NCT06433596

Autologous PRP and Focal Shock Waves for Erectile Dysfunction

Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Elexial Research Limited · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
OTHER	Platelet-rich plasma	3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
OTHER	Shock waves therapy	6 sessions of focal shock waves, 1 per week
OTHER	Placebo PRP	3 injections of 10 cc of saline solution, weeks 1, 5 and 9
OTHER	Sham shock waves therapy	6 sessions of sham shock waves, 1 per week

Timeline

• Start date: 2024-05-06
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-05-29
• Last updated: 2026-02-17

Locations

1 site across 1 country: Spain