Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00299

2 Trial Registration Date

2011-10-04

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Departmental research funding, Division of Urology, Department of Surgery, CUHK

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ng Chi Fai

ii Address

4/F., Department of Surgery, CSB, PWH, H.K.

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ng Chi Fai

ii Address

4/F., Department of Surgery, CSB, PWH, H.K.

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A prospective randomized double-blinded placebo controlled study on the effects of shockwave therapy in patients suffered erectile dysfunction

10 Public Title

Shockwave therapy for erectile dysfunction

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Shockwave therapy for erectile dysfunction

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-09-12

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Erectile dysfunction

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Shockwave therapy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

9 weeks (12 sessions)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Sham therapy(no enegry delivered) 9 weeks (12 sessions)

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

- 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.

ii Exclusion Criteria

- 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

iii Age Minimum

18

iv Age Maximum

NA

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-10-17

21 Target Sample Size

70

22 Recruitment Status

Unknown

23 Primary Outcome

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

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-04-08

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001652

28 Date of Registration in Primary Registry

2011-11-03

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-01-17