PRP and focal waves for the treatment of erectile dysfunctio

Phase 1

• Conditions: Moderate or mild to moderate erectile dysfunction.; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2022-002985-34-ES
• Lead Sponsor: Boston Medical Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-23
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 87

Inclusion Criteria

1. Men over 18 years old.
2. Erectile dysfunction present for more than 3 months in more than 50% of coitus.
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 intercourse per month after treatment ends.
6.Commitment not to use other natural, oral or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
7.Patient who agrees to enter the study voluntarily by signing an informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 87
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 87

Exclusion Criteria

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 (ADAM positive).
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 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 (antiandrogenic therapy, Alpha blockers for BPH, use of corticosteroids, antiparkinsonians, 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-completing the questionnaires or attending therapies and controls.
19. Inability to attend therapies and controls.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified