Autologous PRP and Focal Shock Waves for Erectile Dysfunction

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction
• Interventions: Other: Platelet-rich plasma; Other: Placebo PRP; Other: Shock waves therapy; Other: Sham shock waves therapy

• Registration Number: NCT06433596
• Lead Sponsor: Elexial Research Limited

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-06
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-29
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined therapy	Shock waves therapy	3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
Autologous PRP	Sham shock waves therapy	3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
Autologous PRP	Platelet-rich plasma	3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
Combined therapy	Platelet-rich plasma	3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
Placebo control	Sham shock waves therapy	3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
Shock waves	Shock waves therapy	3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.
Placebo control	Placebo PRP	3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
Shock waves	Placebo PRP	3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.

Primary Outcome Measures

Name	Time	Method
Change in IIEF-EF score	From enrollment to the third month of follow-up at 21 weeks	Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline and week 21 (3 months after completion of treatment)

Secondary Outcome Measures

Name	Time	Method
Minimum clinically significant difference	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks	Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points)
Change in IIEF-EF score 1- month follow-up	From enrollment to the first month of follow-up at 13 weeks	Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline measurement and measurement at week 13
Change in Erection Hardness Score (EHS)	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks	Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33
Adverse events incidence	From the first intervention to end of follow-up at 33 weeks	Incidence of PRP-related adverse events during the study
Ability to penetrate	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks	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.
Quality of sexual life	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks	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.
Change in IIEF-EF score 6 months follow-up	From enrollment to the sixth month of follow-up at 33 weeks	Change in IIEF-EF score between baseline measurement and measurement at week 33
Global assessment	From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks	Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33.

Trial Locations

Locations (1)

Boston Medical Group Spain S.L.U; 🇪🇸 Madrid, Spain