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Effectiveness and safety of combined autologous Platelet Rich Plasma and Focal Shockwave Therapy for the treatment of erectile dysfunction
EU CTIS ID: 2024-517248-73-00
What this study is testing
To evaluate the effectiveness of intracavernous 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 after 12 weeks of treatment completion.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Men over 18 years of age. 2. Erectile dysfunction present for more than 3 months in more than 50% of sexual intercourses. 3. Baseline IIEF-EF questionnaire score between 11 and 21. 4. Stable heterosexual relationship of at least 6 months. 5. Commitment to have at least 3 vaginal sexual relations per month after finishing treatment. 6. Commitment not to use other natural, oral or intracavernous pharmacological treatments during treatment and for up to 6 months after it has finished. 7. Patient who voluntarily agrees to enter the study by signing an informed consent.
You likely can't join if
- 1. Score of 4 on the EHS scale. 2. Patients with INR greater than 3. 3. Patients with sickle cell anemia. 4. Patients with clinical suspicion of hypogonadism (positive ADAM). 5. Acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency. 6. Active bladder, prostate, or colon cancer. 7. Radical prostatectomy or other radical pelvic surgery. 8. History of pelvic radiotherapy. 9. Spinal cord injury or other neurological disease associated with ED. 10. Penile anatomic dysfunction, penile implant. 11. Platelet diseases or coagulation disorders. 12. Treatment with oral anticoagulants. 13. Platelet count outside the normal range (150 to 400 × 109/L). 14. Patients with active infections or lesions of the penis or pubic area. 15. Patients with erectile dysfunction secondary to treatment with medications (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, antiparkinsonian drugs, antipsychotics). 16. Patients with erectile dysfunction of psychological origin. 17. Abuse of psychoactive substances (including alcohol). 18. Cognitive or physical illness that prevents the patient from participating in the study, from completing the questionnaires or attending therapies and controls. 19. Inability to attend therapies and controls.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.