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

October 23, 2024 updated by: Hunter Holmes Mcguire Veteran Affairs Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
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.
Other Names:
  • Storz Duolith SD-1 t-top >>ultra<< device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Efficacy
Time Frame: 12 months
To evaluate the efficacy of the Storz Duolith SD-1 T-top >>ultra<< Li-ESWT device
12 months
Treatment Efficacy
Time Frame: 12 months
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
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of improvements in penile corporal tissues
Time Frame: 12 months
To evaluate for upregulation of nNOS, eNOS, BDNF and VEGF within penile corporal tissue
12 months
Measurement of improvements in penile corporal tissues
Time Frame: 12 months
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
Time Frame: 12 months
To evaluate for improvements in penile blood flow as detectable by measurement of intracavernosal pressures
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

September 21, 2023

Study Completion (Actual)

September 21, 2023

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1572819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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