24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham.
OBJECTIVE
To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study.


METHODS
In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift®system) into the prostatic lateral lobes. Patients were followed for 3 months after the sham procedure and then for 24 months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events.


RESULTS
At 24 months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P < 0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1 month with significant decay by 3 months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction.


CONCLUSIONS
The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24 months. Morbidity is low and sexual function is preserved.
Wake Forest Baptist Health, Winston Salem, NC, USA.
Daniel
D
Rukstalis
Urology Centre, Port Macquarie, NSW, Australia.
Prem
P
Rashid
Carolina Urologic Research Center, Myrtle Beach, SC, USA.
William K
WK
Bogache
Chesapeake Urology Research Associates, Baltimore, MD, USA.
Ronald F
RF
Tutrone
Toronto Urology Clinical Study Group, Toronto, ON, Canada.
Jack
J
Barkin
Illawarra Urology, Figtree, NSW, Australia.
Peter T
PT
Chin
Sydney Adventist Hospital Clinical School, Wahroonga, NSW, Australia.
Henry H
HH
Woo
Advanced Urology Institute, Daytona Beach, FL, USA.
Anthony L
AL
Cantwell
Urology Associates of Denver, Englewood, CO, USA.
Barrett E
BE
Cowan
Austin Health, Heidelberg, Vic., Australia. damienmbolton@gmail.com.
Damien M
DM
Bolton
D000328:Adult; D001315:Australia; D002170:Canada; D018592:Cross-Over Studies; D003558:Cystoscopy / Q000379:methods; D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D011788:Quality of Life; D053825:Suburethral Slings; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
benign prostatic hyperplasia; lower urinary tract symptoms; minimally invasive surgical therapy; sexual function