Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate: 12-month Results from the BPH6 Study

TY - JOUR

T1 - Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate

T2 - 12-month Results from the BPH6 Study

AU - Sønksen, Jens

AU - Barber, Neil J

AU - Speakman, Mark J

AU - Berges, Richard

AU - Wetterauer, Ulrich

AU - Greene, Damien

AU - Sievert, Karl-Dietrich

AU - Chapple, Christopher R

AU - Montorsi, Francesco

AU - Patterson, Jacob M

AU - Fahrenkrug, Lasse

AU - Schoenthaler, Martin

AU - Gratzke, Christian

N1 - Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Background Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral lift (PUL) is a treatment option that may overcome these limitations. Objective To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). Design, setting, and participants Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS. Intervention PUL or TURP. Outcome measurements and statistical analysis The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. Results and limitations Preservation of ejaculation and quality of recovery were superior with PUL (p < 0.01). Significant symptom relief was achieved in both treatment arms. The study demonstrated not only noninferiority but also superiority of PUL over TURP on the BPH6 endpoint. Study limitations were the small sample size and the inability to blind participants to enrollment arm. Conclusions Assessment of individual BPH6 elements revealed that PUL was superior to TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. Patient summary In this study, participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. Trial registration ClinicalTrials.gov NCT01533038.

AB - Background Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral lift (PUL) is a treatment option that may overcome these limitations. Objective To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). Design, setting, and participants Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS. Intervention PUL or TURP. Outcome measurements and statistical analysis The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. Results and limitations Preservation of ejaculation and quality of recovery were superior with PUL (p < 0.01). Significant symptom relief was achieved in both treatment arms. The study demonstrated not only noninferiority but also superiority of PUL over TURP on the BPH6 endpoint. Study limitations were the small sample size and the inability to blind participants to enrollment arm. Conclusions Assessment of individual BPH6 elements revealed that PUL was superior to TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. Patient summary In this study, participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. Trial registration ClinicalTrials.gov NCT01533038.

U2 - 10.1016/j.eururo.2015.04.024

DO - 10.1016/j.eururo.2015.04.024

M3 - Journal article

C2 - 25937539

SN - 0302-2838

VL - 68

SP - 643

EP - 652

JO - European Urology

JF - European Urology

IS - 4

ER -