Erectile DysfunctionNCT06433596
Autologous PRP and Focal Shock Waves for Erectile Dysfunction
A study testing Platelet-rich plasma and Shock waves therapy in people with Erectile Dysfunction, run by Elexial Research Limited at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Platelet-rich plasma and Shock waves therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 21.
- 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.
Who cannot join
- Score of 4 on the EHS scale.
- Patients with an international normalized ratio (INR) greater than 3.
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment
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:
Read more
- 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
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Platelet-rich plasma, Shock waves therapy, Placebo PRP, Sham shock waves therapy
- Keywords
- Erectile dysfunction, Platelet-rich plasma, Shock wave therapy, Randomized clinical trial
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaOther
Also called PRP
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Shock waves therapyOther
6 sessions of focal shock waves, 1 per week
Placebo PRPOther
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
Sham shock waves therapyOther
Also called Placebo therapy
6 sessions of sham shock waves, 1 per week
| Study group | Role | What they receive |
|---|---|---|
| Autologous PRP | Experimental | 3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves Receives: Other: Platelet-rich plasma; Other: Sham shock waves therapy |
| Combined therapy | Experimental | 3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves. Receives: Other: Platelet-rich plasma; Other: Shock waves therapy |
| Placebo control | Placebo comparator | 3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves Receives: Other: Placebo PRP; Other: Sham shock waves therapy |
| Shock waves | Active comparator | 3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock. Receives: Other: Shock waves therapy; Other: Placebo PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to the third month of follow-up at 21 weeks
Secondary outcomes (8)
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
Measured: From enrollment to the first month of follow-up at 13 weeks
Change in IIEF-EF score 6 months follow-up
Change in IIEF-EF score between baseline measurement and measurement at week 33
Measured: From enrollment to the sixth month of follow-up at 33 weeks
Minimum clinically significant difference
Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points)
Measured: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Change in Erection Hardness Score (EHS)
Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33
Measured: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
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.
Measured: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
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.
Measured: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Global assessment
Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33.
Measured: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Adverse events incidence
Incidence of PRP-related adverse events during the study
Measured: From the first intervention to end of follow-up at 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start6 May 2024
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elexial Research Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Group
- Responsible party
- Sponsor
- Investigators
- Jose Benitez, MD, Principal investigator, Boston Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433596
- Sponsor's protocol ID
- PRP-SW-03
- Other IDs
- 2022-002985-34
- Status last verified
- May 2026
- First submitted
- 23 May 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) collected throughout the trial, except personal identification data of the participants
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment
- ClinicalTrials.gov ID
- NCT06433596
- Acronym / sponsor ID
- PRP-SW-03
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Platelet-rich plasma, Shock wave therapy, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Elexial Research LimitedUniversity, hospital or other
- Collaborators
- Boston Medical Group
- Study start
- 6 May 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autologous PRP | Experimental | Other: Platelet-rich plasma, Other: Sham shock waves therapy3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves |
| Combined therapy | Experimental | Other: Platelet-rich plasma, Other: Shock waves therapy3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves. |
| Placebo control | Placebo comparator | Other: Placebo PRP, Other: Sham shock waves therapy3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves |
| Shock waves | Active comparator | Other: Shock waves therapy, Other: Placebo PRP3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 21.
- Stable heterosexual relationship of at least 6 months.
- Commitment to have at least 3 vaginal sexual relations per month after completing treatment.
Key exclusion criteria (19 listed)
- Score of 4 on the EHS scale.
- Patients with an international normalized ratio (INR) greater than 3.
- Patients with sickle cell anemia.
- Patients with clinical suspicion of hypogonadism (ADAM positive).
- Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich plasmaAlso: PRP3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9 | Other | Autologous PRP, Combined therapy |
| Shock waves therapy6 sessions of focal shock waves, 1 per week | Other | Combined therapy, Shock waves |
| Placebo PRP3 injections of 10 cc of saline solution, weeks 1, 5 and 9 | Other | Placebo control, Shock waves |
| Sham shock waves therapyAlso: Placebo therapy6 sessions of sham shock waves, 1 per week | Other | Autologous PRP, Placebo control |
Primary outcome
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)
8 secondary outcomes
Change in IIEF-EF score 1- month follow-up
Time frame: From enrollment to the first month of follow-up at 13 weeks
Change in IIEF-EF score 6 months follow-up
Time frame: From enrollment to the sixth month of follow-up at 33 weeks
Minimum clinically significant difference
Time frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Change in Erection Hardness Score (EHS)
Time frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Ability to penetrate
Time frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Quality of sexual life
Time frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Global assessment
Time frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Adverse events incidence
Time frame: From the first intervention to end of follow-up at 33 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) collected throughout the trial, except personal identification data of the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Benitez, MD principal investigator
Boston Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma and Shock waves therapy in people with Erectile Dysfunction, run by Elexial Research Limited at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IIEF-EF score (time frame: From enrollment to the third month of follow-up at 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.