Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Elexial Research Limited
- Enrollment
- 116
- Locations
- 2
- Primary Endpoint
- Change in IIEF-EF score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men over 18 years of age.
- •Erectile dysfunction present for more than 3 months in more than 50% of intercourse.
- •Baseline score of the IIEF-EF questionnaire between 11 and
- •Stable heterosexual relationship of at least 6 months.
- •Commitment to have at least 3 vaginal sexual relations per month after completing treatment.
- •Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
- •A patient who agrees to voluntarily enter the study by signing an informed consent.
Exclusion Criteria
- •Score of 4 on the EHS scale.
- •Patients with an international normalized ratio (INR) greater than
- •Patients with sickle cell anemia.
- •Patients with clinical suspicion of hypogonadism (ADAM positive).
- •Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency.
- •Active bladder, prostate, or colon cancer.
- •Radical prostatectomy or other radical pelvic surgery.
- •History of pelvic radiotherapy.
- •Spinal cord injury or other neurological disease associated with erectile dysfunction.
- •Penile anatomical dysfunction, penile implant.
- •Platelet diseases or coagulation disorders.
- •Treatment with oral anticoagulants.
- •Platelet count outside the normal range (150 to 400 × 109/L).
- •Patients with active infections or lesions of the penis or pubic area.
- •Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics).
- •Patients with erectile dysfunction of psychological origin.
- •Abuse of psychoactive substances (including alcohol).
- •Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls.
- •Inability to attend therapies and controls.
Arms & Interventions
Autologous PRP
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
Intervention: Sham shock waves therapy (Other)
Combined therapy
3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
Intervention: Shock waves therapy (Other)
Autologous PRP
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
Intervention: Platelet-rich plasma (Other)
Placebo control
3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
Intervention: Placebo PRP (Other)
Placebo control
3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
Intervention: Sham shock waves therapy (Other)
Shock waves
3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.
Intervention: Shock waves therapy (Other)
Shock waves
3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.
Intervention: Placebo PRP (Other)
Combined therapy
3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
Intervention: Platelet-rich plasma (Other)
Outcomes
Primary Outcomes
Change in IIEF-EF score
Time Frame: 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 Outcomes
- Minimum clinically significant difference(From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks)
- Change in IIEF-EF score 1- month follow-up(From enrollment to the first month of follow-up at 13 weeks)
- 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 IIEF-EF score 6 months follow-up(From enrollment to the sixth month of follow-up at 33 weeks)
- Global assessment(From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks)
- Adverse events incidence(From the first intervention to end of follow-up at 33 weeks)
- Ability to penetrate(From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks)
- Quality of sexual life(From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks)