NCT04416802

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: Male
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
COMBINATION_PRODUCT	autologous 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.

Timeline

• Start date: 2020-12-28
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2020-06-04
• Last updated: 2022-10-06

Locations

1 site across 1 country: Taiwan