Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

NCT00861588 | Completed

• 1 other identifier: CUHK4453/05M
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostate Hyperplasia

Keywords

complementary & alternative medicine; randomized control trial; uroflowmetry; quality of life; benign prostate hyperplasia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  12 months

Study Arms (2)

isoflavones

EXPERIMENTAL

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

Drug: isoflavones (Soylife 25)

starch

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

isoflavones (Soylife 25) DRUG

40mg of soy isoflavones capsule (once daily)

Also known as: Soylife 25

isoflavones

placebo DRUG

starch placebo

starch

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• School of Pharmacy, CUHK: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 22268969 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Isoflavones

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: February 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 13, 2009

Record last verified: 2009-03

Locations

HK (1)