A study on the efficacy and safety of ED1000 in post-prostatectomy patients

JRCT ID: jRCTs062230072

Registered date:09/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 09/11/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Low-intensity external shock wave therapy to the penis of post-radical prostatectomy patients

Outcome(s)

• Primary Outcome: Improvement of sexual function by IIEF score

Secondary Outcome

Evaluation of safety for ED1000 treatment
Post-treatment quality of life (QOL) survey

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Male

Include criteria

1) Patients scheduled for RARP at the Department of Urology, Hiroshima University Hospital
2) Patients aged 40 to 80 years at the time of informed consent
3)Patients whose degree of sexual desire is higher than her normal (3 points) on the health-related QOL questionnaire (EPIC) before surgery
4) Patients who have given written informed consent to participate in this study

Exclude criteria

1) Patients with spinal cord injuries, chronic blood disorders, and anatomical abnormalities of penile blood vessels
2) Patients with endocrine disorders, psychiatric disorders or psychological abnormalities that cause ED
3) Ischemic heart disease attack, cerebral hemorrhage, cerebral infarction, fatal arrhythmia within the past 6 months, and taking drugs such as aspirin and warfarin, which are listed as bleeding risks at Hiroshima University Hospital Patients who cannot stop taking the drug for a certain period of time
4) Patients with cardiovascular disorders who are prohibited from sexual activity (acute coronary syndrome within 3 months after onset, heart disease that is difficult to control (1) acute coronary syndrome within 3 months after onset, 2) heart failure (NYHA III or higher), (3) Intractable arrhythmia), severe renal impairment (eGFR<30ml/min/1.73m2))
5) Patients with sexually transmitted diseases, infections such as local abscesses in the penis, and penile injuries
6) Patients taking nitrates such as nitroglycerin
7) Patients with pacemaker or defibrillator implants
8) Patients who are judged to be inappropriate by the principal investigator/subinvestigator

Related Information

• Primary Sponsor: Hinata Nobuyuki