The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
University of Miami
Miami, Florida, United States
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Erection Hardness Score (EHS)
EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
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