BACKGROUND: No data have been published on the midterm efficacy of bipolar transurethral resection of the prostate (TURP). OBJECTIVE: To evaluate 4-yr results from a prospective randomised trial comparing bipolar TURP with standard monopolar TURP. DESIGN, SETTING, AND PARTICIPANTS: Seventy patients with symptomatic benign prostatic hyperplasia were enrolled in this prospective randomised controlled trial in a tertiary-care institution. Inclusion criteria were age > 50 yr, good performance status, urinary retention, International Prostate Symptom Score (IPSS) > or = 18, and maximal flow rate (Q(max)) < or = 15 ml/s. Exclusion criteria were prostate volume < 30 cm(3), documented or suspected prostate cancer, neurogenic bladder, bladder stone or diverticula, urethral stricture, and maximal bladder capacity > 500 ml. INTERVENTION: Patients underwent standard or bipolar plasmakinetic TURP performed by the same surgeon using the same surgical technique. MEASUREMENTS: Treatment efficacy was evaluated at 1, 2, 3, and 4 yr by comparing urinary flow rates, IPSS, and estimated postvoid residual (PVR) urine volume. Midterm complications were also recorded. RESULTS AND LIMITATIONS: The number of dropouts was not statistically significantly different in the two groups (p=0.2). The significant improvements in both groups were maintained at 4 yr for the IPSS, quality of life score, Q(max), and PVR versus baseline values. The main outcome variables at 4 yr for bipolar and monopolar TURP were mean IPSS 6.9 and 6.4 (p=0.58); mean Q(max) 19.8 ml/s and 21.2 ml/s (p=0.44), and mean PVR volume 42 ml and 45 ml (p=0.3). Overall, 2 of 32 (6.2%) and 3 of 31 (9.6%) patients required reoperation because of late complications (p=0.15). The major study limitation was the small sample size. CONCLUSIONS: This study represents the secondary, midterm analysis of a previously published trial. Our 4-yr data confirm our initial positive findings for the efficacy and safety of bipolar plasmakinetic TURP. Larger well-designed studies are needed to corroborate these findings.
RCT Entities:
BACKGROUND: No data have been published on the midterm efficacy of bipolar transurethral resection of the prostate (TURP). OBJECTIVE: To evaluate 4-yr results from a prospective randomised trial comparing bipolar TURP with standard monopolar TURP. DESIGN, SETTING, AND PARTICIPANTS: Seventy patients with symptomatic benign prostatic hyperplasia were enrolled in this prospective randomised controlled trial in a tertiary-care institution. Inclusion criteria were age > 50 yr, good performance status, urinary retention, International Prostate Symptom Score (IPSS) > or = 18, and maximal flow rate (Q(max)) < or = 15 ml/s. Exclusion criteria were prostate volume < 30 cm(3), documented or suspected prostate cancer, neurogenic bladder, bladder stone or diverticula, urethral stricture, and maximal bladder capacity > 500 ml. INTERVENTION: Patients underwent standard or bipolar plasmakinetic TURP performed by the same surgeon using the same surgical technique. MEASUREMENTS: Treatment efficacy was evaluated at 1, 2, 3, and 4 yr by comparing urinary flow rates, IPSS, and estimated postvoid residual (PVR) urine volume. Midterm complications were also recorded. RESULTS AND LIMITATIONS: The number of dropouts was not statistically significantly different in the two groups (p=0.2). The significant improvements in both groups were maintained at 4 yr for the IPSS, quality of life score, Q(max), and PVR versus baseline values. The main outcome variables at 4 yr for bipolar and monopolar TURP were mean IPSS 6.9 and 6.4 (p=0.58); mean Q(max) 19.8 ml/s and 21.2 ml/s (p=0.44), and mean PVR volume 42 ml and 45 ml (p=0.3). Overall, 2 of 32 (6.2%) and 3 of 31 (9.6%) patients required reoperation because of late complications (p=0.15). The major study limitation was the small sample size. CONCLUSIONS: This study represents the secondary, midterm analysis of a previously published trial. Our 4-yr data confirm our initial positive findings for the efficacy and safety of bipolar plasmakinetic TURP. Larger well-designed studies are needed to corroborate these findings.
Authors: Cosimo De Nunzio; Riccardo Lombardo; Riccardo Autorino; Antonio Cicione; Luca Cindolo; Rocco Damiano; Marco De Sio; Mario Falsaperla; Giorgio Franco; Mauro Gacci; Costantino Leonardo; Fabrizio Presicce; Andrea Tubaro Journal: Int Urol Nephrol Date: 2013-05-31 Impact factor: 2.370