Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia
• Intervention / Treatment: Drug: isoflavones (Soylife 25); Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: School of Pharmacy, CUHK

Publications and helpful links

General Publications

• Wong WC, Wong EL, Li H, You JH, Ho S, Woo J, Hui E. Isoflavones in treating watchful waiting benign prostate hyperplasia: a double-blinded, randomized controlled trial. J Altern Complement Med. 2012 Jan;18(1):54-60. doi: 10.1089/acm.2010.0077.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: March 12, 2009
• First Submitted That Met QC Criteria: March 12, 2009
• First Posted (Estimate): March 13, 2009

Study Record Updates

• Last Update Posted (Estimate): March 13, 2009
• Last Update Submitted That Met QC Criteria: March 12, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: quality of life; benign prostate hyperplasia; randomized control trial; complementary & alternative medicine; uroflowmetry
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CUHK4453/05M