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PubMed2003

A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder.

This study evaluated the efficacy and tolerability of new extended-release (ER) tolterodine for the treatment of overactive bladder in women. In this subpopulation analysis of a double-blind multicenter trial, 1235 female patients were randomized to oral therapy with tolterodine ER 4 mg once daily (n=417), tolterodine IR 2 mg twice daily (n=408) or placebo (n=410) for 12 weeks. Both formulations reduced the mean number of urge incontinence episodes per week (both P=0.001 vs placebo); tolterodine ER was more effective than tolterodine IR (P=0.036). Both formulations significantly improved all other micturition chart variables compared to placebo. Dry mouth was the most common adverse event. There were no safety concerns. Toltrodine ER 4 mg once daily is effective and well tolerated in the treatment of women with overactive bladder, and reduces urge incontinence episodes more than the existing IR twice-daily formulation.

Benzhydryl Compounds↗

PubMed2004

Validation of a simple patient questionnaire to assist self-detection of overactive bladder. A study in general practice.

OBJECTIVE: To develop and validate a simple patient questionnaire for the detection of overactive bladder (OAB). DESIGN: An open, non-randomized multicentre study. SETTING: A pilot study (n = 133) was conducted to bring forward five questions from initially 14 questions, for detection of OAB. These five questions were subject to further validation in the main study (n =520). SUBJECTS: 531 adults responding to a newspaper advertisement regarding symptoms of OAB and patients seeing a physician for other reasons were attending 28 general practitioners. MAIN OUTCOME MEASURES: Agreement rate, sensitivity, and specificity. RESULTS: The agreement rate between the patients' own diagnosis based on the patient questionnaire, and the physicians' diagnosis based on medical history, urine analysis, and micturition chart, was 0.78 (kappa =0.89). Sensitivity and specificity were 0.98 and 0.90, respectively. CONCLUSION: The validated questionnaire may become a useful tool to decide whether a patient has overactive bladder. The questionnaire corresponds well with the physicians' diagnosis.

Adult↗

PubMed2006

Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study.

OBJECTIVE: Estimate the prevalence of urinary incontinence (UI), overactive bladder (OAB), and other lower urinary tract symptoms (LUTS) among men and women in five countries using the 2002 International Continence Society (ICS) definitions. METHODS: This population-based, cross-sectional survey was conducted between April and December 2005 in Canada, Germany, Italy, Sweden, and the United Kingdom using computer-assisted telephone interviews. A random sample of men and women aged >/= 18 yr residing in the five countries and who were representative of the general populations in these countries was selected. Using 2002 ICS definitions, the prevalence estimates of storage, voiding, and postmicturition LUTS were calculated. Data were stratified by country, age cohort, and gender. RESULTS: A total of 19,165 individuals agreed to participate; 64.3% reported at least one LUTS. Nocturia was the most prevalent LUTS (men, 48.6%; women, 54.5%). The prevalence of storage LUTS (men, 51.3%; women, 59.2%) was greater than that for voiding (men, 25.7%; women, 19.5%) and postmicturition (men, 16.9%; women, 14.2%) symptoms combined. The overall prevalence of OAB was 11.8%; rates were similar in men and women and increased with age. OAB was more prevalent than all types of UI combined (9.4%). CONCLUSIONS: The EPIC study is the largest population-based survey to assess prevalence rates of OAB, UI, and other LUTS in five countries. To date, this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions. The results indicate that these symptoms are highly prevalent in the countries surveyed.

Adolescent↗

PubMed2006

Overactive bladder syndrome among community-dwelling adults in Taiwan: prevalence, correlates, perception, and treatment seeking.

PURPOSE: We investigated the prevalence, correlates, perception of overactive bladder syndrome (OAB) and doctor-consultation behavior among community adults. SUBJECTS AND METHODS: This urological survey was part of a government-supported health utilization project conducted in Matsu, Taiwan. Participants (n = 1,827) completed a questionnaire collecting information on OAB, which was defined as urgency with either frequency or nocturia. RESULTS: The age-adjusted prevalence of OAB was 16.9%, including 4.5% with urge incontinence. Age (p = 0.002), diabetes (p = 0.03), and benign prostatic hyperplasia (p < 0.001) in men, whereas diabetes (p = 0.01), hyperlipidemia (p = 0.03), stress incontinence (p < 0.001), and recurrent lower urinary tract infections (p = 0.02) in women were factors independently associated with OAB. Most people with OAB (69.0%) perceived little bother; only 13.0% had consulted doctors for this problem. CONCLUSION: Symptoms related to OAB are common among community-dwelling adults, yet most perceive it as a minor problem. Our results identify several factors that are significantly associated with OAB.

Adult↗

PubMed1999

Effects of nifedipine on bladder overactivity in rats with cerebral infarction.

PURPOSE: Our objective was to evaluate the effect of the calcium (Ca2+) channel blocking agent nifedipine on bladder overactivity induced by middle cerebral artery (MCA) occlusion and determine its site of action. MATERIALS AND METHODS: Seven days after implantation of a bladder catheter, a cannula for intracerebroventricular and intrathecal administration was implanted and the left MCA was occluded with 4-0 monofilament nylon thread in male SD rats. Twenty-four hours after the induction of cerebral ischemia, saline was infused into the bladder at a constant rate (200 microL/min.) and cystometrogram was measured in conscious state. Nifedipine was administered intracerebroventricularly (5 microL) or intrathecally (20 microL) at graded doses (0.15 ng.-0.15 microg., 0.15 microg. -1.5 microg., respectively). RESULTS: Bladder capacity in conscious rats was significantly reduced after the left MCA occlusion. Intracerebroventricular administration of nifedipine significantly increased bladder capacity in cerebral infarcted rats but not in sham operated rats. Furthermore there was no significant difference in bladder capacity between before and after intrathecal administration of nifedipine in cerebral infarcted rats. CONCLUSION: These results show that Ca2+ channel blocking agents can operate especially on the supraspinal central nervous system rather than on the spinal system in rats with neurogenic bladder overactivity following cerebral infarction.

Animals↗

PubMed2004

The emerging role of solifenacin in the treatment of overactive bladder.

Although antimuscarinic drug therapy has been proven to be effective in the management of patients with symptoms of the overactive bladder syndrome, compliance with medication is often affected by the antimuscarinic adverse effects of dry mouth, constipation, somnolence and blurred vision. The development of bladder-selective M(3)-specific antagonists offers the possibility of increasing efficacy whilst minimising adverse effects. At present there are no M(3)-specific antagonists currently available although solifenacin and darifenacin are both under development and are due to be launched in 2004. The purpose of this article is to review the pharmacology and clinical trial data available for solifenacin, in addition to examining its role in the treatment of the overactive bladder syndrome.

Clinical Trials as Topic↗

PubMed2005

Advantages for transdermal over oral oxybutynin to treat overactive bladder: Muscarinic receptor binding, plasma drug concentration, and salivary secretion.

To clarify pharmacological usefulness of transdermal oxybutynin in the therapy of overactive bladder, we have characterized muscarinic receptor binding in rat tissues with measurement of plasma concentrations of oxybutynin and its metabolite N-desethyl-oxybutynin (DEOB) and salivation after transdermal oxybutynin compared with oral route. At 1 and 3 h after oral administration of oxybutynin, there was a significant increase in apparent dissociation constant (Kd) for specific [N-methyl-3H]scopolamine ([3H]NMS) binding in the rat bladder, submaxillary gland, heart, and colon compared with control values. Concomitantly, submaxillary gland and heart showed a significant decrease in maximal number of binding sites (Bmax) for [3H]NMS binding, which lasted until 24 h. Transdermal application of oxybutynin caused dose-dependent increases in Kd values for specific [3H]NMS binding in rat tissues. The increment of Kd values by transdermal oxybutynin was dependent on the application time. Plasma concentrations of oxybutynin and DEOB peaked at 1 h after oral oxybutynin. In contrast, plasma concentrations of oxybutynin increased slowly, depending on the transdermal application time of this drug until 12 h. Suppression of pilocarpine-induced salivation in rats due to transdermal oxybutynin was significantly weaker and more reversible than that by oral oxybutynin, which abolished salivary secretion. The present study has shown that transdermal oxybutynin binds significantly to rat bladder muscarinic receptors without producing both long-lasting occupation of exocrine receptors and cessation of cholinergic salivation evoked by oral oxybutynin. Thus, the present study provides further pharmacological basis for advantage of transdermal over oral oxybutynin in the therapy of overactive bladder.

Administration, Cutaneous↗

PubMed2005

Nocturnal polyuria in women with overactive bladder symptoms and nocturia.

OBJECTIVE: This study was undertaken to determine the prevalence of nocturnal polyuria in women complaining of nocturia and overactive bladder (OAB) symptoms and to identify clinical and health characteristics associated with nocturnal polyuria. STUDY DESIGN: Women presenting to a urogynecology clinic with complaints of nocturia and OAB symptoms were asked to participate. They completed a health characteristic summary, 3-day voiding diary, Nordic sleep questionnaire, urinary distress inventory (UDI), and a nocturia distress visual log (NDVL). The 24-hour urine production, nighttime urine volume, and maximum bladder capacity were calculated from the bladder diary. Nocturnal polyuria was defined as production of greater than 33% of the 24-hour urine volume during an 8-hour sleep period. A histogram was performed to analyze at what age the prevalence of nocturnal polyuria increased. Women were then divided by presence or absence of nocturnal polyuria and compared by the health and clinical characteristics. RESULTS: Fifty-five women met the qualifications and participated in the study. Average age of the cohort was 65.8 +/- 13.5 years. The risk of nocturnal polyuria increased with age 65 years or older (prevalence for age 65-74 = 0.86 [0.62-1.00]) and with white race. On the basis of the mean population values for UDI, NDVL, sleepiness scores, and insomnia scores, all women were bothered by their nocturia. Median number of nighttime voids, 24-hour urine production, maximum bladder capacity, nocturnal index, UDI, NDVL, sleepiness scores, and insomnia scores did not differ, based on presence or absence of nocturnal polyuria. CONCLUSION: Among women complaining of nocturia and overactive bladder symptoms, age 65 years or older and white race appear to be risk factors for nocturnal polyuria.

Aged↗

PubMed2006

Pharmacotherapy for overactive bladder: an evidence-based approach to selecting an antimuscarinic agent.

Multiple drugs are now available for the treatment of overactive bladder. Currently, the pharmacological approach is to deal with the problem at the neuromuscular junction by attempting to stop the activity of the neurotransmitter with antimuscarinic medications. This article reviews the positive and negative aspects of the agents that are currently available for use in the US. In randomised clinical trials, extended-release formulations of these agents appear as effective as the immediate-release formulations, but are associated with fewer adverse effects. Attempts to use entities that are muscarinic M(3) selective antimuscarinic agents have not significantly improved the efficacy, but have reduced the major adverse effect of excessively dry mouth. Dose escalation or titration is addressed to enhance efficacy further. None of these drugs appear to cause significant cardiac or CNS adverse events. This supports the continued use of these agents for overactive bladder symptomatology, as they appear to be effective in reducing symptoms and remain generally well tolerated.

Evidence-Based Medicine↗

PubMed2006

Prevalence and risk factors of overactive bladder syndrome in Fuzhou Chinese women.

AIMS: We randomly sampled a community-based, healthy population to evaluate the prevalence and associated risk factors of overactive bladder (OAB) syndrome by using the International Continence Society (ICS) definition. METHODS: We randomly sampled 6,066 women (3.0% of registered female residents aged 20 years and older in Fuzhou) and mailed Bristol Female Lower Urinary Tract Symptoms questionnaire for women self-completion. Women (4,684; 77.2%) with evaluable data were included in this study. RESULTS: The prevalence of OAB was 8.0% (n = 377), OAB(dry) 2.4% (n = 114), and OAB(wet) 5.6% (n = 263), hence 30% had OAB(dry) and 70% OAB(wet.) The prevalence of OAB and OAB(wet) demonstrated an significant increasing with advancing age (P < 0.01). A multiple logistic regression analysis showed menopause, parity >2, constipation, episiotomy, and higher BMI were potential risk factors for OAB, constipation increased the occurrence of OAB(dry). OAB(wet) was associated with menopause, parity >2, higher fetal birthweight, episiotomy, while cesarean delivery protected against the development of OAB(wet). CONCLUSIONS: The prevalence of OAB in chinese women is lower than that of most reports in Occidental women, and increases with advancing age. Many potential risk factors increase the occurrence of OAB.

Adult↗

PubMed2006

Intravesical botulinum type A toxin injection in patients with overactive bladder: Trigone versus trigone-sparing injection.

OBJECTIVE: Botulinum toxin type A (BTX-A) has been successfully used in the treatment of patients with overactive bladder (OAB) symptoms refractory to anticholinergic therapy, with most studies performing trigone-sparing detrusor injections. Increasing evidence suggest that sensory nerve dysfunction contributes to the pathophysiology of OAB and, for this reason, targeting the afferent innervation of the bladder trigone during injection may provide clinical benefit. MATERIALS AND METHODS: We conducted a pilot study to assess the benefit of trigonal-inclusion during BTX-A injection. A total of 40 patients with OAB refractory to anticholinergic treatment received trigone or trigone-sparing injection of BTX-A. Patients were evaluated using UDI-6 and IIQ-7 questionnaires prior to the BTX-A applications, at 3 weeks and 6 months after treatment. RESULTS: At 3-week follow-up, 15/24 (63%) and 10/16 (63%) patients showed improvement of symptoms in the trigone versus trigone-sparing groups, respectively. Combined 3-week UDI-6 and IIQ-7 scores improved from 37.3 prior to treatment to 27.4 (p < 0.05) and 35.5 to 27.2 (p < 0.05) in the trigone and trigone-sparing groups, respectively. Six-month follow-up demonstrated continued but diminished levels of symptom improvement when compared to pre-treatment and 3-week symptom scores. Improvement in symptom scores between the trigone and trigone-sparing groups was not significant. CONCLUSION: No significant difference in symptom score or treatment response was noted between the trigone and trigone-sparing groups. Further study using pre- and post-operative urodynamic study is needed to evaluate possible benefit to trigonal injection in a select sensory urgency cohort, and to assess for urodynamic improvement following trigonal injection.

Administration, Intravesical↗

PubMedDate not supplied

Overactive bladder patients and role of the pharmacist.

OBJECTIVES: To summarize the prevalence, quality of life (QOL) implications, cost of illness, and pharmacotherapy of overactive bladder (OAB), and to describe the pharmacist's role in the management of patients with OAB. DATA SOURCES: Articles published between 1990 and 2001 identified through a MEDLINE search using the terms overactive bladder, unstable bladder, urinary incontinence, prevalence, cost of illness, quality of life, drug therapy, pharmacist, and pharmacy in various combinations. STUDY SELECTION: All studies providing information on OAB or urinary incontinence were retrieved. DATA EXTRACTION: By the authors. DATA SYNTHESIS: Published prevalence and cost studies focus primarily on urinary incontinence, which is only one possible symptom of OAB. Reported prevalence rates of urge and mixed incontinence in the United States range from 3% to 8% and 5% to 37%, respectively, and the highest prevalence has been found in geriatric and psychogeriatric populations. Associated costs are substantial. Total costs of OAB in the United States were estimated to be $12.6 billion in 2000. Patients with OAB score lower than the general population in QOL assessments. All aspects of QOL can be compromised by OAB, as physical, social, occupational, domestic, and sexual activities are often limited in OAB patients. The pharmacist is instrumental in improving an individual's QOL through ensuring safe and effective treatment for OAB. Oxybutynin and tolterodine (Detrol-Pharmacia) have been the mainstays of pharmacotherapy for OAB, but frequent adverse effects (including dry mouth) often prevent patients from adhering to treatment. Tolterodine, now available in a new long-acting formulation, has been proven safe and efficacious in the treatment of OAB, with fewer adverse effects and better tolerability than existing agents. CONCLUSION: Pharmacists can play an active role in helping identify and recommending interventions for OAB that can ultimately improve an individual's QOL.

Cost of Illness↗

PubMed2002

Different responses to drugs against overactive bladder in detrusor muscle of pig, guinea pig and mouse.

Direct comparison of experimental data for drugs commonly used in the treatment of overactive bladder is difficult because of possible species differences. In this study, we compare the effects of atropine, propiverine, oxybutynin and tolterodine in strips of pig, guinea pig and mouse detrusor muscle. In the three species, we observed slight differences in potency of carbachol-induced biphasic contractile responses between the species (guinea pig>pig>mouse). Cumulative concentration-response curves for carbachol were shifted to the right by atropine, propiverine, oxybutynin and tolterodine. However, at higher concentrations of the latter three antagonists, the maximum response to carbachol was also reduced. Therefore, propiverine, oxybutynin and tolterodine must have additional pharmacological actions beyond competitive antagonism at muscarinic receptors. Electric field stimulation (30 Hz) of detrusor strips led to contraction amplitudes, which remained constant over time (210 min) in pig, decreased by 17+/-5% in guinea pig, and increased by 28+/-9% in mouse detrusor muscle. Electric field stimulation-evoked contractions were suppressed to 18% of pre-drug control by high concentrations of atropine (10 microM) in pig, but to a much lesser extent in guinea pig and mouse (to 46% and 70%, respectively). In all three species, a myogenic component of contraction was observed in the presence of tetrodotoxin (1 microM). Compared to atropine, the bladder spasmolytic agents propiverine, oxybutynin and tolterodine also reduced electrically evoked contractions in the three species, though higher concentrations were required. The differences in the reported effects of the spasmolytic agents commonly used for treating overactive bladder suggest that drug action is strongly dependent on the species. Thus, a comparison of drug effects is only feasible in the same animal model and the results cannot easily be transferred to humans.

Animals↗

PubMed2001

Tolterodine: a safe and effective treatment for older patients with overactive bladder.

OBJECTIVE: To investigate the clinical safety and efficacy of two dosages of tolterodine in older patients with symptoms attributable to overactive bladder. DESIGN: Randomized, double-blind, placebo-controlled, parallel-group, multinational, phase III study. SETTING: Incontinence, older care, urological, and urogynecological clinics in the United Kingdom, France, and the Republic of Ireland. PARTICIPANTS: One hundred and seventy-seven older patients (age > or =65 years) with symptoms of urinary urgency, increased frequency of micturition (> or =8 micturitions/24 hours), and/or urge incontinence (> or =1 episode/24 hours). INTERVENTION: Tolterodine 1 mg or 2 mg twice daily (bid), or placebo, for 4 weeks. MEASUREMENTS: Safety and tolerability were evaluated through spontaneously reported adverse events, electrocardiogram, and blood pressure measurements. Efficacy was assessed using micturition diary variables: mean change from baseline in frequency of micturition and number of incontinence episodes/24 hours. RESULTS: The mean age of the patient population was 75 years. Overall, > or =87% of patients completed the study. Neither dosage of tolterodine was associated with serious drug-related adverse events during the study. No cardiac arrythmogenic events were noted. Dry mouth (mild to moderate intensity) was the most common adverse event in both the placebo and tolterodine treatment groups. Three percent of patients in the tolterodine 2 mg bid group discontinued treatment because of dry mouth, compared with 2% of placebo-treated patients. Compared with placebo, statistically significant decreases in micturition frequency were apparent in both tolterodine treatment groups. Furthermore, patients treated with tolterodine 2 mg bid had statistically significant decreases in urge incontinence episodes/24 hours and increases in volume voided per micturition compared with placebo. CONCLUSION: Tolterodine (taken for 4 weeks) is safe and shows efficacy, particularly at a dosage of 2 mg bid, in the treatment of older patients with urinary symptoms attributable to overactive bladder.

Age Factors↗

PubMed2001

Transdermally-delivered oxybutynin (Oxytrol(R) for overactive bladder.

(1) The oxybutynin patch is a transdermal delivery system, which releases the drug oxybutynin through the skin for the management of overactive bladder. (2) Limited evidence suggests that transdermal delivery of oxybutynin over a short period of time may have efficacy comparable to oral oxybutynin. (3) Recent phase II and III clinical trials supported by the manufacturer suggest a potentially reduced incidence of dry mouth compared to oral oxybutynin. Itching, however, is present in 18% of patients, and the patients' withdrawal rate due to adverse events after 12 weeks is significant (10%). (4) More studies are required to determine the long-term efficacy and safety of the oxybutynin patch for overactive bladder. (5) A New Drug Application for transdermal oxybutynin (Oxytrol(R)) is currently under review at the U.S. Food and Drug Administration. As of October 2001, the oxybutynin patch has not been approved in Canada.

Administration, Cutaneous↗

PubMed2006

Pharmacologic management of overactive bladder: practical options for the primary care physician.

Overactive bladder (OAB) affects millions of people in the United States and is associated with poor health, impaired quality of life, social isolation, and depressive symptoms. Despite the high prevalence of this syndrome, studies show that it is not adequately addressed by the busy primary care physician, who may be preoccupied with management of other chronic diseases perceived as more serious such as heart disease, diabetes mellitus, and hypertension. Pharmacologic flexible-dosing studies with anticholinergic agents offer a relatively simple strategy for optimal management of OAB: physician-initiated, patient-managed dose adjustment. Recent flexible-dosing studies with extended-release oxybutynin, darifenacin, and solifenacin suggest that urge urinary and total incontinence episodes may be reduced significantly with a flexible-dosing strategy. Dose adjustment may improve the therapeutic outcome, facilitating a balance between efficacy and anticholinergic side effects such as dry mouth. Flexible-dosing studies indicate that dry mouth, the adverse effect most frequently seen with the use of anticholinergic agents, seldom leads to study withdrawal. Patient-initiated control of OAB symptoms may be achieved in 1 month by following established protocols.

Cholinergic Antagonists↗

PubMed2006

Patient-reported outcomes in overactive bladder: importance for determining clinical effectiveness of treatment.

Overactive bladder (OAB) is a condition defined by its symptoms--urinary urgency with or without urgency urinary incontinence and often with frequency and nocturia. As such, determining the efficacy of OAB treatments using objective measures, such as urodynamic testing, can be difficult. A better means of gauging treatment efficacy for symptom-based conditions is through the use of patient-reported outcomes (PROs). With PROs, clinicians can gain insight into how a treatment affects a patient's symptoms and whether improvement in symptoms has a positive effect from the patient's perspective. PROs are increasingly being included as end points in clinical trials, including those of antimuscarinic drugs for OAB. Consequently, clinicians should become familiar with the most commonly used instruments. We provide an overview of instruments used to assess symptoms, health-related quality of life, and treatment satisfaction in patients with OAB and discuss how PROs can be incorporated into clinical trial protocols.

Benzhydryl Compounds↗

PubMed2006

Physical and sexual abuse in patients with overactive bladder: is there an association?

The known sequelae of sexual abuse include acute and chronic injury. The purpose of this study was to evaluate the association of overactive bladder symptoms (OABs) with a history of physical or sexual abuse. Two hundred and forty-three women who attended the gynaecological out-patient clinic or the urogynaecological clinic were recruited for our study. Based on their clinical examination, they were assigned to three groups of patients with either OAB or with stress urinary incontinence (SUI) without concomitant urgency symptoms (SUI), or without history of incontinence (control group). Afterwards, they completed an anonymous questionnaire about bladder function and physical/sexual violence. Significantly more women (30.6%, 26/85) with OAB had previously been physically or sexually abused than women with SUI (17.8%, 18/101) and of the control group (17.5%, 10/57). Our study showed that significantly more women with OAB report physical and sexual abuse than subjects with stress incontinence or no urinary complaints. Women with stress incontinence had the same rate of self-reported physical/sexual abuse as continent controls.

Adult↗