Prostatic urethral lift (PUL) for patients with bothersome lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) is associated with rapid improvement in symptoms and quality of life durable out to 3 years, according to recently published findings from a randomized, sham-controlled, parallel-group, prospective study.
“This study offers data from the largest population with the longest follow up of a randomized trial of the PUL procedure,” a research team led by Claus G. Roehrborn, MD, of the University of Texas Southwestern Medical Center in Dallas, wrote in The Canadian Journal of Urology (2015;22:7772-7782). “PUL also demonstrated a freedom from stress urinary incontinence, transfusion, and iatrogenic sexual dysfunction commonly associated with other BPH procedures.”
The study included 206 patients from 19 centers in North America and Australia.
PUL is a minimally invasive, mechanical approach to treating BPH that uses non-absorbable suture implants with a metallic anchor at each end to pull the lateral lobes of the prostate apart, the investigators explained. The implants are placed under transurethral, cystoscopic guidance. In previous studies, PUL has been shown to offer rapid and significant relief of lower urinary tract symptoms (LUTS) with minimal side effects, as well as preservation of erectile and ejaculatory function.
The therapeutic effect of PUL with respect to International Prostate Symptom Score (IPSS) was 88% greater than that associated with the sham procedure at 3 months, Dr. Roehrborn’s team noted. The average improvements from baseline through 3 years were significant for total IPSS (41.1%), quality of life (QoL, 48.8%), peak flow rate (Qmax, 53.1%), and individual IPSS components. Symptomatic improvement was independent of prostate size, they reported.
A total of 15 (10.7%) of the 140 men originally assigned to the PUL group required surgical reintervention for treatment failure within 3 years. The rate was similar to rates reported after transurethral resection of the prostate (TURP) and laser vaporization, according to the investigators.
The men in the PUL group had no de novo sustained erectile or ejaculatory dysfunction. “All sexual function assessments showed average stability or improvement after PUL,” they wrote.
“The PUL procedure offers a new solution for patients suffering from BPH,” Dr. Roehrborn’s team concluded. “It addresses a need for clinically meaningful relief from LUTS that is superior to medications but without the morbidity and sexual side effects caused by TURP, laser or medical therapy while being a quick, safe, minimally invasive outpatient procedure.”
The study population consisted of participants in the L.I.F.T. (Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of LUTS secondary to BPH) study. Inclusion criteria included age older than 50 years, IPSS of 3 or greater, Qmax of 12 mL/sec or less, prostate volume of 30–80 cc, absence of obstructive median lobe, and absence of active urinary tract infection.
In a separate study of 102 men with symptomatic BPH who underwent PUL, Thomas A. McNicholas, MD, of the University of Hertfordshire, Stevenage, U.K., and colleagues concluded that the procedure had promise for BPH. The study, published in European Urology (2013:64;292-299), found that patients experienced symptom relief by 2 weeks that was sustained to 12 months, with mean IPSS, QoL, and Qmax improving significantly by 36%, 39%, 38%, respectively, by 2 weeks, and 52%, 53%, and 51% at 12 months. According to the researchers, adverse events were transient and mild.