Erectile Dysfunction
Conditions
Keywords
erectile dysfunction, platelet-rich plasma, low-intensity extracorporeal shockwave therapy
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.
Interventions
COMBINATION_PRODUCTautologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy
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. 1. To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment. 2. Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment. 3. Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS. 4. Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment. 5. Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS. 6. Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
Sponsors
Taipei Medical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Erectile Function | Baseline, the 4th week, 8th week, and 12th weeks | Using the International Index of Erectile Function (IIEF) questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidents of Side Effects | the 4th week, 8th week, and 12th weeks | To observe whether there are side effects |
Countries
Taiwan
Contacts
Primary ContactMing-Che Liu, MD
Backup ContactYi-Jen Su
Outcome results
None listed