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Trial History Detail on 2013-01-17

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

Unknown

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

No

2014-04-08

ChiCTR-TRC-11001652

2011-11-03


Yes

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