Moderate or mild to moderate erectile dysfunction.
Conditions
Interventions
Product Name: PRP - RegenKit®-BCT-3 Plus
Product Code: -
Pharmaceutical Form: Injection
INN or Proposed INN: PRP - RegenKit®-BCT-3 Plus
Other descriptive name: Autologous platelet rich plasma and bloo
Sponsors
Boston Medical Group
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess 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 IIEF-EF questionnaire score after 12 weeks from the end of the treatment.;Secondary Objective: To assess the effectiveness of intracavernous autologous platelet-rich plasma therapy for the treatment of moderate or mild to moderate erectile dysfunction, at 4, 12 and 24 weeks after the end of treatment (1 and 6 months of follow-up). To assess the effectiveness of intracavernous autologous platelet-rich plasma therapy combined with focal shock wave therapy, for the treatment of moderate or mild to moderate erectile dysfunction, at 4, 12 and 24 weeks after the end of treatment (1, 3 and 6 month follow-up). To assess the clinical safety of intracavernous autologous platelet-rich plasma therapy, alone and in combination with shock wave therapy, for the treatment of moderate or mild to moderate erectile dysfunction.;Primary end point(s): Change in IIEF-EF score between the baseline measurement and the measurement at week 21 (3 months after the end of treatment).;Timepoint(s) of evaluation of this end point: week 21 (3 months after the end of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in IIEF-EF score between baseline measurement and measurement at week 13 (1-month follow-up) - Change in IIEF-EF score between baseline measurement and measurement at week 33 (6-month follow-up) - Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points), at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up). - Change in EHS score between the baseline measurement and the measurement at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up). - Proportion of patients who achieve penetration after treatment, evaluated by the change in EHS from 1 or 2 at baseline to 3 or 4 at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up). - Change in the score of the sexual quality of life questionnaire - SLQQ between the baseline measurement and the measurement at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up). - Change in global assessment questionnaire score - CGA at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up). - Incidence of adverse events related to PRP during the study.;Timepoint(s) of evaluation of this end point: - week 13 (1-month follow-up) - week 33 (6-month follow-up) - weeks 13, 21 and 33 (1, 3 and 6 months of follow-up) - weeks 13, 21 and 33 (1, 3 and 6 months of follow-up) - weeks 13, 21 and 33 (1, 3 and 6 months of follow-up) - weeks 13, 21 and 33 (1, 3 and 6 months of follow-up) - weeks 13, 21 and 33 (1, 3 and 6 months of follow-up) | — |
Countries
Spain
Contacts
Public ContactJosé Benitez Molina
Boston Medical Group
Outcome results
None listed