Status:
COMPLETED
Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction
Lead Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40-80 years
Phase:
NA
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 administrati...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04720755
Start Date
March 1 2021
End Date
September 21 2023
Last Update
October 26 2024
Active Locations (1)
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1
Hunter Holmes McGuire VAMC
Richmond, Virginia, United States, 23249