Additional assessments included PSA, creatinine measurement and transrectal ultrasound. There was a 42% improvement at 2 years in I-PSS from 21.8 ± 5.3 to 12.6 ± 7.2 (p <0.001) and 30% improvement in peak flow from 7.4 ± 2.2 to 10.3 ± 4.1 (p = 0.006). There was no significant change in PVR (baseline 54 ± 68 and followup 89 ± 104, p = 0.3). About half of the patients did not require a catheter postoperatively but of those who did, the catheter was removed the next day in three-quarters. In addition, there were no reports of anejaculation or retrograde
ejaculation. Erectile function was measured by SHIM (Sexual Health Inventory for Men) and was slightly INCB018424 improved from baseline. The most common side effects were irritative MS-275 price symptoms and hematuria which resolved within the first few weeks. A multinational evaluation of UroLift was conducted across 7 centers in 5 countries.5 Adverse events were mild to moderate, and most commonly were dysuria (25%), hematuria (16%) and urgency (10%) of short
durations. Three cases each of retention, urinary tract infection and orchitis were treated routinely and resolved. Furthermore, a sham study was performed in the U.S. on 206 men, of whom 144 underwent the procedure and 66 underwent a sham procedure. The procedure was done with the subjects under local anesthesia with oral sedation. At 1 year improvement in I-PSS was 10.9 (p <0.001) and improvement
in Qmax was 4.4 (p <0.001), with little change in erectile and ejaculatory function. The UroLift system received de novo approval from the United States Food and Drug Administration in Fall 2013, making it the first permanent approved implant to relieve symptoms due to urinary outflow obstruction secondary to BPH in men 50 years old or older.7 These initial data seem promising as we await the results of the multinational randomized trial comparing traditional electrosurgical transurethral resection of the prostate and the PUL procedure. Our initial 17-DMAG (Alvespimycin) HCl experience has been consistent with the published data, yet we do have concerns about its widespread applicability given potential issues with anesthesia and reimbursement. The UroLift system does require physician education to help with easy insertion and reproducibility. Furthermore, the device requires rigid cystoscopy in an awake male, which itself is a challenge. If these challenges are successfully met, PUL could be a useful tool in the armamentarium of urologists treating BPH. “
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