Erectile dysfunction
Conditions
Interventions
2:Shockwave therapy for 9 weeks (12 sessions) vs Sham therapy(no enegry delivered) 9 weeks (12 sessions)
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects >=18 years old; 2. Patient with history of ED (defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) for more than 6 months; 3. Subject should be in a steady relationship with the same female partner (for more than 6 months); 4. Patient with with Sexual Health Inventory for Men (SHIM) score <=21; 5. Subjects with history of PDE 5-inhibitor use can be included in the study as long as they are willing to undergo a 2-week washout period. They could not use any other form of ED treatment for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with erectile dysfunction due to known endocrine disease (e.g. hypogonadism), drug treatment (androgen deprivation therapy, 5-alpha reductase inhibitors etc), neurological disease (such as spinal injury, pelvic surgery or trauma) or penile structural abnormality; 2. History of radical prostatectomy or other pelvic surgery; 3. History of pelvic irradiation; 4. History of penile implant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline for International Index of Erectile Function – Erectile function domain score (IIEF-EF) after one section of SWT at the 13-week; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes from baseline in the total International Index of Erectile Function (IIEF) score;IIEF-question 3 (frequency of penetration) (IIEF-Q3) and question 4 (frequency of maintained erections after penetration) (IIEF-Q4);Global Efficacy Question (GEQ);EHS after one section of SWT at the 13-week; | — |
Countries
China
Contacts
Public ContactNg Chi Fai
Outcome results
None listed