Abstract
ABSTRACTObjective:To generate high-quality data comparing the clinical efficacy and safety profile between monopolar transurethral resection of the prostate (M-TURP) and bipolar plasmakinetic resection of the prostate (PK-TURP) for benign prostatic hyperplasia (BPH).Materials and Methods:Prospective, randomized, single-blinded study conducted in a tertiary-care public institution (Dec/2014-Aug/2016). Inclusion criteria: prostate of <80g in patients with drug-refractory lower urinary tract symptoms (LUTS), complications derived from BPH, or both. Exclusion criteria: a history of pelvic surgery/radiotherapy, neurogenic bladder dysfunction or documented/suspected prostate carcinoma. Treatment efficacy evaluated at 1, 3, 6 and 12 months. Efficacy outcomes: international prostate symptom score (IPSS), quality-of-life (QoL) score, international index of erectile function-5 (IIEF-5), maximum urinary flow rate (Qmax), postvoid residual urine (PVRU) volume, and prostate volume (PV). Complications and sequelae also assessed. Comparisons performed with parametric/non-parametric tests.Results:Out of the 100 hundred patients, 84 qualified for the analysis (45 M-TURP/39 PK-TURP). No significant differences found in baseline characteristics or operative data, except for a longer operative time in PK-TURP (MD:7.9min; 95%CI:0.13-15.74; p=0.04). No differences found in IPSS, Qmax or PVRU volume. QoL score at 12 months was higher in PK-TURP (MD:0,9points; 95%CI:0.18-1.64; p=0.01). No differences in sexual function, PV, complications or sequelae were found. This study is “rigorous” (Jadadscale) and has a low risk of bias (Cochrane-Handbook).Conclusions:Based on this controlled trial, there is not significant variation in effectiveness and safety between M-TURP and PK-TURP for the treatment of BPH. The small difference in QoL between PK-TURP and M-TURP at the one-year follow-up is not perceivable by the patients and, therefore, not clinically relevant.
Highlights
The field of minimally invasive surgical techniques for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) [1] has experienced extraordinary technological development
Inclusion criteria were prostate volume (PV) of
There were no significant differences neither in baseline characteristics (Table-1) nor in operative data (Table-2) between the groups except for operative time (7.9 minutes longer for plasmakinetic transurethral resection of the prostate (PK-TURP); 95%CI: 0.13-15.74; p=0.04)
Summary
The field of minimally invasive surgical techniques for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) [1] has experienced extraordinary technological development. PK-TURP procedures have a grade A recommendation in the guidelines [2], most studies comparing monopolar transurethral resection of the prostate (M-TURP) and PK-TURP are rated as “poor quality” on the Jadad scale (≤3 points) [3], has methodological robustness labeled as “low” according to the Cochrane Handbook checklist [4], or both. The objective of this study was to generate the much-needed high-quality data that meets the requirements of both the Jadad scale and Cochrane Handbook checklist and compare M-TURP and PK-TURP in terms of efficacy (primary outcome), quality of life (QoL), sexual function, intraoperative, perioperative, and complications as well as sequelae during the 12 months of follow-up (secondary outcomes)
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