Autologous PRP and Focal Shock Waves for Erectile Dysfunction

Elexial Research Limited

Status: Enrolling

Conditions: Erectile Dysfunction

Treatments: Other: Placebo PRP; Other: Shock waves therapy; Other: Sham shock waves therapy; Other: Platelet-rich plasma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06433596

2022-002985-34 (EudraCT Number)

PRP-SW-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 4 patient groups, including a placebo group

Autologous PRP

Experimental group

Description:

3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves

Treatment:

Other: Platelet-rich plasma

Other: Sham shock waves therapy

Combined therapy

Experimental group

Description:

3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.

Treatment:

Other: Platelet-rich plasma

Other: Shock waves therapy

Placebo control

Placebo Comparator group

Description:

3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves

Treatment:

Other: Sham shock waves therapy

Other: Placebo PRP

Shock waves

Active Comparator group

Description:

3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.

Treatment:

Other: Shock waves therapy

Other: Placebo PRP