Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00263

2 Trial Registration Date

2010-04-07

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Olympus Medical Systems Corporation

5 Primary Sponsor

Division of Urology, Department of Surgery, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Dr. Chan Ning Hong

ii Address

4/F, Clinical Sciences Building, Princes of Wales Hospital, Shatin, N.T. Hong Kong

iii Phone

2632 2625

iv Email

nhchan@surgery.cuhk.edu.hk

v Affiliation

Professor, Department of Surgery

vi Country

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

i Name

Dr. Chan Ning Hong

ii Address

4/F, Clinical Sciences Building, Princes of Wales Hospital, Shatin, N.T. Hong Kong

iii Phone

2632 2625

iv Email

nhchan@surgery.cuhk.edu.hk

v Affiliation

Professor, Department of Surgery

vi Country

9 Official Scientific Title of the Study

A Prospective Randomized Controlled Trial comparing efficacy of Hybrid Bipolar transurethral vaporization and resection of prostate with Bipolar transurethral resection of prostate

10 Public Title

A Prospective Randomized Controlled Trial comparing efficacy of Hybrid Bipolar transurethral vaporization and resection of prostate with Bipolar transurethral resection of prostate

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

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?

2010-02-25

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Benign Prostatic Hyperplasia

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Hybrid Bipolar transurethral vaporization and resection of prostate (hybrid bipolar TURP)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 day

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Bipolar resection of prostate (bipolar TURP)

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

• Benign prostatic hyperplasia aged 50 or above and fit for anaesthesia, AND
• One of the following:
 Failed medical therapy with alpha-blockers or 5-alpha reductase inhibitors, with International Prostate Symptoms Score (IPSS) ≥ 18 and maximal flow rate (Qmax) ≤ 15ml/s, OR Recurrent urinary retention

ii Exclusion Criteria

Previous history of TURP or other forms of intervention for benign prostate hyperplasia
Patient confirmed to have carcinoma of prostate
Patients with neurogenic bladder, bladder stone, diverticula or urethral stricture

iii Age Minimum

50

iv Age Maximum

NA

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2010-04-10

21 Target Sample Size

146

22 Recruitment Status

Complete

23 Primary Outcome

catheter time

24 Secondary Outcome

hospital stay, and post operative dysuria scores.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-12-18

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10000852

28 Date of Registration in Primary Registry

2010-10-15

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-12-18