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Trial History Detail on 2015-05-10

CUHK_CCT00311

2012-01-04

Prospective

NIL

Health and Health Services Research Fund

Urology Division, Department of Surgery, CUHK

NA

Prof. Ng, Chi Fai

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

26322625

ngcf@surgery.cuhk.edu.hk

Urology Division, Department of Surgery, CUHK

Prof. Ng, Chi Fai

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

26322625

ngcf@surgery.cuhk.edu.hk

Urology Division, Department of Surgery, CUHK

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

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

NIL

Hong Kong

Yes

2011-01-03

Benign prostatic hyperphasia

Behavior

Weight reduction program supervised by physician, dietitian and physiotherapist

48 weeks

Weight reduction advice, 48 weeks of follow up

 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

 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

50

NIL

Male

Interventional

Randomized

Dose comparison

Open label

Parallel

2012-01-15

130

Unknown

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

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

No

2015-07-06

ChiCTR-TRC-12001978

2012-03-02


Yes

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