The Optilume ® Drug Coated Balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. Materials and Methods: Eligibility criteria were: adult men with anterior strictures ≤12F in diameter and ≤3cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11, and maximum flow rate <15 mL/sec. 127 subjects were enrolled at 22 sites. The primary study endpoint was anatomic success (≥14F by cystoscopy or calibration) at 6 months. Key secondary endpoints included freedom from repeat treatment, International Prostatic Symptom Score (IPSS), and peak flow rate (Qmax). The primary safety endpoint included freedom from serious device or procedure related complications. Results: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7cm. Anatomic success for Optilume DCB was significantly higher than Control at 6 months (75% vs 27%, p<0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequently adverse events included urinary tract infection, postprocedural hematuria, and dysuria. Conclusions: The results of this randomized controlled trial support that Optilume is safe and superior to standard DVIU/dilation for the treatment of recurrent anterior urethral strictures <3cm in length. The Optilume DCB may serve as an important alternative for men that have had an unsuccessful DVIU/dilation but want to avoid or delay urethroplasty.
Implementing a decreased fluoroscopy protocol during percutaneous nephrostolithotomy resulted in an 80.9% reduction in fluoroscopy time while maintaining success rates, operative times and complications similar to those of the conventional technique. Adopting this reduced fluoroscopy protocol safely decreased radiation exposure to patients, surgeons and operating room staff during percutaneous nephrostolithotomy.
We performed a retrospective review of an outbreak of Salmonella gastroenteritis that occurred in a community nursing home in 1987. Forty-four of 199 residents had a diarrheal illness; Salmonella heidelberg was isolated from the stool in 19 cases. Although the distribution of cases suggested a common source for the outbreak, no common source of infection could be demonstrated, despite extensive investigation. The clinical presentation of symptomatic individuals ranged from mild diarrhea to a severe gastrointestinal illness, and 26% of symptomatic, culture-positive patients required hospitalization. The median duration of pathogen excretion during convalescence in untreated residents was six weeks, but six patients who were treated with antibiotics shed S. heidelberg for a median duration of 14.5 weeks. We conclude that (1) the clinical spectrum of Salmonella gastroenteritis in nursing-home patients is variable, ranging from mild to severe illness; and (2) nursing-home Salmonella outbreaks impose a high economic burden because of expense of epidemiologic investigation, prolonged isolation measures, hospitalization for severely ill residents, and potential institutional closure.
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