Efficacy and safety of an alternative onabotulinumtoxinA injection paradigm for refractory overactive bladder.

AIMS: In studies utilizing a 20-injection-site paradigm of onabotulinumtoxinA treatment for overactive bladder (OAB), some patients performed clean intermittent catheterization (CIC). An alternative injection paradigm of fewer injections targeting the lower bladder may reduce the need for CIC by maintaining upper bladder function. This study evaluated the efficacy and safety of an unapproved alternative 10-injection-site paradigm targeting the lower bladder. METHODS: In this phase 4, double-blind, parallel-group study, patients with OAB and urinary incontinence (UI) for ≥6 months with ≥3 episodes of urinary urgency incontinence (no more than 1 UI-free day) and ≥8 micturitions per day over 3 days during screening were randomized 2:1 to onabotulinumtoxinA 100 U or placebo injected at 10 sites in the lower bladder. RESULTS: Of 120 patients, 78 in the onabotulinumtoxinA group and 39 in the placebo group had efficacy assessments. In the double-blind phase, mean change from baseline at week 12 in daily frequency of UI episodes was greater with onabotulinumtoxinA (-2.9) versus placebo (-0.3) (least squares mean difference [LSMD]: -2.99, p < 0.0001). Achievement of 100% (odds ratio [OR]: 6.15 [95% confidence interval, CI: 0.75-50.37]), ≥75% (OR: 7.25 [2.00-26.29]), and ≥50% improvement (OR: 4.79 [1.87-12.28]) from baseline in UI episodes was greater with onabotulinumtoxinA versus placebo. Reductions from baseline in the daily average number of micturitions (LSMD: -2.24, p < 0.0001), nocturia (LSMD: -0.71, p = 0.0004), and urgency (LSMD: -2.56, p < 0.0001) were greater with onabotulinumtoxinA than with placebo. Treatment benefit was improved or greatly improved in the onabotulinumtoxinA group (74.0% of patients) versus placebo (17.6%) (OR: 13.03 [95% CI: 3.23-52.57]). Mean change from baseline in Incontinence Quality of Life score was greater with onabotulinumtoxinA versus placebo (LSMD: 24.2, p = 0.0012). Two of 78 (2.6%) patients in the onabotulinumtoxinA group used CIC during the double-blind period; no females used CIC during the double-blind period. Commonly reported adverse events (≥5%) were urinary tract infection (UTI), dysuria, and productive cough for both groups; rate of UTI was higher with onabotulinumtoxinA versus placebo. CONCLUSION: In patients treated with onabotulinumtoxinA for OAB with UI, an unapproved alternative injection paradigm targeting the lower bladder demonstrated efficacy over placebo, with a low incidence of CIC.

Urodynamics in a patient with Werdnig-Hoffman disease.

Werdnig-Hoffman Disease (WHD) is a rare type of spinal muscular atrophy which causes progressive deterioration of the lower motor neurons of the spinal cord and the brainstem. To our knowledge we report the first case of neurogenic bladder documented on urodynamic studies of a patient with WHD.

Urinary tract infection associated with ureteral stents in renal transplantation.

OBJECTIVES: In the mid 1980s, ureteral stents were used in renal transplantation when ureteral injury had occurred. Subsequently, it was shown that routine ureteral stent placement at the time of transplantation reduced urological complications. We carried out a chart review on renal transplant patients and noted which patients developed urinary tract infections (UTIs) with stents in place, and whether these infections ultimately affected transplant outcome. We sought to distinguish subgroups of patients who were more likely to develop infection and to identify the optimum time for stent removal. PATIENTS AND METHODS: We performed a retrospective chart review of 213 patients who underwent renal transplantation in 1994 and 1995. Adequate follow-up information was available on 167 patients with intraoperative stent placement. Of these 167 patients, 4 patients expired and 8 required transplant nephrectomy due to complications unrelated to the stent. RESULTS: In total, 35 patients (22.6%) developed a post-operative UTI. One infection occurred during the first week following transplant, 3 developed within 2 weeks, and importantly, the remaining 32 infections occurred more than 2 weeks after transplant. An increase in infections in diabetics (25.7%) as compared to other transplant recipients (20.2%) was noted. Patients with cadaveric renal transplants are also at higher risk of UTI (24%) compared to those with living related donors (15%). CONCLUSION: The use of ureteral stents is safe, but is associated with a UTI rate of 22.6%. To reduce infection rates, we recommend stent removal within 14 days and earlier if possible, particularly in diabetic patients who have received a cadaveric renal transplant.