User perception of a new hydrophilic-coated male urinary catheter for intermittent use.

AIMS: This study investigated user perception and adherence related to a hydrophilic-coated urinary catheter (LoFric® Origo™), available for male patients who practice intermittent catheterization. DESIGN: The study had a prospective observational design, including patients from 19 European hospitals. METHODS: A total of 416 patients were eligible for the study; 179 experienced catheter users and 237 de novo. Two questionnaires were filled out, one describing background data and a second, 8 weeks later, evaluating catheter features. RESULTS: The response rate for the second questionnaire was 88% (365 patients). Patients evaluating the new catheter showed a general satisfaction rate of 81% and 72% kept using it. The hygienic grip of the catheter was appreciated by 85% and the foldable feature by 67%. The results show that convenience, ease of use, and hygienic factors are patient-preferred features for a urinary catheter. These factors were confirmed for the evaluated hydrophilic-coated catheter.

The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial.

PURPOSE: In this double-blind, randomized study we compared the efficacy and safety of onabotulinumtoxinA or solifenacin vs placebo in patients with overactive bladder who had urinary incontinence and an inadequate response to or were intolerant of an anticholinergic. Post hoc analysis was done to compare the effects of onabotulinumtoxinA vs solifenacin. MATERIALS AND METHODS: Solifenacin naïve patients were randomized to onabotulinumtoxinA 100 U, solifenacin 5 mg, (which could escalate to 10 mg at week 6 according to predefined criteria) or placebo. Patients could request treatment 2 (open label onabotulinumtoxinA) after fulfilling prespecified criteria. End points included a change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a 100% reduction (dry) in the number of incontinence episodes per day as co-primaries, other urinary symptoms and quality of life, all at week 12, and adverse events. RESULTS: The change from baseline in incontinence episodes per day was significantly greater with onabotulinumtoxinA or solifenacin vs placebo (-3.19 or -2.56, respectively, vs -1.33, both p <0.001). The incontinence reduction was significantly greater for onabotulinumtoxinA vs solifenacin (p = 0.022). At week 12, 33.8% (vs placebo p <0.001), 24.5% (vs placebo p = 0.028) and 11.7% of patients receiving onabotulinumtoxinA, solifenacin and placebo, respectively, were dry. After treatment 2, which was open label onabotulinumtoxinA, 43.2%, 37.6% and 41.9% of patients in the onabotulinumtoxinA, solifenacin and placebo groups, respectively, were dry. Significant improvements in other urinary symptoms and quality of life were observed for both active treatments. Urinary tract infection in 25.5% of cases and urinary retention in 6.9% were more common with onabotulinumtoxinA. CONCLUSIONS: The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.