Chen Y, Xiao M, Zhao L, Huang Y, Lin Y, Xie T, et al. Low-intensity pulsed ultrasound counteracts advanced glycation end products-induced corpus cavernosal endothelial cell dysfunction via activating mitophagy. International Journal of Molecular Sciences. 2022; 23: 14887.

[30] Chen H, Li Z, Li X, Yang Y, Dai Y, Xie Z, et al. The efficacy and safety of thrice vs twice per week low-intensity pulsed ultrasound therapy for erectile dysfunction: a randomized clinical trial. The Journal of Sexual Medicine. 2022; 19: 1536–1545.

[31] Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. European Urology. 2011; 60: 1010–1016.