New combo therapy aims to boost erections without drugs
NCT ID NCT06433596
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining platelet-rich plasma (PRP) injections with shock wave therapy can improve erections in men with moderate erectile dysfunction. 116 men will receive either the real treatment or a placebo over 9 weeks, then be followed for 6 months. The goal is to see if the combination is safe and effective for improving sexual function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men over 18 years of age. 2. Erectile dysfunction present for more than 3 months in more than 50% of intercourse. 3. Baseline score of the IIEF-EF questionnaire 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 completing treatment. 6. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion. 7. A patient who agrees to voluntarily enter the study by signing an informed consent. Exclusion Criteria: 1. Score of 4 on the EHS scale. 2. Patients with an international normalized ratio (INR) greater than 3. 3. Patients with sickle cell anemia. 4. Patients with clinical suspicion of hypogonadism (ADAM positive). 5. Acromegaly, gigantism, Addison 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 erectile dysfunction. 10. Penile anatomical 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 drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, 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 you from participating in the study, self-filling out the questionnaires, or attending therapies and controls. 19. Inability to attend therapies and controls.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Medical Group Spain S.L.U
Madrid, 28046, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can adding shockwaves to platelet therapy boost erectile function?
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- Can a Feather-Light penile monitor replace the uncomfortable gold standard?
- Can a Patient's own blood components outperform daily ED pills?