NeoTract announced the publication of the four-year follow-up results from its pivotal L.I.F.T. IDE trial, which evaluated the safety and effectiveness of the UroLift system in patients with symptomatic benign prostatic hyperplasia (BPH).
The study, published in the journal Urologic Clinics of North America, is titled “Prostatic Urethral Lift: A Unique Minimally Invasive Surgical Treatment of Male Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.”
UroLift is a U.S. Food and Drug Administration (FDA)-cleared and minimally invasive device for the treatment of lower urinary tract symptoms due to BPH. UroLift’s permanent implants, delivered through an outpatient transurethral procedure, are designed to relieve prostate obstruction and open the urethra without cutting, heating, or removing prostate tissue.
Claus Roehrborn, MD, co-principal investigator for the L.I.F.T. clinical program, and professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas, said in a press release: “The pivotal L.I.F.T. randomized study confirms that the rapid and significant symptom improvement from treatment with the UroLift System is sustained for at least four years, with durable improved quality of life and preservation of sexual function.
“These clinical outcomes, in combination with UroLift’s procedural benefits, make it a compelling treatment option for a significant population of men with voiding symptoms due to benign prostatic hyperplasia (enlarged prostate gland).”
L.I.F.T was a multi-center, randomized, patient- and outcome assessor-blinded trial of the Prostatic Urethral Lift (PUL) in men with lower urinary tract symptoms (LUTS). The published data shows that more than 86 percent of the original group of patients enrolled after four years no longer sought additional treatment for BPH.
Four-year results also revealed that UroLift system treatment provided:
- A rapid reduction in symptoms after the procedure without diminishing sexual function
- Sustained effect, with improvements from baseline IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) scores remaining 41% and 62%, respectively;
- An improved 52% in quality of life (QoL) score
“The publication of this long-term clinical data is an exciting milestone for NeoTract,” said Dave Amerson, president and CEO of NeoTract. “We are committed to helping men return to normal urinary function, preserve sexual vitality and to providing a great alternative to BPH medications with this safe and effective treatment option – the only BPH procedure that does not require cutting, heating or removal of the prostate tissue.”
Benign prostatic hyperplasia is a common condition in which the prostate enlarges as men get older. While BPH is a benign and unrelated to prostate cancer, it can greatly affect a man’s quality of life. Medication is normally the first-line treatment for the condition, but relief can be inadequate and temporary and result in side effects. Surgery is also an option and effective in relieving symptoms, but patients can be at risk of adverse effects that include erectile dysfunction, retrograde ejaculation, and urinary incontinence.