Autologous PRP and Focal Shock Waves for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06433596
• Other study ID #: PRP-SW-03
• Secondary ID: 2022-002985-34
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Elexial Research Limited
• Contact: Carolina Sandoval, Master
• Phone: 0057 31339208916
• Email: csandoval[@]bostonmedical.com.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
• Shock waves therapy
6 sessions of focal shock waves, 1 per week
• Placebo PRP
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
• Sham shock waves therapy
6 sessions of sham shock waves, 1 per week

Locations

Country	Name	City	State
Spain	Boston Medical Group Spain S.L.U	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Elexial Research Limited	Boston Medical Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IIEF-EF score	Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline and week 21 (3 months after completion of treatment)	From enrollment to the third month of follow-up at 21 weeks
Secondary	Change in IIEF-EF score 1- month follow-up	Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline measurement and measurement at week 13	From enrollment to the first month of follow-up at 13 weeks
Secondary	Change in IIEF-EF score 6 months follow-up	Change in IIEF-EF score between baseline measurement and measurement at week 33	From enrollment to the sixth month of follow-up at 33 weeks
Secondary	Minimum clinically significant difference	Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points)	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary	Change in Erection Hardness Score (EHS)	Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary	Ability to penetrate	Proportion of patients who accomplish to penetrate after treatment, evaluated by the change in the EHS from 1 or 2 at baseline to 3 or 4 in weeks 13, 21 and 33.	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary	Quality of sexual life	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.	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary	Global assessment	Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33.	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary	Adverse events incidence	Incidence of PRP-related adverse events during the study	From the first intervention to end of follow-up at 33 weeks