used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF <14 and ≥ 14). Analysis of covariance was used to analyse I-QOL scores.
RESULTSThe mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of ≥ 14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine ( P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial.
CONCLUSIONSThese results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America.
KEYWORDSstress urinary incontinence, quality of life, duloxetine hydrochloride, serotonin, noradrenaline
OBJECTIVESTo further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions,
In this study treatment with solifenacin 5 mg and 10 mg once daily significantly improved all the major symptoms of overactive bladder including frequency, urgency and incontinence. Solifenacin 10 mg also decreased the frequency of nocturia. Solifenacin therapy was associated with a favorable tolerability profile and a low incidence of dry mouth, especially at the 5 mg starting dose.
Tolterodine did not adversely affect urinary function in men with OAB and BOO. Urinary flow rate was unaltered, and there was no evidence of clinically meaningful changes in voiding pressure and PVR or urinary retention. Tolterodine was well tolerated. These results suggest that antimuscarinics can be safely administered in men with BOO.
1 We investigated muscarinic receptors in the detrusor and mucosa of the human bladder body. Radioligand-binding studies with [ 5 The presence of a high density of mainly M 2 muscarinic receptors in the mucosa appears to be a novel finding and raises the question of their physiological significance and the source of their endogenous ligand. 6 There was a negative correlation of receptor number (B max ) with age in detrusor muscle from male patients (P ¼ 0.02). Quantitative competitive RT-PCR demonstrated a selective age-related decrease in mRNA for muscarinic M 3 but not M 2 receptors, in both male (Po0.0001) and female (P ¼ 0.019) detrusor. These findings correspond with reports of decreased detrusor contractility with ageing.
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