Design: Randomised controlled trial
Population: 64 men having transrectal 12-core prostate biopsy, Nigeria
Primary outcome: Post-biopsy pain and bleeding
Effect: Haematuria 37.5% vs 31.3%; rectal bleeding 31.3% vs 28.1%; not significant

A Nigerian randomised trial allocated 64 men having digitally guided transrectal 12-core prostate biopsy to a 16G semi-automatic needle or a 16G fully automatic biopsy gun.

Haematuria occurred in 37.5% with the semi-automatic needle and 31.3% with the gun; significant rectal bleeding in 31.3% and 28.1%. Pain was somewhat higher with the semi-automatic needle. None of the differences was statistically significant.

With 32 men per arm the trial could only detect large differences. In settings where transrectal digitally guided biopsy is still common, either device is acceptable on these data; the bigger gains in safety come from the biopsy route and antibiotic practice.

Either device is acceptable for systematic prostate biopsy on current evidence
Warn patients that haematuria and rectal bleeding are common after transrectal biopsy
Consider transperineal biopsy where available to reduce infection risk
Give clear advice on when to return with bleeding, fever or retention

Why it matters

Relevant to units still choosing between low-cost and automatic biopsy devices.

The statistics, in plain English

With 32 patients per group, the trial was too small to detect modest differences; 'no significant difference' here means no large difference, not proof of equivalence.