Prostate cancer Prostate cancer
Conditions
Interventions
Low-intensity external shock wave therapy to the penis of post-radical prostatectomy patients
ED1000
Sponsors
Hinata Nobuyuki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of sexual function by IIEF score | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety for ED1000 treatment Post-treatment quality of life (QOL) survey | — |
Contacts
Public ContactKeisuke Goto
Hiroshima University Hospital
Outcome results
None listed