CUHK_CCT00299
2011-10-04
Prospective
Nil
Departmental research funding, Division of Urology, Department of Surgery, CUHK
The Chinese University of Hong Kong
Nil
Ng Chi Fai
4/F., Department of Surgery, CSB, PWH, H.K.
26322625
ngcf@surgery.cuhk.edu.hk
The Chinese University of Hong Kong
Ng Chi Fai
4/F., Department of Surgery, CSB, PWH, H.K.
26322625
ngcf@surgery.cuhk.edu.hk
The Chinese University of Hong Kong
A prospective randomized double-blinded placebo controlled study on the effects of shockwave therapy in patients suffered erectile dysfunction
Shockwave therapy for erectile dysfunction
Shockwave therapy for erectile dysfunction
Hong Kong
Yes
2011-09-12
Erectile dysfunction
Procedure
Shockwave therapy
9 weeks (12 sessions)
Sham therapy(no enegry delivered) 9 weeks (12 sessions)
- Subjects ≥ 18 years old,
- 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,
- Subject should be in a steady relationship with the same female partner (for more than 6 months),
- Patient with with Sexual Health Inventory for Men (SHIM) score ≤ 21,
- 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.
- 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,
- History of radical prostatectomy or other pelvic surgery,
- History of pelvic irradiation,
- History of penile implant
18
NA
Male
Interventional
Randomized
Placebo
Double-blind
Parallel
2011-10-17
70
Complete
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
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
2014-04-08
ChiCTR-TRC-11001652
2011-11-03
Yes
Nil
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