Combined Treatment of Platelet-rich Plasma (PRP) and Low-intensity Extracorporeal Shockwave Therapy (Li-ESWT) on Erectile Dysfunction (ED)

Taipei Medical University

Status: Enrolling

Conditions: Erectile Dysfunction

Treatments: Combination Product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04416802

N201907013

Details and patient eligibility

About

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

Full description

According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent. At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction. Erectile dysfunction is the most common sexual dysfunction in men and is believed to be related to nerve or blood vessel damage, and often significantly affects the patients' quality of life.

PRP is the abbreviation of "platelet-rich plasma". It can release growth factors and cytokines in the body to further promote tissue repair. The results of pre-clinical and clinical trials show that PRP can promote the repair of cavernous tissue, protect erection function of nerve, and stimulate the regeneration of nerve.

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under this treatment, it will help body producing angiogenesis-related proteins, stimulating the formation of small blood vessels, generating new blood vessels at the site to be treated, and increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a significant effect on erectile dysfunction.

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

Enrollment: 20 estimated patients

Sex: Male

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Impotence for more than three months
• International index of erectile function, (IIEF) less than 21( including 21)
• Erectile hardness score, (EHS) less than 3( including 3)
• Age over 30 years old

Exclusion criteria

• Hypogonadism
• Bleeding tendency
• Could not cooperate with the treatment
• AIDS, syphilis and condyloma victim
• Received radical prostatectomy
• Prostate cancer or pelvis malignant tumor victim
• Gonad dysfunction
• Penis deformities
• Penile prosthesis implantation
• Psychiatric disease victim
• Neural disease ( multiple myeloma , brain atrophy, etc)
• Pacemaker implantation
• Not suitable join this trial judged by Investigator
• Alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PRP and Li-ESWT treatment

Experimental group

Description:

Participants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy.

Treatment:

Combination Product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy