Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study.
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).


METHODS
Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS.


METHODS
PUL or TURP.


METHODS
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.


CONCLUSIONS
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.


RESULTS
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.


BACKGROUND
ClinicalTrials.gov NCT01533038.
Department of Urology, Herlev Hospital, Herlev, Denmark.
Jens
J
Sønksen
Frimley Park Hospital NHS Foundation Trust, Surrey, UK.
Neil J
NJ
Barber
Department of Urology, Taunton and Somerset NHS Trust, Taunton, UK.
Mark J
MJ
Speakman
PAN Klinik Köln, Köln, Germany.
Richard
R
Berges
Department of Urology, University Hospital Freiburg, Freiburg, Germany.
Ulrich
U
Wetterauer
City Hospitals Sunderland, Sunderland, UK.
Damien
D
Greene
University Clinic of Lübeck, Lübeck, Germany.
Karl-Dietrich
KD
Sievert
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Christopher R
CR
Chapple
Urology Division, Instituto San Rafaele, Milan, Italy.
Francesco
F
Montorsi
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Jacob M
JM
Patterson
Department of Urology, Herlev Hospital, Herlev, Denmark.
Lasse
L
Fahrenkrug
Department of Urology, University Hospital Freiburg, Freiburg, Germany.
Martin
M
Schoenthaler
Department of Urology, Ludwig-Maximilians University, Munich, Germany. Electronic address: christian.gratzke@med.uni-muenchen.de.
Christian
C
Gratzke
D000368:Aged; D000369:Aged, 80 and over; D007172:Erectile Dysfunction / Q000209:etiology / Q000503:physiopathology; D005060:Europe; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010410:Penile Erection; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D011788:Quality of Life; D020127:Recovery of Function; D012307:Risk Factors; D013997:Time Factors; D020728:Transurethral Resection of Prostate / Q000009:adverse effects; D016896:Treatment Outcome; D014521:Urethra / Q000503:physiopathology / Q000601:surgery*; D014549:Urinary Incontinence / Q000209:etiology
Benign Prostatic Hyperplasia; Ejaculation; Minimally-Invasive; Quality of Life; TURP