291 research outputs found
A 7-year follow-up of sacral anterior root stimulation for bladder control in patients with a spinal cord injury: quality of life and users' experiences\ud
Study design: Cross-sectional descriptive study.\ud
\ud
Objectives: To assess long-term effects and quality of life (QoL) of using sacral anterior root stimulation (SARS) in spinal cord injured patients.\ud
\ud
Setting: Neurosurgical and Urological Departments of a large teaching hospital and a large rehabilitation centre in the Netherlands.\ud
\ud
Methods: In all, 42 patients with complete spinal cord injury (SCI) implanted between 1987 and 2000 were included. A questionnaire was constructed to determine complications, technical failures and personal experiences of the patients. The Qualiveen questionnaire was used and the outcome was compared with data obtained from a reference group of 400 SCI patients with neurogenic bladder problems not using the bladder controller. The Qualiveen questionnaire measures disease-specific aspects in four domains with respect to limitations, constraints, fears and feelings and general QoL aspects, suitable for use in SCI patients with urinary disorders.\ud
\ud
Results: The results of 37 patients are presented. Our results with the bladder controller with respect to medical and technical complications and infection rates are similar to the results presented by others. From users' experiences, the most important advantages reported were a decreased infection rate (68%), improved social life (54%) and continence (54%). Comparison of the obtained results of our patient group with the Qualiveen questionnaire with a reference group not using the bladder controller indicates that the specific impact of urinary disorders in the four domains on QoL is reduced and that general QoL is improved.\ud
\ud
Conclusion: SARS is effective and safe for neurogenic bladder management in patients with complete SCI. Users' experiences are positive. Furthermore, this therapy seems to reduce the effects of urinary-disorder-specific QoL aspects, and to increase the QoL in general\u
Onset of action of the beta 3-adrenoceptor agonist, mirabegron, in Phase II and III clinical trials in patients with overactive bladder
Purpose Long-term persistence with pharmacotherapy for
overactive bladder (OAB) requires a drug with an early onset
of action and good efficacy and tolerability profile. Although
antimuscarinics improve OAB symptoms within 1–2 weeks
of initiating treatment, adherence after 3 months is relatively
poor due to bothersome side effects (e.g., dry mouth and
constipation). Mirabegron, a b3-adrenoceptor agonist, has
demonstrated significant improvements in key symptoms of
OAB and good tolerability after 12 weeks in Phase III studies.
Methods This was a prespecified pooled analysis of three
randomized, double-blind, placebo-controlled, 12-week
studies, and a Phase II study, to evaluate efficacy and tolerability
of mirabegron 25 and 50 mg versus placebo. The
main efficacy endpoints were change from baseline to
week 1 (Phase II only), week 4, and final visit in mean
number of incontinence episodes/24 h, micturitions/24 h,
and mean volume voided/micturition (MVV).
Results A significant benefit for mirabegron 25 and 50 mg
versus placebo was evident at the first assessment point,
4 weeks after initiation of therapy, in Phase III studies for
incontinence, micturitions, and MVV. The earliest measured
benefit was after 1 week, in the Phase II study. Quality-of-life
parameters also significantly improved with mirabegron 25
and 50 mg as early as week 4. Significant benefits continued
throughout the studies. Mirabegron was well tolerated.
Conclusions The early onset of action and good overall
efficacy and tolerability balance that mirabegron offers
may lead to high rates of persistence with mirabegron in
the long-term treatment of OAB
Finding long cycles in graphs
We analyze the problem of discovering long cycles inside a graph. We propose
and test two algorithms for this task. The first one is based on recent
advances in statistical mechanics and relies on a message passing procedure.
The second follows a more standard Monte Carlo Markov Chain strategy. Special
attention is devoted to Hamiltonian cycles of (non-regular) random graphs of
minimal connectivity equal to three
A phase II dose-ranging study of mirabegron in patients with overactive bladder
Introduction and hypothesis Mirabegron is a potent and
selective β3-adrenoceptor agonist that may represent an
alternative treatment option in place of antimuscarinics for
patients with overactive bladder.
Methods Patients completed a single-blinded, 2-week placebo
run-in period followed by 12 weeks of randomized
(n=928) double-blinded treatment with mirabegron oral
controlled absorption system (OCAS) 25, 50, 100, or
200 mg once-daily (QD), placebo or tolterodine extended
release (ER) 4 mg QD. The primary endpoint was
change from baseline to end-of-treatment in mean number
of micturition episodes/24 h. Secondary endpoints
included changes in mean volume voided per micturition;
mean number of urinary incontinence, urgency urinary
incontinence, and urgency episodes/24 h; severity of urgency;
nocturia; and quality of life measures. Safety
parameters included vital signs, adverse events, laboratory
tests, electrocardiogram measurements and post-void residual
volume.
Results Mirabegron 25, 50, 100, and 200 mg resulted in dosedependent
reductions (improvements) from baseline to end-oftreatment
in micturition frequency of 1.9, 2.1, 2.1, and 2.2
micturitions/24 h respectively, versus 1.4 micturitions/24 h with
placebo (p≤0.05 for the mirabegron 50-, 100-, and 200-mg
comparisons). There was a statistically significant improvement
with mirabegron compared with placebo for most secondary
endpoints including quality of life variables. While there was a
significant (p<0.05) increase from baseline in pulse rate in the
mirabegron 100-mg and 200-mg groups, this was not associated
with an increased incidence of cardiovascular adverse events.
Conclusions The favorable efficacy and tolerability of mirabegron
in this phase II dose-finding study has led to its successful
advancement into a phase III clinical development program
Incidence of urinary retention during treatment with single tablet combinations of solifenacin+tamsulosin OCAS™ for up to 1 year in adult men with both storage and voiding LUTS: a subanalysis of the NEPTUNE/NEPTUNE II randomized controlled studies
Introduction: The emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs. Materials and methods: In NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months. Results: Across both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%-1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%-1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/ UR events occurred within 4 months of treatment initiation. Conclusions: FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS
- …