Renal concentrating capacity was lowest in groups 1 and 3 (939 +/- 147 mOsm./kg. controls, 856 +/- 158 group 1, 1,073 +/- 71 group 2, 762 +/- 119 group 3 and 970 +/- 146 group 4; p <0.01), whereas they had high urinary output (15.4 +/- 73.4 ml./kg. per hour controls, 22.2 +/- 10.2 group 1, 13.5 +/- 4.3 group 2, 21.5 +/- 11.2 group 3 and 15.0 +/- 6.9 group 4; p <0.01). Forced functional bladder capacity of that expected for age was lowest in groups 2 to 4 (107 +/- 43% controls, 88 +/- 43 group 1, 71 +/- 25 group 2, 68 +/- 22 group 3 and 59 +/- 22 group 4; p <0.01).
Overactive bladder (OAB) is a medical syndrome defined by symptoms of urgency, with or without urge urinary incontinence (any involuntary loss of urine), usually with frequency and nocturia. Although anticholinergic agents have been the first-line treatment for OAB for many years, the efficacious pharmacologic management of this condition has been compromised by concerns regarding tolerability. Flavoxate was the first anticholinergic and antispasmodic agent approved by the Food and Drug Administration (FDA) to treat symptoms of OAB but is not routinely used today since newer agents are more effective. The more recent drugs, oxybutynin and tolterodine, have appeared to be equally efficacious in treating the symptoms of OAB in clinical trials; however, tolterodine has proven to be better tolerated with fewer adverse effects. In 2004, the FDA approved the three newest agents for the class: darifenacin, solifenacin, and trospium. Compared with oxybutynin and tolterodine, these agents have a more favorable side effect profile, which can enhance tolerability and patient compliance. Side effects are reduced in part because of the drugs' greater tissue selectivity for inhibiting the bladder muscle contraction over other anticholinergic receptors in the body. In recent clinical trials, darifenacin, solifenacin, and trospium have shown superiority to placebo and efficacy comparable to that of oxybutynin and tolterodine.
The reactivity of the urinary bladder smooth muscle was estimated in vitro using organ chambers. The smooth muscle strips were prepared from guinea pig urinary bladders and aerated under the tension in Krebs-Henseleit's solution in the organ bath. The cumulative concentration-response curves to acetylcholine (10(-8)-10(-3) mol.l(-1)) were constructed before and after 15 minute incubation with propantheline in concentration of 10(-6), 10(-5), 10(-4), and 10(-3) mol.l(-1).
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Oral anticholinergic drugs are widely used to treat detrusor overactivity, but they are ineffective in some patients or cause systemic side effects such as blurred vision or dry mouth. As an alternative, topical therapy strategies have been suggested to achieve a profound inhibition of the overactive detrusor and to avoid high systemic drug levels. Currently available intravesical treatment options either act on the afferent arc of the reflex such as local anaesthetics or vanilloids or on the efferent cholinergic transmission to the detrusor muscle such as intravesical oxybutynin or botulinum toxin. Although an established and effective therapy, intravesical oxybutynin is not widely used. Evidence for clinical significance of intravesical atropine and local anaesthetic is missing. Intravesical capsaicin has been shown to improve clinical and urodynamic parameters, but cause pain in some patients. The intravesical instillation of resiniferatoxin and the injection of botulinum-A toxin into the detrusor muscle are promising new options; however, randomised placebo-controlled studies to prove their safety and efficacy are still missing.
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Pharmaceutical outcomes research with a health-care provider perspective was conducted on a California Medicaid (Medi-Cal) chronic OAB/UI population. The primary end point was medication possession ratio (MPR), which was used to measure refill adherence. Secondary end points measuring persistence patterns included discontinuation of OAB drug therapy (medication-uncovered interval > 30 days) and time to discontinuation (period from the index date until the first discontinuation date). Significant factors on nonpersistence were found by using a Cox Proportional Hazards model. Factors contributing to nonadherence (MPR < 0.8) and the relationship between OAB/UI comorbidity events and persistence were examined by logistic regressions.
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Overactive bladder is associated with symptoms of urgency, with or without urge incontinence, usually with daytime frequency and nocturia in the absence of local pathological factors. Muscarinic receptor antagonists (antimuscarinics) are the first-line pharmacotherapy. Tolterodine, a competitive, nonselective antimuscarinic specifically developed for the treatment of overactive bladder, demonstrated tissue selectivity for the bladder over the parotid gland in an animal model. As of March 5, 2003, the immediate-release (IR) formulation had been approved in 72 countries and the extended-release (ER) formulation had been approved in 28 countries, and tolterodine had been administered to 5 million patients. This review evaluates the benefit-risk profile of tolterodine in the treatment of adults with overactive bladder, summarising clinical trial and postmarketing surveillance data. Tolterodine has been found to significantly reduce micturition frequency, urgency perception and the number of episodes of urge incontinence and increase the volume voided per micturition. Dry mouth, an antimuscarinic class effect, is the most commonly reported adverse effect but is mostly mild to moderate in severity. Serious adverse effects are reported infrequently. Based on summary and review of postmarketing surveillance and clinical trial safety data received by the market authorization holder and contained in the Periodic Safety Update Reports for tolterodine, several monitored serious events of the gastrointestinal tract (e.g. ileus or haemorrhage), nervous system (e.g. syncope, convulsions and memory disorders) and cardiovascular system (e.g. ventricular arrhythmia, atrial fibrillation, palpitations, bradycardia, transient ischaemic attacks and hypertension) were not considered related to tolterodine. QT or corrected QT (QTc) prolongation was not observed in any of the five cases of verified ventricular arrhythmia in patients administered tolterodine; there is insufficient evidence to indicate that tolterodine causes ventricular arrhythmia or extrasystoles or any specific type of cardiac rhythm abnormality. The safety profile of tolterodine is similar in patients aged > or =65 years and in younger adults. Clinically relevant drug interactions are limited to cytochrome P450 3A4 inhibitors, such as ketoconazole, and co-administration with such agents warrants a tolterodine dosage decrease. In addition, tolterodine IR 2mg twice daily is similar in efficacy to oxybutynin IR 5mg three times daily, and tolterodine ER 4 mg once daily is similar in efficacy to oxybutynin ER 10mg once daily. Dry mouth occurred less frequently with tolterodine than oxybutynin, and moderate to severe dry mouth occurred more than three times less frequently. Based on the low frequency of adverse events, the absence of unexpected adverse events and the very low frequency of serious adverse events, we conclude that tolterodine is a well tolerated treatment for overactive bladder in adults, in whom it should be considered as first-line therapy.
There were no intraoperative or postoperative complications, nor were there any serious side effects attributable to any of the intravesically instilled agents. There was a statistically significant decrease in stent-related discomfort at the 1-hour time point in the group of patients who received intravesical ketorolac compared with the control group.
• The number of patients prescribed each antimuscarinic drug varied from 23 for darifenacin to 1758 for tolterodine ER. • The longest mean persistence was reported for solifenacin (187 days versus 77-157 days for the other treatments). • At 3 months, the proportions of patients still on their original treatment were: solifenacin 58%, darifenacin 52%, tolterodine ER 47%, propiverine 47%, tolterodine IR 46%, oxybutynin ER 44%, trospium 42%, oxybutynin IR 40%, flavoxate 28%. • At 12 months, the proportions of patients still on their original treatment were: solifenacin 35%, tolterodine ER 28%, propiverine 27%, oxybutynin ER 26%, trospium 26%, tolterodine IR 24%, oxybutynin IR 22%, darifenacin 17%, flavoxate 14%. • In a sub-analysis stratified by age, patients aged ≥ 60 years were more likely to persist with prescribed therapy over the 12-month period than those aged <60 years.