Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. ThuVARP was compared to TURP in men suitable for BPO surgery.
In this randomised, controlled, blinded, parallel group, pragmatic equivalence trial, men with bothersome Lower Urinary Tract Symptoms (LUTS) or Urinary Retention (UR) secondary to BPO were randomised (1:1) at the point of surgery, in seven UK hospitals, to receive ThuVARP or TURP. Patients were blinded until follow-up completion. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS), 12-months post-surgery. Equivalence was defined as a difference of ≤2·5 points for IPSS and ≤4ml/s for Qmax. Secondary outcomes included surgical, functional and quality of life (QoL) measures, and complications. Analysis was by intention to treat. Registered with the ISRCTN registry (ISRCTN00788389).
Between June 2014 and December 2016, 410 men were randomised, 205 per arm. TURP was superior for Qmax (means of 23·2ml/s (TURP, n=199) and 20·2ml/s (ThuVARP, n=197); adjusted difference in means -3·12 and 95% CI: -5·79, -0·45). Equivalence was demonstrated for IPSS (means of 6·3 (TURP, n=199) and 6·4 (ThuVARP, n=197); adjusted difference in means 0·28 and 95% CI: -0·92, 1·49). Mean hospital stay was 48hrs in both arms. Other functional, QoL and surgical outcomes (including blood transfusions) were comparable. 45% (91/204) versus 47% (96/203) of men experienced at least one complication for TURP and ThuVARP respectively.
TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS), 12-months post surgery, whilst TURP was superior for Qmax. Anticipated laser benefits of reduced hospital stay and complications were not observed.
- BTC (Bristol Trials Centre)