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Autologous PRP and Focal Shock Waves for Erectile Dysfunction
Sponsor: Elexial Research Limited
Summary
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: * Does Combined therapy PRP + SWT improve erection in men with moderate or mild to moderate erectile dysfunction? * What medical problems do participants have when receiving Combined therapy PRP + SWT? 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: * Take a lab test to evaluate their platelets * Answer some questionnaires to assess your erectile function * Receive Combined therapy PRP + SWT (3 sessions PRP + 6 sessions SWT) or placebo therapy for 9 weeks * Visit the clinic one month, 3 months, and 6 months after finishing the treatment for checkups and tests
Official title: Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2024-05-06
Completion Date
2026-12
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Shock waves therapy
6 sessions of focal shock waves, 1 per week
Placebo PRP
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
Sham shock waves therapy
6 sessions of sham shock waves, 1 per week
Locations (1)
Boston Medical Group Spain S.L.U
Madrid, Madrid, Spain