Login to Access Video or Poster Abstract: MP27-18
Sources of Funding: NeoTract, Inc.

Introduction

PUL is a unique, non-thermal approach to treating lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia. We present the 4-year data from a sham to Prostatic Urethral Lift (PUL) crossover study in which each patient served as his own control.

Methods

53 patients underwent control sham procedure as part of a blinded, controlled study. After 3 months, these men with symptomatic LUTS were treated with crossover PUL that involved placing UroLift® implants into the obstructing lateral lobes of the prostate. They were followed for 4 years with validated tools such as International Prostate Symptom Score (IPSS), quality of life score (QoL), BPH Impact Index (BPH II), peak flow rate, sexual function scores, and adverse event reporting.

Results

Average IPSS improved after sham but returned to near baseline after 3 months, while peak flow rate (Qmax) remained mildly elevated (Fig 1). At 4 years after crossover PUL, average scores for IPSS, QoL, and BPHII remained improved 45%, 49%, and 44% from baseline, respectively (p<0.001). Average peak flow rate increase of at least 50% over baseline was demonstrated at 4 years (p=0.01). On average, patients returned to normal activity within 7 days. Related adverse effects were typically transient and mild to moderate in severity. There were no reported instances of de novo, sustained erectile or ejaculatory dysfunction.

Conclusions

Similar to other publications, the 4 year results of the crossover study indicate the PUL procedure can result in rapid and durable improvement in symptoms, quality of life, and peak flow rate. Subjects report minimal adverse effects and return to normal quickly. Sexual function appears to be preserved. This study offers a unique perspective on the effectiveness of PUL, as the sham response is quantified for each patient. PUL is demonstrated to have a significant, non-placebo response that is durable to four years.

Funding

NeoTract, Inc.