## Protocol Section
### Identification Module
**NCT ID:** NCT06433596

**Brief Title:** 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

#### Organization Study ID Info
**ID:** PRP-SW-03
#### Organization
**Class:** OTHER
**Full Name:** Elexial Research Limited
#### Secondary ID Infos
**ID:** 2022-002985-34
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Boston Medical Group

#### Lead Sponsor

**Class:** OTHER

**Name:** Elexial Research Limited

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Erectile Dysfunction

**Keywords:**

- Erectile dysfunction

- Platelet-rich plasma

- Shock wave therapy

- Randomized clinical trial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 116

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves

**Intervention Names:**

- Other: Platelet-rich plasma

- Other: Sham shock waves therapy

**Label:** Autologous PRP

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.

**Intervention Names:**

- Other: Platelet-rich plasma

- Other: Shock waves therapy

**Label:** Combined therapy

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves

**Intervention Names:**

- Other: Placebo PRP

- Other: Sham shock waves therapy

**Label:** Placebo control

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** 3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.

**Intervention Names:**

- Other: Shock waves therapy

- Other: Placebo PRP

**Label:** Shock waves

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Autologous PRP

- Combined therapy

**Description:** 3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9

**Name:** Platelet-rich plasma

**Other Names:**

- PRP

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Combined therapy

- Shock waves

**Description:** 6 sessions of focal shock waves, 1 per week

**Name:** Shock waves therapy

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Placebo control

- Shock waves

**Description:** 3 injections of 10 cc of saline solution, weeks 1, 5 and 9

**Name:** Placebo PRP

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Autologous PRP

- Placebo control

**Description:** 6 sessions of sham shock waves, 1 per week

**Name:** Sham shock waves therapy

**Other Names:**

- Placebo therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline and week 21 (3 months after completion of treatment)

**Measure:** Change in IIEF-EF score

**Time Frame:** From enrollment to the third month of follow-up at 21 weeks

#### Secondary Outcomes

**Description:** Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline measurement and measurement at week 13

**Measure:** Change in IIEF-EF score 1- month follow-up

**Time Frame:** From enrollment to the first month of follow-up at 13 weeks

**Description:** Change in IIEF-EF score between baseline measurement and measurement at week 33

**Measure:** Change in IIEF-EF score 6 months follow-up

**Time Frame:** From enrollment to the sixth month of follow-up at 33 weeks

**Description:** Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points)

**Measure:** Minimum clinically significant difference

**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks

**Description:** Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33

**Measure:** 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

**Description:** 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.

**Measure:** Ability to penetrate

**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks

**Description:** 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.

**Measure:** Quality of sexual life

**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks

**Description:** Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33.

**Measure:** Global assessment

**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks

**Description:** Incidence of PRP-related adverse events during the study

**Measure:** Adverse events incidence

**Time Frame:** From the first intervention to end of follow-up at 33 weeks

### Eligibility Module

**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.

**Gender Based:** True

**Gender Description:** The participant must be male by biological sex and their gender identity must be male

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** csandoval@bostonmedical.com.co

**Name:** Carolina Sandoval, Master

**Phone:** 0057 31339208916

**Role:** CONTACT

**Contact 2:**

**Email:** hcorredor@bostonmedical.com.co

**Name:** Héctor Corredor, MD

**Phone:** 0057 3174317162

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Email:** jbenitez@boston.es

- **Name:** Jose Benitez, MD

- **Phone:** 0034 607769225

- **Role:** CONTACT

***Contact 2:***

- **Email:** mrodriguez@boston.es

- **Name:** Mercedes Rodriguez, Coordinator

- **Phone:** 0034 610238191

- **Role:** CONTACT

***Contact 3:***

- **Name:** Jose Aramis Benitez, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Boston Medical Group Spain S.L.U

**Status:** RECRUITING

**Zip:** 28046

#### Overall Officials

**Official 1:**

**Affiliation:** Boston Medical Group

**Name:** Jose Benitez, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** All individual participant data (IPD) collected throughout the trial, except personal identification data of the participants

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** Beginning 1 month after publication with no end date

**URL:** https://www.elexialresearch.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000012735

- Term: Sexual Dysfunction, Physiological

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000020018

- Term: Sexual Dysfunctions, Psychological

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: LOW

- As Found: Unknown

- ID: M10217

- Name: Erectile Dysfunction

- Relevance: HIGH

- As Found: Erectile Dysfunction

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15546

- Name: Sexual Dysfunction, Physiological

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21873

- Name: Sexual Dysfunctions, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007172

- Term: Erectile Dysfunction

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
