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3 Year Results of a Prospective Multi-Center Study on Local Anesthesia for the Prostatic Urethral Lift (PUL)

Login to Access Video or Poster Abstract: MP27-17
Sources of Funding: NeoTract, Inc.

Introduction

The Prostatic Urethral Lift (PUL) is a minimally invasive procedure for lower urinary tract symptoms (LUTS) that may be conducted in the office setting. In order to characterize procedure tolerance under local anesthesia, peri-operative recovery, and long-term outcomes, PUL was studied in a multi-center, prospective, non-randomized trial.

Methods

At 7 US centers, 51 men with International Prostate Symptom Score (IPSS)>12, peak flow rate ? 12mL/s, and prostate volume < 80cc were treated with PUL wherein UroLift® implants were transurethrally placed into the lateral lobes to enlarge the urethral lumen. Patient experience was measured via validated instruments including pelvic pain visual analog scale (VAS), Quality of Recovery VAS (QoR), Patient General Impression Index (PGI-I), Work Productivity and Activity Impairment Questionnaire (WPAI).

Results

All procedures were well tolerated under local anesthesia. Symptom relief was significant by 1 month (IPSS 48%, QoL 44%) and sustained through 3 years (IPSS 42%, QoL 50%). 80% of patients were catheter free after PUL and the average for all patients was less than one day. There was no de novo, sustained occurrence of ejaculatory or erectile dysfunction. By one month, 86% of subjects achieved high quality recovery per QoR, 90% reported improvement through PGI-I, 96% had returned to pre-operative activity, 100% of employed subjects had returned to work. Average erectile function scores did not change, and both ejaculatory function and bother were improved (p<0.001).

Conclusions

The PUL procedure is well tolerated under local anesthesia, rarely requires postoperative catheterization, and is associated with high quality recovery experiences. In addition, the results of this study indicate that PUL provides durable symptom relief to patients, as IPSS and quality of life scores remain significantly improved at 3 years. PUL offers patients a minimally invasive option for rapid, sustained LUTS relief and preserved sexual function.

Funding

NeoTract, Inc.

Authors
Steven Gange
Neal Shore
Sheldon Freedman
William Moseley
Sean Heron
Ronald Tutrone
Thomas Brown
Jack Barkin
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