Midterm results from an international multicentre randomised controlled trial comparing bipolar with monopolar transurethral resection of the prostate.

BACKGROUND

Pooled data from randomised controlled trials (RCTs) with short-term follow-up have shown a safety advantage for bipolar transurethral resection of the prostate (B-TURP) compared with monopolar TURP (M-TURP). However, RCTs with follow-up >12 mo are scarce.

OBJECTIVE

To compare the midterm safety/efficacy of B-TURP versus M-TURP.

DESIGN, SETTING, AND PARTICIPANTS: From July 2006 to June 2009, TURP candidates with benign prostatic obstruction were consecutively recruited in four centres, randomised 1:1 into the M-TURP or the B-TURP arm and regularly followed up to 36 mo postoperatively. A total of 295 patients were enrolled.

INTERVENTION

M-TURP or B-TURP using the AUTOCON II 400 electrosurgical unit.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Safety was estimated by complication rates with a special emphasis on urethral strictures (US) and bladder neck contractures (BNCs) recorded during the short-term (up to 12 mo) and midterm (up to 36 mo) follow-up. Efficacy quantified by changes in maximum urine flow rate, postvoid residual urine volume, and International Prostate Symptom Score was compared with baseline, and reintervention rates in each arm were also evaluated.

RESULTS AND LIMITATIONS

A total of 279 patients received treatment after allocation. Mean follow-up was 28.8 mo. A total of 186 of 279 patients (66.7%) completed the 36-mo follow-up. Posttreatment withdrawal rates did not differ significantly between arms. Safety was assessed in 230 patients (82.4%) at a mean follow-up of 33.4 mo. Ten US cases were seen in each arm (M-TURP vs B-TURP: 9.3% vs 8.2%; p=0.959); two versus eight BNC cases (M-TURP vs B-TURP: 1.9% vs 6.6%; p=0.108) were collectively detected at the midterm follow-up. Resection type was not a significant predictor of the risk of US/BNC formation. Efficacy was similar between arms and durable. A total of 10 of 230 patients (4.3%) experienced failure to cure and needed reintervention without significant differences between arms. High overall reintervention rates, withdrawal rates, and sample size determination not based on US/BNC rates represent potential limitations.

CONCLUSIONS

The midterm safety and efficacy of B-TURP and M-TURP are comparable.

TRIAL REGISTRATION

Netherlands Trial Register, NTR703 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=703).