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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Intensity Extracorporeal Shock Wave Therapy
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Low intensity shock wave therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hunter Holmes McGuire VAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measurement of improvements in penile corporal tissues
To evaluate for upregulation of nNOS, eNOS, BDNF and VEGF within penile corporal tissue
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
Measurement of improvements in penile corporal tissues
To evaluate for improvements in penile blood flow as detectable by measurement of intracavernosal pressures

Full Information

First Posted
December 15, 2020
Last Updated
September 21, 2023
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04720755
Brief Title
Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction
Official Title
Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 21, 2023 (Actual)
Study Completion Date
September 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, Low intensity shock wave therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Low-Intensity Extracorporeal Shock Wave Therapy
Other Intervention Name(s)
Storz Duolith SD-1 t-top >>ultra<< device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Efficacy
Description
To evaluate the efficacy of the Storz Duolith SD-1 T-top >>ultra<< Li-ESWT device
Time Frame
12 months
Title
Treatment Efficacy
Description
To provide data in support of a standardized protocol for the treatment duration for use of this device in treatment of erectile dysfuntion
Time Frame
12 months
Title
Treatment Efficacy
Description
To provide data in support of a standardized protocol for the treatment dose for use of this device in treatment of erectile dysfuntion
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measurement of improvements in penile corporal tissues
Description
To evaluate for upregulation of nNOS, eNOS, BDNF and VEGF within penile corporal tissue
Time Frame
12 months
Title
Measurement of improvements in penile corporal tissues
Description
To evaluate for improvements in penile blood flow as detectable on penile Doppler and by measurement of intracavernosal pressures
Time Frame
12 months
Title
Measurement of improvements in penile corporal tissues
Description
To evaluate for improvements in penile blood flow as detectable by measurement of intracavernosal pressures
Time Frame
12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants must be men with erectile disfunction.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hunter Holmes McGuire VAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1694604
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.
Results Reference
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PubMed Identifier
27521134
Citation
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.
Results Reference
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PubMed Identifier
30120384
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.
Results Reference
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PubMed Identifier
30670837
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.
Results Reference
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PubMed Identifier
28258952
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.
Results Reference
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PubMed Identifier
20451317
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.
Results Reference
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PubMed Identifier
27986492
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction

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