29 research outputs found
Recommended from our members
Attributes of Society of Genitourinary Reconstructive Surgeons Fellows and Early Career Trajectory of the Recent Graduates
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 naive 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
Recommended from our members
Attributes of Society of Genitourinary Reconstructive Surgeons Fellows and Early Career Trajectory of the Recent Graduates
Evaluation of Salvage Male Transobturator Sling Placement Following Recurrent Stress Urinary Incontinence After Failed Transobturator Sling
Extended Outcomes in the Treatment of Male Stress Urinary Incontinence With a Transobturator Sling
Recommended from our members
Evaluation of augmented reality technology in global urologic surgery.
BACKGROUND: The COVID-19 pandemic drastically reduced opportunities for surgical skill sharing between high-income and low to middle-income countries. Augmented reality (AR) technology allows mentors in one country to virtually train a mentee in another country during surgical cases without international travel. We hypothesize that AR technology is an effective live surgical training and mentorship modality. METHODS: Three senior urologic surgeons in the US and UK worked with four urologic surgeon trainees across the continent of Africa using AR systems. Trainers and trainees individually completed post-operative questionnaires evaluating their experience. RESULTS: Trainees rated the quality of virtual training as equivalent to in-person training in 83% of cases (N = 5 of 6 responses). Trainers reported the technologys visual quality as acceptable in 67% of cases (N = 12 of 18 responses). The audiovisual capabilities of the technology had a high impact in the majority of the cases. CONCLUSION: AR technology can effectively facilitate surgical training when in-person training is limited or unavailable