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Three year results of the prostatic urethral L.I.F.T. study.

Authors :
Roehrborn CG
Rukstalis DB
Barkin J
Gange SN
Shore ND
Giddens JL
Bolton DM
Cowan BE
Cantwell AL
McVary KT
Te AE
Gholami SS
Moseley WG
Chin PT
Dowling WT
Freedman SJ
Incze PF
Coffield KS
Borges FD
Rashid P
Source :
The Canadian journal of urology [Can J Urol] 2015 Jun; Vol. 22 (3), pp. 7772-82.
Publication Year :
2015

Abstract

Introduction: To report the three year results of a multi-center, randomized, patient and outcome assessor blinded trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).<br />Materials and Methods: At 19 centers in North America and Australia, 206 subjects = 50 years old with International Prostate Symptom Score (IPSS) ≥ 13, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume between 30 cc-80 cc were randomized 2:1 to the PUL procedure or sham control. PUL involved placing permanent UroLift implants into the lateral lobes of the prostate to enlarge the urethral lumen. After randomized comparison at 3 months, PUL patients were followed to 3 years. LUTS severity (IPSS), quality of life, Qmax, sexual function, and adverse events were assessed throughout follow up.<br />Results: The therapeutic effect of PUL regarding IPSS was 88% greater than sham at 3 months. Average improvements from baseline through 3 years were significant for total IPSS (41.1%), quality of life (48.8%), Qmax (53.1%), and individual IPSS symptoms. Symptomatic improvement was independent of prostate size. There were no de novo, sustained ejaculatory or erectile dysfunction events and all sexual function assessments showed average stability or improvement after PUL. Fifteen of the 140 patients originally randomized to PUL required surgical reintervention for treatment failure within the first 3 years.<br />Conclusions: PUL offers rapid improvement in voiding and storage symptoms, quality of life and flow rate that is durable to 3 years. Patients demonstrated a level of symptom relief that is associated with significant patient satisfaction. PUL, a minimally invasive procedure, is very effective in treating bothersome LUTS secondary to benign prostatic obstruction (BPO) and is unique in its ability to preserve total sexual function while offering a rapid return to normal physical activities.

Details

Language :
English
ISSN :
1195-9479
Volume :
22
Issue :
3
Database :
MEDLINE
Journal :
The Canadian journal of urology
Publication Type :
Academic Journal
Accession number :
26068624