Clinical trial NCT04416802: Combined Treatment of Platelet-rich Plasma (PRP) and Low-intensity Extracorporeal Shockwave Therapy (Li-ESWT) on Erectile Dysfunction (ED)
Official title: A Clinical Study of the Combined Treatment of Platelet-rich Plasma and Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Keywords: erectile dysfunction
platelet-rich plasma
low-intensity extracorporeal shockwave therapy
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Change in Erectile Function
timeFrame: Baseline, the 4th week, 8th week, and 12th weeks
measure: The Change in Erectile Function
timeFrame: Baseline, the 4th week, 8th week, and 12th weeks
Secondary outcomes:
measure: Incidents of Side Effects
timeFrame: the 4th week, 8th week, and 12th weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Ming-Che Liu, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.
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