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.

We performed serial pulmonary function measurements in 28 patients with thermal injury in order to investigate the pulmonary effects of smoke inhalation, small and large surface burns, and the combination of burn and inhalation. Patients were studied at postinjury time intervals of 9.0 +/- 0.6 (M +/- SEM), 22.0 +/- 1.6, 37.3 +/- 2.2, 58.4 +/- 2.5 hours; 11.5 +/- 0.6 days; 1.1 +/- 0.1 and 5.0 +/- 0.5 months. Spirometry was found to be as useful as more sophisticated measurements in the examination of both burn and smoke inhalation groups. Smoke inhalation caused severe airway obstruction 9 h after exposure. Patients with surface burn resuscitated with 4 ml of Ringer's lactate/per cent surface area burn/kilogram developed a significant restrictive defect over the first 58 h, despite normal pulmonary capillary wedge pressures. The restrictive defect in these patients correlated with the size of surface and chest burn, degree of fluid retention, and reduction in colloid osmotic pressure. Surface burn and smoke inhalation caused the greatest deterioration in pulmonary function. These defects gradually resolved during the period of observation.

In this phase three trial, the Vesair intravesical balloon achieved 3 month primary and secondary endpoints both objectively and subjectively.

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Purpose:The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure.Materials and Methods:Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments.Results:A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%).Conclusions:Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.