Bipolar Enucleation of the Prostate Versus Transurethral Resection of the Prostate: A Prospective Randomized Controlled Noninferiority Trial.

BACKGROUND AND

OBJECTIVE

Transurethral resection of the prostate (TURP) is the standard surgical treatment for moderate-sized benign prostatic enlargement (BPE). We evaluated whether bipolar enucleation of the prostate (BipolEP) is noninferior to TURP for 12-mo symptom relief.

METHODS

Open-label, two-center, parallel-group, randomized noninferiority trial: men with BPE (volume 40-150 ml; International Prostate Symptom Score [IPSS] ≥15; maximum urinary flow rate ≤15 ml/s or urinary retention), randomized 1:1 (minimization stratified by prostate size and catheterization status) to TURP or BipolEP.

PRIMARY OUTCOME: 12-mo IPSS (noninferiority margin 3 points); secondary outcomes: tissue-resection efficiency (g/min) and complications (Clavien-Dindo [CD]).

ANALYSES: per protocol and intention to treat.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03503721; funding: none.

KEY FINDINGS AND LIMITATIONS: Eighty-four men were randomized (42 per arm); 66 (79%) were included in the primary per-protocol analysis. Median 12-mo IPSS score was five in both groups; the estimated difference (TURP-BipolEP) was 0 points (90% confidence interval -2 to 1), confirming noninferiority (pnon-inf = 0.02). BipolEP removed more tissue (38.4 vs 25.0 g) despite longer operative time (86 vs 67 min) and achieved modestly higher resection efficiency (0.5 vs 0.4 g/min; p = 0.007). Within 30 d, CD 1-2 were more frequent with BipolEP (54% vs 28%), whereas CD ≥3 occurred only after TURP (10%; p = 0.02). No differences in CD from 1 to 12 mo (p > 0.9).

MAIN LIMITATION: follow-up duration.

INTERVENTION: TURP vs BipolEP.

CONCLUSIONS AND CLINICAL IMPLICATIONS: BipolEP is noninferior to TURP for 12-mo symptom relief, with greater tissue removal despite longer operative time and comparable safety. These findings support BipolEP as an alternative to TURP for moderate-sized prostates, although longer follow-up is required.