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Low-intensity extracorporeal shock wave therapy (Li-ESWT) has shown promise as a novel treatment for erectile dysfunction (ED), though the the mechanism of action and optimal protocol for administration has not been well-established. The aim of this study is to assess for subjective and objective improvements in erectile function following treatment with Li-ESWT.
Eligible patients will be enrolled as outlined below. Prior to initiation of Li-ESWT treatments, patients will complete validated questionnaires to assess erectile function. In addition, patients will undergo induction of artificial erection in clinic with assessment of penile blood flow using penile Doppler. Intracavernosal pressure measurements will be obtained. A corporal aspirate will be drawn and examined for levels of neuronal nitric oxide synthase, endothelial nitric oxide synthase, brain-derived neurotropic factor and vascular endothelial growth factor. Patients will then receive twice-weekly Li-ESWT treatments of 0.2mJ/mm^2 over 3 treatment sites along the dorsal penile shaft, 1500 shocks per treatment (500 shocks per treatment site), for a total of 3000 shocks per week, for 6 weeks of treatment (totally 18,000 shocks). Following Li-ESWT treatments, patients will complete the same validated questionnaires, penile Doppler studies, corporal aspirates and measurement of intracavernosal pressures immediately following the final Li-ESWT treatment, 4-6 weeks following completion of treatment, and again at 3 and 6 months following completion of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants will receive twice-weekly Li-ESWT treatments of 0.2mJ/mm² over 3 treatment sites along the dorsal penile shaft (distal, mid-shaft, proximal), 1500 shocks per treatment (500 shocks per treatment site) for a total of 3000 shocks per week, for 6 weeks (total of 18,000 shocks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Intensity Extracorporeal Shock Wave Therapy | Device | Twice-weekly treatments for 6 weeks, of 0.2mL/mm^2 administered for 500 shocks per treatment site, for a total of 3000 shocks per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy | To evaluate the efficacy of the Storz Duolith SD-1 T-top >>ultra<< Li-ESWT device | 12 months |
| Treatment Efficacy | To provide data in support of a standardized protocol for the treatment duration for use of this device in treatment of erectile dysfuntion | 12 months |
| Treatment Efficacy | To provide data in support of a standardized protocol for the treatment dose for use of this device in treatment of erectile dysfuntion | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of improvements in penile corporal tissues | To evaluate for upregulation of nNOS, eNOS, BDNF and VEGF within penile corporal tissue | 12 months |
| Measurement of improvements in penile corporal tissues |
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Inclusion Criteria:
Exclusion Criteria:
Participants will be required to discontinue all erectogenic medications for 1 months prior to initiation of treatment and will not be permitted to use erectogenic medications for the duration of the treatment study.
Participants must be men with erectile disfunction.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VAMC | Richmond | Virginia | 23249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1694604 | Background | Young SR, Dyson M. The effect of therapeutic ultrasound on angiogenesis. Ultrasound Med Biol. 1990;16(3):261-9. doi: 10.1016/0301-5629(90)90005-w. | |
| 27521134 | Background | Angulo JC, Arance I, de Las Heras MM, Meilan E, Esquinas C, Andres EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2017 Oct;41(8):479-490. doi: 10.1016/j.acuro.2016.07.005. Epub 2016 Aug 10. English, Spanish. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2021 | Aug 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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|
To evaluate for improvements in penile blood flow as detectable on penile Doppler and by measurement of intracavernosal pressures
| 12 months |
| Measurement of improvements in penile corporal tissues | To evaluate for improvements in penile blood flow as detectable by measurement of intracavernosal pressures | 12 months |
| 30120384 | Background | Sokolakis I, Dimitriadis F, Psalla D, Karakiulakis G, Kalyvianakis D, Hatzichristou D. Effects of low-intensity shock wave therapy (LiST) on the erectile tissue of naturally aged rats. Int J Impot Res. 2019 May;31(3):162-169. doi: 10.1038/s41443-018-0064-0. Epub 2018 Aug 17. |
| 30670837 | Background | Liu T, Shindel AW, Lin G, Lue TF. Cellular signaling pathways modulated by low-intensity extracorporeal shock wave therapy. Int J Impot Res. 2019 May;31(3):170-176. doi: 10.1038/s41443-019-0113-3. Epub 2019 Jan 22. |
| 28258952 | Background | Lin G, Reed-Maldonado AB, Wang B, Lee YC, Zhou J, Lu Z, Wang G, Banie L, Lue TF. In Situ Activation of Penile Progenitor Cells With Low-Intensity Extracorporeal Shockwave Therapy. J Sex Med. 2017 Apr;14(4):493-501. doi: 10.1016/j.jsxm.2017.02.004. Epub 2017 Mar 1. |
| 20451317 | Background | Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6. |
| 27986492 | Background | Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13. |
| 28962876 | Background | Man L, Li G. Low-intensity Extracorporeal Shock Wave Therapy for Erectile Dysfunction: A Systematic Review and Meta-analysis. Urology. 2018 Sep;119:97-103. doi: 10.1016/j.urology.2017.09.011. Epub 2017 Sep 27. |
| 41583708 | Derived | Coffey S, Nguyen V, Matthew AN, Kastelberg BS, Teves ME, Ghatas M, Klausner AP, Smith RP, Krzastek SC. Lack of sustained improvements in erectile function following low-intensity extracorporeal shockwave therapy correlate with decreases in corporal brain-derived neurotropic factor: a pilot study and prospective clinical trial. Sex Med. 2026 Jan 22;13(6):qfaf107. doi: 10.1093/sexmed/qfaf107. eCollection 2025 Dec. |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |