| Methods | Multisite study Randomization: envelope selection Patients blinded; providers blinded |
|
| Participants | Geographic region: Shangai, China Study setting: urology clinic and community hospital N = 94 Baseline IPSS: NA Baseline prostate volume:Prostataplex™ 47.7 cc, Placebo 48.4 cc Mean age: 65.0 Age range: 62 to 68 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: 2 |
|
| Outcomes | Maximum urinary flow rate | |
| Notes | ||
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Adequate sequence generation? | Unclear | B - Significant difference in baseline inter- group IPSS total score |
| Allocation concealment? | Yes | A - Adequate |
| Blinding? All outcomes |
Yes | A - Adequate |
| Incomplete outcome data addressed? All outcomes |
Yes | A - Per protocol analysis |
| Free of selective reporting? | Yes | A - Adequate |
| Free of other bias? | Yes | A - Adequate |
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