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

NCT04720755 | Completed

• 1 other identifier: 1572819
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Low intensity shock wave therapy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Measurement of improvements in penile corporal tissues

  12 months

• Measurement of improvements in penile corporal tissues

  12 months

• Measurement of improvements in penile corporal tissues

  12 months

Study Arms (1)

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)

Device: Low-Intensity Extracorporeal Shock Wave Therapy

Interventions

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.

Also known as: Storz Duolith SD-1 t-top >>ultra<< device

Treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Participants must be men with erectile disfunction.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead

Study Sites (1)

Hunter Holmes McGuire VAMC

Richmond, Virginia, 23249, United States

Location

Related Publications (9)

• 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.

  PMID: 1694604 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.

  PMID: 27521134 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.

  PMID: 30120384 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.

  PMID: 30670837 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.

  PMID: 28258952 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.

  PMID: 20451317 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.

  PMID: 27986492 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.

  PMID: 28962876 BACKGROUND

• 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.

  PMID: 41583708 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 22, 2021
• Study Start: March 1, 2021
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)