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
Elexial Research Limited
116 participants
May 6, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria7
- Men over 18 years of age.
- Erectile dysfunction present for more than 3 months in more than 50% of intercourse.
- Baseline score of the IIEF-EF questionnaire between 11 and 21.
- Stable heterosexual relationship of at least 6 months.
- Commitment to have at least 3 vaginal sexual relations per month after completing treatment.
- Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
- A patient who agrees to voluntarily enter the study by signing an informed consent.
Exclusion Criteria19
- Score of 4 on the EHS scale.
- Patients with an international normalized ratio (INR) greater than 3.
- Patients with sickle cell anemia.
- Patients with clinical suspicion of hypogonadism (ADAM positive).
- Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency.
- Active bladder, prostate, or colon cancer.
- Radical prostatectomy or other radical pelvic surgery.
- History of pelvic radiotherapy.
- Spinal cord injury or other neurological disease associated with erectile dysfunction.
- Penile anatomical dysfunction, penile implant.
- Platelet diseases or coagulation disorders.
- Treatment with oral anticoagulants.
- Platelet count outside the normal range (150 to 400 × 109/L).
- Patients with active infections or lesions of the penis or pubic area.
- Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics).
- Patients with erectile dysfunction of psychological origin.
- Abuse of psychoactive substances (including alcohol).
- Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls.
- Inability to attend therapies and controls.
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Interventions
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
6 sessions of focal shock waves, 1 per week
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
6 sessions of sham shock waves, 1 per week
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06433596