Clinical trial NCT06433596: Autologous PRP and Focal Shock Waves for Erectile Dysfunction
Official title: Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Platelet-rich plasma
Shock wave therapy
Randomized clinical trial
Lead sponsor: Elexial Research Limited
Sponsor class: OTHER
Collaborators: name: Boston Medical Group
First posted: 2024-05-29
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in IIEF-EF score
timeFrame: From enrollment to the third month of follow-up at 21 weeks
Secondary outcomes:
measure: Change in IIEF-EF score 1- month follow-up
timeFrame: From enrollment to the first month of follow-up at 13 weeks
measure: Change in IIEF-EF score 6 months follow-up
timeFrame: From enrollment to the sixth month of follow-up at 33 weeks
measure: Minimum clinically significant difference
timeFrame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
measure: Change in Erection Hardness Score (EHS)
timeFrame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
measure: Ability to penetrate
timeFrame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
measure: Quality of sexual life
timeFrame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
measure: Global assessment
timeFrame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
measure: Adverse events incidence
timeFrame: From the first intervention to end of follow-up at 33 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Boston Medical Group Spain S.L.U
Study officials:
affiliation: Boston Medical Group
name: Jose Benitez, MD
role: PRINCIPAL_INVESTIGATOR
References: