Lin VC-H, Liao C-H, Kuo H-C. Progression of Lower Urinary Tract Symptoms After Discontinuation of 1 Medication From 2-Year Combined Alpha-blocker and 5-Alpha–reductase Inhibitor Therapy for Benign Prostatic Hyperplasia in Men–A Randomized Multicenter Study. Urology 2014;83(2):416-21
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/24332123
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 240 enrolled, 230 completed
Age: 78.3 ± 8.19 years Sex: 0 female, 240 male Participants with dementia: no Inclusion criteria: · Moderate-to-severe lower urinary tract symptoms, and · International Prostate Symptom Score >8, and · Quality of life index >4, AND · Total prostatic volume >30 mL by transrectal ultrasonography of the prostate, and · Maximum flow rate <15 mL/s with minimal voided volume S125 mL. · If patients had serum prostate-specific antigen S4 ng/mL, transrectal ultrasonography -guided biopsy of the prostate must be performed to exclude the presence of prostate cancer. Exclusion criteria: · History or evidence of prostate cancer · Neurogenic bladder · Recurrent urinary tract or prostate infection · Post-void residual urine of >150 mL, · Urinary retention within 3 months before entry of study · Under the treatment of anti-androgen · Any phytotherapy within 6 months before study enrollment Country: Taiwan Setting: Community |
| Interventions | Medicine: Alpha-blocker (doxazosin 4 mg) and 5-Alphaereductase Inhibitor Therapy (dutasteride 0.5 mg)
Withdrawal schedule: Not described |
| Outcomes | Successful deprescribing
Clinically-relevant progression of benign prostatic hypertrophy |
| Dates | Dates: Not described
Follow-up duration: 3 years (2 years dual therapy, and 1 year follow-up monotherapy) |
| Funding sources | Not stated |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Does not state method, only objection.
“The randomization was based on the permuted block randomization code to provide an approximately 1:1 ratio of patients in each group.” |
| Allocation concealment (selection bias) | High risk | Open study |
| Blinding of participants and personnel (performance bias) | High risk | Open study |
| Blinding of outcome assessment (detection bias) | High risk | Open study |
| Incomplete outcome data (attrition bias) | Low risk | Although there were no pre-published outcomes, the stated outcomes were all reported. |
| Selective reporting (reporting bias) | Low risk | The follow-up of 230 out of 240 participants over three years represents a good attrition. |
| Other bias | Low risk | Funding source not declared |