Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00311

2 Trial Registration Date

2012-01-04

i Registration Status

Prospective

3 Secondary IDs

NIL

4 Source(s) of Funding

Health and Health Services Research Fund

5 Primary Sponsor

Urology Division, Department of Surgery, CUHK

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Prof. Ng, Chi Fai

ii Address

4/F., Department of Surgery, Clinical Science Building, PWH

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

Urology Division, Department of Surgery, CUHK

vi Country

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

i Name

Prof. Ng, Chi Fai

ii Address

4/F., Department of Surgery, Clinical Science Building, PWH

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

Urology Division, Department of Surgery, CUHK

vi Country

9 Official Scientific Title of the Study

The role of weight reduction on the severity of lower urinary tract symptoms in obese male patients with benign prostatic hyperplasia

10 Public Title

The role of weight reduction on the severity of lower urinary tract symptoms in obese male patients with benign prostatic hyperplasia

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?

2011-01-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Benign prostatic hyperphasia

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Weight reduction program supervised by physician, dietitian and physiotherapist

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

48 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Weight reduction advice, 48 weeks of follow up

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

 Male patient with aged ≥ 50 years old
 Defined as obese, with BMI > 25 Kg/m2
 With moderate to severe lower urinary tract symptom (IPSS > 7)
 Maximum flow rate between 5 – 15 ml / s
 Post-void residual urine < 150 ml
 Prostate volume as measured by transrectal ultrasound > 30 cc

ii Exclusion Criteria

 Patients considered as extreme obese, with BMI >35 Kg/m2
 Patients with LUTS due to urethral stricture, neurogenic bladder or other structural abnormality
 Patients with long-term catheterization or who perform intermittent self-catheterization
 Patients with known history of prostate cancer or bladder cancer at the time of assessment
 Patients with on 5α-reductase inhibitors, phytotherapy, or other hormonal therapy
 Patients with history of prostatic / bladder surgery or other pelvic surgery that may affect voiding
 Patients with bladder stones or an active urinary tract infection at the time of assessment
 Patient do not tolerate tamsulosin OCAS for the management of LUTS
 Patient with poor cardiac status (NYHA class III or above) or other medical conditions that are not suitable for intense exercise or weight reduction programme

iii Age Minimum

50

iv Age Maximum

NIL

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Open label

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

2012-01-15

21 Target Sample Size

130

22 Recruitment Status

Recruiting

23 Primary Outcome

Change in total score of International Prostate Symptom Score (IPSS) at the end of trial (52 weeks), when compared to the baseline IPSS

24 Secondary Outcome

Change in the maximum flow rate (Qmax), total irritative symptom score of IPSS (Q2, 4 & 7), number of nocturia, Qol score, PSA level and prostate volume at the end of 52 weeks, when compared to baseline

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12001978

28 Date of Registration in Primary Registry

2012-03-02

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NIL

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Trial History Detail on 2013-01-08