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The goal of this clinical trial is to learn if Platelet-rich plasma (PRP) combined with Shock-wave therapy (SWT) works to treat moderate or mild to moderate erectile dysfunction. It will also learn about the safety of this combined therapy.
The main questions it aims to answer are:
Researchers will compare Combined therapy PRP + SWT to placebo therapy (a look-alike substance that contains no PRP) to see if Combined therapy PRP + SWT works to treat moderate or mild to moderate erectile dysfunction.
Participants will:
Full description
The goal of this clinical trial is to evaluate the effectiveness of intracavernosal autologous platelet-rich plasma therapy, compared with placebo, for the treatment of moderate or mild to moderate erectile dysfunction, measured as improvement in the IIEF-EF questionnaire score.
Study design: Randomized, double-blind, placebo-controlled clinical trial, phase III. The study will include four groups:
G1 - Autologous PRP: Autologous Platelet Rich Plasma (PRP) + placebo shock waves
G2 - combined therapy: Autologous PRP + focal shock waves
G3 - placebo control: Placebo PRP + placebo shock waves
G4 - shock waves: PRP placebo + shock waves
116 subjects will be included, who will be randomized in a 1:1:1:1 ratio in the four groups described above.
The change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) score, the change in the Erection Hardness Score (EHS), and the adverse events will be evaluated at the end of treatment, and 1, 3, and 6 months of follow-up.
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116 participants in 4 patient groups, including a placebo group
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Central trial contact
Héctor Corredor, MD; Carolina Sandoval, Master
Data sourced from clinicaltrials.gov
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