title: Three year results of the prostatic urethral L.I.F.T. study.
abstract: BACKGROUND
  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).
  
  
  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.
  
  
  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.
  
  
  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.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Rukstalis
authors.forename: Jack
authors.initials: J
authors.lastname: Barkin
authors.forename: Steven N
authors.initials: SN
authors.lastname: Gange
authors.forename: Neal D
authors.initials: ND
authors.lastname: Shore
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Giddens
authors.forename: Damien M
authors.initials: DM
authors.lastname: Bolton
authors.forename: Barrett E
authors.initials: BE
authors.lastname: Cowan
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Cantwell
authors.forename: Kevin T
authors.initials: KT
authors.lastname: McVary
authors.forename: Alexis E
authors.initials: AE
authors.lastname: Te
authors.forename: Shahram S
authors.initials: SS
authors.lastname: Gholami
authors.forename: William G
authors.initials: WG
authors.lastname: Moseley
authors.forename: Peter T
authors.initials: PT
authors.lastname: Chin
authors.forename: William T
authors.initials: WT
authors.lastname: Dowling
authors.forename: Sheldon J
authors.initials: SJ
authors.lastname: Freedman
authors.forename: Peter F
authors.initials: PF
authors.lastname: Incze
authors.forename: K Scott
authors.initials: KS
authors.lastname: Coffield
authors.forename: Fernando D
authors.initials: FD
authors.lastname: Borges
authors.forename: Prem
authors.initials: P
authors.lastname: Rashid
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003558:Cystoscopy; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D011467:Prostate / Q000473:pathology*; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000473:pathology; D053448:Prostatism / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D019736:Prostheses and Implants / Q000009:adverse effects; D011788:Quality of Life; D012086:Reoperation; D012720:Severity of Illness Index; D019529:Sexuality; D016896:Treatment Outcome; D014521:Urethra / Q000601:surgery*; D014563:Urodynamics