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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Study of the Combined Treatment of Platelet-rich Plasma and Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Combination Product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP and Li-ESWT treatment<br>Participants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy. | Combination Product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy<br>* The patient who encounters sexual dysfunction and visits our Outpatient Department (OPD) could enter this trial if he meets the inclusion criteria and exclusion criteria. To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment. Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment. Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS. Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment. Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS. Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Erectile Function | Using the International Index of Erectile Function (IIEF) questionnaire. | Baseline, the 4th week, 8th week, and 12th weeks | 
| The Change in Erectile Function | Using the Erectile Hardness Scale (EHS) questionnaire to evaluate the efficacy of combined treatment of PRP and Li-ESWT | Baseline, the 4th week, 8th week, and 12th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidents of Side Effects | To observe whether there are side effects | the 4th week, 8th week, and 12th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, platelet-rich plasma, low-intensity extracorporeal shockwave therapy