Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720755
• Other study ID #: 1572819
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 21, 2023

Study information

• Verified date: September 2023
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male veterans between 40 and 80 years of age
• Known or suspected vasculogenic erectile dysfunction based on clinical history
• In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment
• Suffering from ED for at least 6 months
• International Index of Erectile Function - EF domain score between 17-25, Erection Hardness Score score = 1
• Testosterone level between 300-1000ng/dL within one month prior to enrollment
• Hgb A1c = 8% within one month prior to enrollment
• Able to consent to study participation

Exclusion Criteria:

• Erectile dysfunction due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment.
• Men with known neurogenic or psychogenic ED
• Anatomic malformations of the penis including Peyronie's disease
• Testosterone < 300ng/dL or >1000ng/dL
• Hgb A1c > 8%
• International Normalized Ratio > 2.5, and men on any blood thinners other than 81mg aspirin 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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Low-Intensity Extracorporeal Shock Wave Therapy
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.

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VAMC	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Efficacy	To evaluate the efficacy of the Storz Duolith SD-1 T-top >>ultra<< Li-ESWT device	12 months
Primary	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
Primary	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
Secondary	Measurement of improvements in penile corporal tissues	To evaluate for upregulation of nNOS, eNOS, BDNF and VEGF within penile corporal tissue	12 months
Secondary	Measurement of improvements in penile corporal tissues	To evaluate for improvements in penile blood flow as detectable on penile Doppler and by measurement of intracavernosal pressures	12 months
Secondary	Measurement of improvements in penile corporal tissues	To evaluate for improvements in penile blood flow as detectable by measurement of intracavernosal pressures	12 months