Temporary implant treats lower urinary symptoms

NEW YORK - A temporary implant made of nickel-titanium alloy, or nitinol, effectively treated symptoms of benign prostatic hyperplasia in its first trial in humans, a one-year follow-up study shows.

"In my experience the implantable nitinol device has demonstrated good results in terms of feasibility, safety, and efficacy," study investigator Dr. Francesco Porpiglia of the University of Turin, Italy, told Reuters Health by email.

Little training is required to implant the device, and application and removal "are very easy," he said.

In 32 men with lower urinary tract symptoms (LUTS) at San Luigi Gonzaga Hospital in Turin, researchers implanted the device (iTIND, Medi-Tate) under light intravenous sedation, along with antibiotic prophylaxis, with the device preloaded on a dedicated delivery system.

The device - 50 mm long, with a diameter of 33 mm - is designed to span the length of the prostatic urethra. It's delivered into the bladder through a cytoscope sheath, then manipulated until the anchoring leaflet is positioned at six o'clock distal to the bladder neck and the device is secure within the bladder neck and the prostatic urethra. Then the bladder is emptied and the cytoscope removed.

"Unlike other minimally invasive procedures, the surgeon has direct visualization of the device throughout the procedure," the authors wrote online March 7 in BJU International.

The average patient was about 70, mildly overweight, and with an average baseline International Prostate Symptom Score at the upper end of moderately symptomatic. All had been taking alpha-blockers.

In all cases, devices were implanted successfully and without intraoperative complications, the authors reported.

The median operative time was 5.8 minutes. For the first 20 procedures, patients stayed a median of one day in the hospital, while patients in the remaining procedures were discharged on the same day as the procedure. No one required readmission prior to removal of a device.

Four patients overall had early complications, including urinary retention and prostatic abscess. One patient had transient incontinence a day after the procedure; the device was removed immediately. Remaining devices were removed five days after the procedures in an outpatient clinic.

After 12 months, the median IPSS score was 9 (vs 19 at baseline, on a scale of 0 to 35, with higher numbers being worse), the quality of life score was 1 (vs 3 at baseline, on a scale of 0 to 6, with higher numbers being worse), and the mean urinary flow rate was 11.9 mL/s (vs 7.6 mL/s at baseline). No patients at that time required any medical therapy for benign prostatic hyperplasia.

Dr. Porpiglia has been working with the device for about five years and is now working on a second study involving more patients, he said.

"The first device tested was minimally modified to be more compliant to the bladder neck. The device is now more comfortable and could be useful also for patients with a medium prostate enlargement, not only in patients with low urinary tract symptoms but with small prostate size," he said.

The reduction of symptoms perception by patients after this procedure - at least for one-year study follow-up - makes the implantable nitinol device an effective minimally invasive option for treatment of prostate enlargement, he said.

The iTIND is the flagship product of Medi-Tate in Hertzliya Pituach, Israel, according to Vanessa Malka, chief operating officer of the company.

The device is approved in Europe and Candada, and the company is seeking regulatory approval in China, Korea, Brazil, Russia, and South Africa. A pivotal trial in the U.S. will begin by July, Malka said.

SOURCE: http://bit.ly/1BPZLbf

BJU Int 2015.

References: Reuters Health
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