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Erectile DysfunctionNCT04720755

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

A study testing Low-Intensity Extracorporeal Shock Wave Therapy in people with Erectile Dysfunction, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 80 years, men onlyHealthy volunteers can take part
Conditions the study is for
Erectile Dysfunction
What is being tested?
Low-Intensity Extracorporeal Shock Wave Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
1 Mar 2021to 21 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hunter Holmes McGuire VAMC

    Richmond, Virginia, 23249

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
Low-Intensity Extracorporeal Shock Wave Therapy
Keywords
Erectile Dysfunction, Low intensity shock wave therapy
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-Intensity Extracorporeal Shock Wave TherapyDevice

    Also called Storz Duolith SD-1 t-top >>ultra<< 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.

Study groups in NCT04720755
Study groupRoleWhat they receive
TreatmentExperimentalParticipants 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)
Receives: Device: Low-Intensity Extracorporeal Shock Wave Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Efficacy

    To evaluate the efficacy of the Storz Duolith SD-1 T-top >>ultra<< Li-ESWT device

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. 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

    Measured: 12 months

Secondary outcomes (3)

  1. Measurement of improvements in penile corporal tissues

    To evaluate for upregulation of nNOS, eNOS, BDNF and VEGF within penile corporal tissue

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. Measurement of improvements in penile corporal tissues

    To evaluate for improvements in penile blood flow as detectable by measurement of intracavernosal pressures

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start1 Mar 2021
  3. Primary completion21 Sep 2023
  4. Study completion21 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04720755
Sponsor's protocol ID
1572819
Status last verified
Oct 2024
First submitted
15 Dec 2020
Last updated
26 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 1694604

  • 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.

    PubMed 27521134

  • 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.

    PubMed 30120384

  • 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.

    PubMed 30670837

  • 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.

    PubMed 28258952

  • 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.

    PubMed 20451317

  • 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.

    PubMed 27986492

  • 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.

    PubMed 28962876

  • 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.

    PubMed 41583708

Questions about this trial

What is this clinical trial studying?

A study testing Low-Intensity Extracorporeal Shock Wave Therapy in people with Erectile Dysfunction, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Efficacy (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04720755, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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