Multi-Center Randomized Controlled Blinded Study of the Prostatic Urethral Lift for the Treatment of LUTS Associated with Prostate Enlargement Due to BPH: The L.I.F.T. Study
Roehrborn CG, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Brown BT, McVary KT, Te AE, Gholami SS, Rashid P, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield SK, Borges FD, Rukstalis DB. J Urol. 2013 Jun 10. pii: S0022-5347(13)04597-7. doi: 10.1016/j.juro.2013.05.116. [Epub ahead of print]

Source

The University of Texas Southwestern Medical Center, Dallas, Texas.

Abstract

PURPOSE:

We report the first multi-center randomized blinded trial of the Prostatic Urethral Lift (PUL) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

MATERIALS AND METHODS:

Men of at least 50 years with American Urological Association Symptom Index (AUASI)ࣙ 13, a maximum flow rate (Qmax)≤ 12 ml/s, and a prostate 30-80 cc, were randomized 2:1 between PUL and sham. In PUL small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking PUL. The primary endpoint was comparison of AUASI reduction at 3 months. PUL arm subjects were followed to 1 year and assessed for LUTS, Qmax, quality of life (QOL), and sexual function.

RESULTS AND CONCLUSIONS:

206 men were randomized (140 PUL:66 sham). PUL and sham AUASI were reduced by 11.1±7.67 and 5.9±7.66, respectively, (p=0.003) thus meeting the primary endpoint. PUL subjects experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months respectively, p<0.001. Qmax increased 4.4 ml/s at 3 months and was sustained at 4.0 ml/s at 12 months, p<0.001. Adverse events were typically mild and transient. There was no occurrence of de novo ejaculatory or erectile dysfunction. The Prostatic Urethral Lift, reliably performed under local anesthesia, provides rapid and sustained improvement in symptoms and flow, while preserving sexual function.