NeoTract announced the enrollment of the first patients in the MedLift U.S. IDE trial investigating the safety and effectiveness of the UroLift System for the treatment of people with benign prostatic hyperplasia (BPH) who have an obstructive median lobe.
The UroLift is a permanent implant, lifting the urethra out of the way of the prostate gland. The implant is fitted during a minimally invasive procedure, with no need for hospitalization. Earlier data from clinical trials show that the UroLift improves symptoms and urinary flow rate without compromising sexual function. Most adverse effects — including the presence of blood in the urine, difficulty in urinating, urgent urination, pelvic pain, and urge incontinence — were mild to moderate and resolved within two to four weeks after the procedure.
Obstructive median lobes are present in about 5 percent to 10 percent of BPH patients, and the condition is currently considered a contraindication for the UroLift System. The trial, being held at a number of sites across the U.S. and recruiting patients, expects to conclude in February 2018.
“Unlike other BPH procedures, the UroLift System directly opens the urethra without cutting, heating, or removing prostate tissue. In this way patients experience very rapid and durable relief,” Euclid deSouza, principal investigator at the Adult and Pediatric Urology site in Omaha, Nebraska, said in a press release. “This treatment option has been very successful for many of my BPH patients who are unhappy with medical therapy and concerned about the lengthy recovery and side effects common with other procedures.”
Ronald Tutrone, principal investigator at Chesapeake Urology in Towson, Maryland, added: “Most BPH men have some form of a median lobe and UroLift is an effective treatment option, but in a small subset this lobe can become obstructive. UroLift would be valuable to patients with obstructive median lobes since their treatment options are limited. Patients I see with obstructive median lobes typically require more aggressive treatment which can come with more complications.”
Dave Amerson, NeoTract’s CEO, also spoke of how the study will advance the understanding of the benefits of the UroLift System. “We are thrilled that the UroLift System has improved quality of life for thousands, and we look forward to bringing this innovative therapy to even more patients,” he said in the release.
Eligible men, age 50 or older, interested in participating in the trial can obtain more information through clinicaltrials.gov or by calling (650) 739-5570.