| Methods |
Multisite study
Randomization: envelope selection
Blinding: patients, providers |
| Participants |
Geographic region: Shangai, China
Study setting: urology clinic and community hospital
N = 94
Baseline IPSS: NR
Baseline prostate volume: Prostataplex™ 47.7 cc; placebo 48.4 cc
Mean age (range): 65 (62 to 68) years
Race: Chinese
Diagnostic criteria: newly diagnosed LUTS associated with BPH based on urological symptoms, including nocturia, incomplete emptying, urinary frequency, intermittence, weak stream, straining and urgency. |
| Interventions |
Control: matching placebo
Treatment: Prostataplex™ 2 pills/daily
Study duration: 3 months
Lost to follow‐up: n = 2 |
| Outcomes |
Maximum urinary flow rate |
| Notes |
Exclusion: history of prostate cancer and the use of any drugs, herbs or other nonprescription preparations for LUTS associated with BPH within 4 weeks of screening, including finasteride, α or ß‐blockers, diuretics, calcium channel blockers and anticholinergic drugs. Abnormal laboratory parameters, including PSA > 4 ng/mL, serum creatinine more than 160 µmol/la urine bacterial count greater than 100,000/ml, BUN > 8 mg/dL, MFR > 15 mL/s and voiding volume < 150 mL, were also grounds for exclusion. Additional exclusion criteria were patient inability to understand or follow the study protocol, current or previous participation in another clinical trial, BPH judged by a urologist to require surgical treatment, previous bladder or prostate surgery, micturition problems associated with an identified bladder pathology (neurogenic bladder, bladder neck stenosis, lithiasis or bladder cancer), urethral stricture, recurrent urinary tract infections, known renal, hepatic or cardiac insufficiency, diabetes mellitus, recent MI, known alcohol abuse, known sensitivity to the ingredients in the product, significant depression or other psychiatric disease noted during the initial screening, any other cancer in the last 5 years except skin cancer and being on anticoagulation therapy. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"blindly randomized" |
| Allocation concealment (selection bias) |
Low risk |
adequate |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
adequate |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
unclear |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
per protocol analysis |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
