Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT00861588

Collaborator

School of Pharmacy, CUHK (Other)

176

Enrollment

Location

Arms

Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that produces significant morbidity and hea1th care costs. It is likely that BPH is just as common among Chinese men. Debate exists as to whether currently available surgical and pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this condition. Evidence suggests that the consumption of soy isoflavones is related to lower rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies may include better patient compliance, improved safety and lower cost. Despite the fact that soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism of action, no randomised control trial has been performed using isoflavones to treat BPH. Therefore, a randomised control trial is proposed to test the tolerability and effectiveness of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will be reviewed every three months with maximal urine flow rate, international prostate symptoms score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize that this intervention will reduce lower urinary tract symptoms and slow the progression of the disease.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostate Hyperplasia	Drug: isoflavones (Soylife 25) Drug: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: isoflavones Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive isoflavones	Drug: isoflavones (Soylife 25) 40mg of soy isoflavones capsule (once daily) Other Names: Soylife 25
Placebo Comparator: starch Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive placebo	Drug: placebo starch placebo

Arm

Intervention/Treatment

Experimental: isoflavones

Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive isoflavones

Drug: isoflavones (Soylife 25)

40mg of soy isoflavones capsule (once daily)

Other Names:

Soylife 25

Placebo Comparator: starch

Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive placebo

Drug: placebo

starch placebo

Outcome Measures

Primary Outcome Measures

The primary safety endpoint is tolerability i.e. discontinuation due to an adverse event. The primary efficacy outcome will be an improvement in the urine flow rate by at least 2ml/sec after 12 months treatment when compared to placebo. [12 months]
The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in the International Prostate Symptom Score (IPSS) and Sf-36 respectively. [12 months]

Secondary Outcome Measures

The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in IPSS and Sf-36 respectively. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Chinese ethnicity
Age between 45-85 years
Diagnosed to have watchful waiting BPH (Qmax< 15 ml/sec together with a voided volume of more than 150 mls)
Not on any concurrent alternative medications for BPH
Mentally capable to give informed written consent and willing to comply with study requirements

Exclusion Criteria:

Prefers to have conventional medical or surgical treatment for BPH
Concurrent treatment for unstable chronic diseases including unstable angina, poorly controlled DM (HbA1c >7.5), less than 3 months post-MI or frequent exacerbation of COPD (more than 3x in the last year)
Known to have prostate cancer or kidney and/or liver failure
Urinary symptoms due to known causes other than BPH including neurogenic bladder, urinary tract infection, bladder cancer, bladder stone, urethral stricture
Previous history of prostatic surgery
Illiterate or having difficulty in filling in a patient diary