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PubMed2006

Assessment of treatment outcomes in patients with overactive bladder: importance of objective and subjective measures.

Overactive bladder (OAB) is a highly prevalent symptom syndrome that negatively affects health-related quality of life (HRQL). In clinical practice, the diagnosis and treatment of OAB are largely driven by a patient's reporting of symptoms, often in combination with objective assessment. Thus, OAB provides the opportunity to examine the relations between objective (eg, urodynamic studies, bladder diary variables) and subjective (eg, symptom bother, HRQL) outcomes. We compared objective and subjective results from 27 trials recently evaluated in a systematic review and meta-analysis of antimuscarinic agents used to treat OAB. Many studies demonstrated concurrent improvements in both types of outcomes. However, several reports showed that although pharmacotherapy may reduce micturition frequency or increase bladder capacity, treated patients may not perceive a significant benefit to HRQL. We conclude that objective assessments can help determine the underlying causes of OAB symptoms and assess the effects of treatment, but that these results are not always predictive of subjective outcomes, which are influenced by a patient's priorities and lifestyle, and thus highly individualized. A patient's perception of treatment success should be regarded as an important measure of efficacy because a patient considers the trade-offs between symptom improvement, adverse events, and effects on daily life when assessing overall treatment benefit. We recommend that subjective measures become standard considerations in the initial evaluation and treatment of patients with OAB.

Controlled Clinical Trials as Topic↗

PubMed2005

A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials.

PURPOSE: Overactive bladder (OAB) is a syndrome consisting of urinary urgency with or without urge incontinence, usually with increased urinary frequency and nocturia. In response to current limitations in OAB clinical research a new patient reported measure of urgency severity associated with OAB has been developed, namely the Indevus Urgency Severity Scale (IUSS). We report the measurement properties of the IUSS. MATERIALS AND METHODS: Validation study data were collected alongside a phase III clinical trial of 20 mg trospium chloride twice daily vs placebo in patients with OAB associated with urge incontinence. We evaluated IUSS item variability, known group, content, criterion and construct validity, test-retest reliability, responsiveness and respondent burden. RESULTS: A total of 658 patients were evaluated at baseline and 579 were reevaluated at week 12. IUSS demonstrated good item variability. Greater urgency severity was associated with increased symptom bother and worse health related quality of life, as measured by the OAB QOL questionnaire. IUSS had a significant positive association with essential clinical and quality of life outcomes, demonstrating content validity. IUSS was highly responsive to a decrease in the average number of patient toilet voids per 24 hours to 7 or fewer toilet voids and average urge incontinence episodes per 24 hours to zero. It discriminated between patients who had above and below the median number of toilet voids and urge incontinence episodes per 24 hours. IUSS also had good test-retest reliability and content validity, and it created minimal respondent burden. CONCLUSIONS: IUSS is a validated patient reported measure of urgency severity for collecting event specific information in the context of a clinical trial.

Adult↗

PubMed2005

Trospium chloride: an anticholinergic quaternary ammonium compound for the treatment of overactive bladder.

The International Continence Society has defined overactive bladder (OAB) as urinary urgency, with or without urge urinary incontinence, usually with urinary frequency and nocturia. Approximately 17% of men and women in the US report OAB symptoms, which can affect quality of life. Trospium chloride, which has recently been introduced in the US as Sanctura, has been prescribed for > 10 years in Europe as, for example, Spasmo-lyt, Regurin and Spasmex. Trospium chloride has been shown to be effective in relieving OAB symptoms, and has a favourable safety profile, showing < 1% difference for all adverse events compared with placebo, except for dry mouth, constipation and headache. Metabolic drug-drug interactions are unlikely, given that trospium chloride is not metabolised by cytochrome P450 isozymes. The fast-acting efficacy of trospium chloride, coupled with its good safety profile and tolerability, make it an important new option for treatment of OAB.

Benzilates↗

PubMed2000

Overactive bladder: special considerations in the geriatric population.

Overactive bladder (OAB) is a highly prevalent condition among older patients, and its presence is associated with the use of substantial healthcare resources and economic costs. Within the next 30 years, it is expected that the demand for services related to OAB will increase dramatically. Treatment of OAB is challenging and depends on several factors, including the age of the patient, cognitive functioning, and the degree of mobility. Pharmacotherapy, such as the use of tolterodine and oxybutynin, is a viable option for the treatment of OAB, and muscarinic antagonists are commonly used. The efficacy of an agent may differ in older patients compared with younger ones. In addition, certain side effects can be particularly troublesome in the geriatric population. A retrospective analysis of a large managed care database showed an age-related increase in the number of women seeking care for OAB. Caring for incontinent patients in the long-term care setting was shown to result in substantial additional costs, which were higher in those with more frequent incontinent episodes. Prompted voiding may be effective in reducing the number of incontinent episodes for those in institutionalized care; however, this practice is labor intensive and generally is only effective in 40% of cases. Moreover, assistance with prompted voiding must be maintained continuously. Future research should focus on defining the most cost-effective methods of treating OAB in the long-term care setting.

Adult↗

PubMedDate not supplied

Overactive bladder: treatment options for the aging woman.

Overactive bladder (OAB) is a common, chronic, and debilitating condition that is most often observed in the elderly population. It has a profound impact on the quality of life of patients, affecting many aspects of daily living, social interaction, and self-perception of health status. Possible neurological, muscular, and metabolic causes have been proposed, but in most cases the exact pathophysiology remains unclear. The management of OAB can be initiated conservatively with behavioral modification and antimuscarinics. For refractory cases, neuromodulation, denervation techniques, and bladder augmentation may be indicated. Not all patients are cured, but most may be improved with appropriate individualized therapy.

Activities of Daily Living↗

PubMed2005

[Overactive bladder: modulating the effects of antimuscarinic therapy].

Overactive bladder (OAB) is a prevalent pathologic condition affecting millions of young, adult and aging people in the world. Although it is a underestimated disease, it causes a significant negative socio-economic impact and determines a severe deterioration of quality of life (QoL) of sufferers. The epidemiologic data today available regarding OAB incidence, prevalence and burden, have prompted a great interest about it. The effect of this research resulted in the availability of new clinical tools useful to investigate and easier diagnose OAB, such as voiding diary and specific symptomatic questionnaires. The most used drugs in the OAB treatment are the antimuscarinics, whose use is still limited due to their some side effects, mostly dry mouth and constipation. For this reason the pharmacologic research is involved in the development of drugs with a better receptorial selectivity, organ specificity, new extended release formulations or new ways of administration. The new extended release formulation of tolterodine, one of the most used drugs in OAB treatment, present a better tolerability maintaining its efficacy, with a consequent better therapeutic efficacy. Furthermore, the recent proposed night-time administration of the drug resulted in a even more lowering of side-effects due to their occurrence during the nocturnal resting.

Humans↗

PubMed2002

The role of geriatricians and family practitioners in the treatment of overactive bladder and incontinence.

Although the prevalence of overactive bladder (OAB) and that of its symptoms (urinary urge incontinence, urgency, and frequency) increase with age, these conditions are not necessarily normal consequences of aging. Patients who present with urinary symptoms should be evaluated and treated, whether they are living on their own or in a residential, assisted-care, or long-term-care environment. Effective treatment for OAB and urinary incontinence (UI) is available and improves quality of life for the elderly. The primary care physician and geriatrician can accomplish a basic evaluation for UI using a systematic approach, as detailed in the following pages.

Journal Article↗

PubMed2007

Impact of self-perceived bothersomeness on health-related quality of life in women with overactive bladder symptoms.

INTRODUCTION: The objective of this study was to examine the impact of self-perceived bothersomeness of overactive bladder (OAB) symptoms on the health-related quality of life (QOL). PATIENTS AND METHODS: A total of 92 women with a mean age of 53.3 (range 23-79) years suffering from OAB were included in the study. The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and King's Health Questionnaire (KHQ) were used to assess the QOL. The patients were divided into two groups according to the bothersomeness degree of OAB: 'low' and 'moderate' to 'high'. RESULTS: The SF-36 and the KHQ scores of the patients were significantly different from those of the controls (p <0.05), except for three domains of the SF-36. No difference in the results of the frequency-volume charts was observed between the two patient groups. The scores of the SF-36 and the KHQ domains did not correlate with the data of the frequency-volume charts. Significant differences were found between the two patient groups for most domains of the SF-36 (p <0.05). Significant differences were also detected in most domains of the KHQ (p <0.05). CONCLUSIONS: Objective data are not a sensitive tool for measuring the QOL in women with OAB symptoms. Our findings suggest that patient-perceived bothersomeness significantly influences QOL and that strategies for assessing bothersomeness should be developed to evaluate the QOL in these patients.

Adaptation, Psychological↗

PubMed2006

Retrospective evaluation of outcomes in patients with overactive bladder receiving tolterodine versus oxybutynin.

PURPOSE: The frequency, relative risk, resource utilization, and costs related to comorbidities associated with overactive bladder (OAB) were studied. METHODS: A retrospective analysis of patients with OAB who initiated treatment with tolterodine extended release (ER), oxybutynin ER, or oxybutynin immediate release (IR) between January 2001 and December 2002 was conducted to evaluate the frequency, relative risk, resource utilization, and costs related to three specific comorbidities associated with OAB: urinary tract infections (UTIs), depression, and fracture. Two patient cohorts (tolterodine ER versus oxybutynin ER and tolterodine ER versus oxybutynin IR) were matched on a 1:1 basis according to their propensity to receive a prescription for tolterodine ER. RESULTS: The frequency and relative risk of UTIs were significantly lower in the tolterodine ER group than in the oxybutynin ER and oxybutynin IR groups. The relative risk of depression was also lower in the tolterodine ER group than the oxybutynin ER and oxybutynin IR groups; however, the differences were only significant in the tolterodine ER versus oxybutynin IR comparison. The utilization of UTI- and depression-related services and the number of antiinfective and antidepressant prescriptions were significantly lower in the tolterodine ER group than in the oxybutynin ER group. UTI- and depression-related costs were generally lower in the tolterodine ER group than in the oxybutynin ER or oxybutynin IR group. CONCLUSION: Treatment of OAB patients with tolterodine ER was associated with reduced frequency, relative risk, medical and pharmacy resource utilization, and incurred costs related to selected OAB-associated comorbidities compared with treatment with oxybutynin ER or oxybutynin IR.

Benzhydryl Compounds↗

PubMed2004

Efficacy of antimuscarinic therapy for overactive bladder with varying degrees of incontinence severity.

PURPOSE: We analyze the efficacy of tolterodine extended release (ER) for overactive bladder in patients with severe incontinence. MATERIALS AND METHODS: Patients with urinary frequency (8 micturitions or greater per 24 hours), urge incontinence (5 episodes or greater a week) and symptoms of overactive bladder for 6 months or greater were randomized to treatment with 4 mg tolterodine ER once daily or placebo for 12 weeks. Severe incontinence was defined as 21 episodes or greater per week at baseline. Changes in the number of incontinence episodes per week and micturition frequency after 12 weeks were compared between treatments. RESULTS: A total of 986 patients were eligible for this post-hoc analysis. After 12 weeks tolterodine ER produced a significant absolute median reduction in incontinence episodes per week compared to placebo (9.0 vs 5.0, p <0.0001). For patients with severe incontinence at baseline median absolute and percentage reductions in incontinence episodes per week were significantly greater with tolterodine ER than placebo (21.0 vs 9.5, p <0.0001; 67.6% vs 29.8%, p = 0.022). Micturition frequency decreased (p <0.02) and volume voided per micturition (p <0.0001) increased significantly more with tolterodine ER compared with placebo in these patients. For patients with nonsevere incontinence at baseline median reductions in incontinence episodes per week were also significantly greater with tolterodine ER than placebo (6.0 vs 4.0, p <0.0001; 71.4% vs 38.5%, p = 0.026). CONCLUSIONS: Patients with more severe incontinence at baseline achieved greater absolute reductions in incontinence with tolterodine compared to those with less severe symptoms. The degree of improvement, as measured by percent change, was comparable across the entire range of baseline incontinence severity strata. Benefits of antimuscarinic therapy may be greater in these patients than previously reported.

Female↗

PubMed2003

Assessment of an electronic daily diary in patients with overactive bladder.

OBJECTIVE: To assess the effectiveness of a portable electronic diary as a data collection device for overactive bladder symptoms, and to evaluate its level of patient acceptability compared with a conventional paper-based voiding diary. PATIENTS AND METHODS: Patients were identified through USA and UK hospital incontinence clinics. Patients were trained in the use of paper and electronic diaries before randomization, to complete either diary for 7 days. The diaries were then collected and, after a further training session, patients completed the other diary type for 7 days. RESULTS: In all, 35 patients were recruited into the trial; overall, patients using the paper diaries (35) and electronic diaries (33) recorded similar data for the median number of incontinent episodes per week (8.2 and 7.0, respectively) and for the median number of significant leaks per day (0.4 and 0.5, respectively). However, the number of daily micturitions was slightly lower for the electronic than for the paper diary (7.3 vs 8.5, respectively). The frequency of urgency recorded in the electronic diary was higher than that recorded in the paper diary (5.8 vs 4.7). As 94% of patients found the electronic diary easy to use, and the electronic diary reflects real-time data entries, the electronic diary data may provide a more accurate reflection of patient symptoms. CONCLUSION: We confirmed that the electronic diary is a novel method of collecting clinically relevant symptom data from patients with an overactive bladder. In addition, the ease-of-use ratings support the use of the electronic diary as a superior alternative to paper diaries, providing real-time data which can be rapidly analysed, and thus allowing a speedy review of data during ongoing clinical studies.

Adult↗

PubMed2000

A pharmacoeconomic evaluation of two new products for the treatment of overactive bladder.

The objective of this study is to evaluate the cost effectiveness of two new treatments for overactive bladder: once-daily controlled-release oxybutynin, and twice-daily tolterodine, with a comparison with oxybutynin immediate release. Also estimated are the potential cost savings to a health plan budget resulting from increased utilization of the most cost-effective treatment. The design is a decision-tree model based on clinical trial data and expert panel estimates with a six-month time horizon conducted from a payer perspective. The primary outcome measure used in the analysis was treatment success, with success defined as zero incontinence episodes per week. A secondary outcome measure was the expected number of continent days. As first-line therapy, controlled-release oxybutynin is the most cost-effective treatment as measured by expected cost per success and expected cost per continent days. Controlled-release, once-daily oxybutynin yielded the highest expected success rate and the highest number of expected continent days. The expected cost of treatment with controlled-release oxybutynin was lower than tolterodine and equivalent to immediate-release oxybutynin. Increased utilization of controlled-release oxybutynin results in an estimated saving of $0.007 to $0.026 per member per month for a hypothetical HMO. The model was robust, incorporating all assumptions based on univariate and multivariate sensitivity analysis. Initiating treatment with controlled-release oxybutynin is the most cost-effective approach to treatment for overactive bladder.

Benzhydryl Compounds↗

PubMed2006

What is the optimum dose of type A botulinum toxin for treating neurogenic bladder overactivity?

OBJECTIVE: To assess the effects of two doses of botulinum toxin A (Dysport, Ipsen-Biotech, France; 500 and 1000 Speywood units, SU) injected into the bladder for treating incontinence due to a neurogenic overactive bladder. PATIENTS AND METHODS: In an open-label, prospective study between October 2002 and May 2004, in two centres, we analysed the effects of successive doses of 500 and 1000 SU of Dysport, endoscopically injected into the detrusor muscle. At each step, patients (26 women and 19 men) were re-evaluated at 1 month (clinical evaluation and pressure-flow study). If there was a 'good' clinical response (complete absence of urinary leakage) the patient was observed until incontinence recurred; otherwise a further injection was administered at a higher dose. RESULTS: The mean (sd, range) follow-up was 22 (0.75, 5-31) months; 11 of the 45 patients (24%) did not respond primarily at 1 month for both doses. The analysis of the two curves of survival with no re-injection of Dysport showed a statistically longer action at 1000 SU (P = 0.016). However, in this group there was one patient with general muscle weakness and asthenia, which could have been related to the injection. CONCLUSIONS: The optimum dose of Dysport for incontinence secondary to a neurogenic overactive bladder is not yet defined; 1000 SU probably has a more prolonged effect than 500 SU but exposes the patient to major complications. Further studies evaluating the clinical effect of 750 SU of Dysport are necessary.

Botulinum Toxins, Type A↗

PubMed1998

Cost-effectiveness of new treatments for overactive bladder: the example of tolterodine, a new muscarinic agent: a Markov model.

Economic analyses of interventions for chronic diseases require evaluations over a long timeframe to illustrate the benefits and costs of treatments. Clinical trials are generally short and carried out in strictly controlled conditions. They are therefore of limited value for economic evaluation aimed at facilitating decisions about resource allocation. The objective of this study was to develop a simulation model that allows integration of data from different sources to calculate the incremental cost-effectiveness and cost-utility of new treatments for overactive bladder. The model compares tolterodine, a new treatment that aims at alleviating symptoms and improving patients' quality of life, to no treatment. Simulations for Sweden are presented as an example. The Markov model combines clinical, observational, and economic data. Markov states are defined based on severity of symptoms of overactive bladder (frequency of voids and leaks). Specific costs for drug treatment and use of sanitary protections as well as utilities are assigned for each state. The effectiveness of tolterodine is based on controlled clinical trials and open long-term extensions of these trials. Outcome is measured as quality-adjusted life years (QALYs) and as the number of months spent in a state with no or very limited symptoms. During the course of 1 year, patients treated with tolterodine spend more time in states with no or limited symptoms compared to those receiving no treatment. Tolterodine-treated patients having a better quality of life during the year. The mean utility of the treated cohort is 0.70, compared to 0.67 in the no-treatment cohort, which is equivalent to the entire cohort moving by one level to a state with less severe symptoms. Mean total costs per patient in the tolterodine arm are SEK8,595 (US $1,131; 1 US$ = 7.6 SEK) compared to SEK3,286 (US$432) in the no-treatment arm. The extra cost due to tolterodine is SEK380 (US$50) per month, which falls within the range of monthly amounts that patients were willing to pay out of pocket for a 25 or 50% improvement of their symptoms in a previous study. The cost for pads is reduced by 23%. The marginal cost per QALY gained with tolterodine is estimated at SEK213,000 (US$28,000). Based on this simulation model, it appears that treatment of overactive bladder with a well-tolerated pharmacological treatment such as tolterodine is cost-effective.

Benzhydryl Compounds↗

PubMed2000

Role of the forebrain in bladder overactivity following cerebral infarction in the rat.

This study was undertaken to investigate the contribution of the forebrain to bladder overactivity induced by cerebral infarction (CI). CI was induced by left middle cerebral artery (MCA) occlusion in female SD rat. Two and a half hours after CI or a sham operation (SO) decerebration was performed in some animals to eliminate forebrain influences on voiding function. Then bladder activity was monitored during continuous infusion cystometrograms in awake rats for 2.5 h. The effects of cumulative intravenous doses of MK-801 (0.1-1.4 mg/kg), an NMDA (N-methyl-D-aspartate) glutamatergic receptor antagonist, or sulpiride (0.1-41.1 mg/kg), D(2) selective dopaminergic receptor antagonists were studied over a 1.5-h period beginning 5 h after MCA occlusion. Bladder capacity was reduced by 57.5% after CI. In CI rats decerebration increased bladder capacity by 62.5% of predecerebration capacity. In SO rats bladder capacity was reduced by 25% after decerebration. MK-801 (0.4 and 1.4 mg/kg) increased bladder capacity in CI and CI-decerebrate rats, but did not change bladder capacity in SO-decerebrate rats. MK-801 decreased (60.7%) bladder capacity in SO-nondecerebrate rats. Sulpiride (11.1 and 41.1 mg/kg) significantly increased bladder capacity in CI, CI-decerebrate, and SO-decerebrate rats, but had no effect in SO-nondecerebrate rats. These results indicate that CI-induced decrease in bladder capacity is mediated by two mechanisms: (1) upregulation of an excitatory pathway from the forebrain, an effect blocked by decerebration and (2) downregulation of a tonic inhibitory pathway from the forebrain. The latter effect which can be induced by decerebration as well as CI unmasks a D(2) dopaminergic excitatory mechanism. An NMDA excitatory mechanism also contributes to the bladder overactivity after CI, but not after decerebration.

Animals↗

PubMed2006

Impact of stress urinary incontinence and overactive bladder on micturition patterns and health-related quality of life.

We examined the impact of stress urinary incontinence (SUI) and overactive bladder (OAB) on micturition habits and health-related quality of life (QOL). A total of 250 Korean women were included in the study. The Medical Outcomes Study Short Form (SF-36) and the King's Health Questionnaire (KHQ) were used to assess QOL in the patient (SUI, n=158 and OAB, n=92) and control (n=70) groups. A control group was recruited at the Health Promotion Center of our hospital. Each of the dimension scores in the SF-36 represents better health, while that of the KHQ does worse health perception. On the frequency-volume charts, patients with OAB had more nighttime voids than those with SUI (P=0.001). Of the eight domains in the SF-36 questionnaire, four domains were significantly different between the control and OAB groups. Patients with SUI had a significantly lower score on one domain than the controls. Between the SUI and OAB groups, only one domain showed a significant difference. Regarding the KHQ, all domain scores in control subjects were significantly lower than those in the SUI and OAB groups. Between the SUI and OAB groups, the OAB group had higher scores on 'general health perception' and 'sleep/energy disturbances', while the scores of 'physical limitations' and 'severity measures' were higher in the SUI group. Women with OAB have a higher number of nocturic episodes than those with SUI, but the QOL is not less affected by SUI than by OAB. Furthermore, simultaneous disease-specific QOL instruments should be used in the evaluation of urinary incontinence because the generic QOL instrument is not a sensitive tool for measuring QOL in this population.

Female↗

PubMed2007

Comparative evaluation of central muscarinic receptor binding activity by oxybutynin, tolterodine and darifenacin used to treat overactive bladder.

PURPOSE: We characterized muscarinic receptor binding in the mouse cerebral cortex after oral administration of anticholinergic agents used to treat overactive bladder. MATERIALS AND METHODS: Muscarinic receptors in the mouse cerebral cortex and bladder after oral administration of anticholinergic agents were measured using [(3)H]N-methylscopolamine. RESULTS: In vitro binding affinities of tolterodine and its metabolite 5-hydroxymethyl metabolite in the mouse cerebral cortex and bladder were considerably greater than those of oxybutynin and darifenacin. Also, muscarinic receptor binding affinity of oxybutynin and its metabolite N-desethyl-oxybutynin in the cerebral cortex compared with that in the bladder was 2 to 3 times higher, whereas that of tolterodine and 5-hydroxymethyl metabolite was approximately 2 times lower. Oral administration of oxybutynin (76.1 micromol/kg), tolterodine (6.31 micromol/kg) and darifenacin (59.1 micromol/kg) showed binding activity that was approximately equal to that of bladder muscarinic receptors. Oral administration of oxybutynin (76.1 micromol/kg) showed significant binding of cerebral cortical muscarinic receptors in mice, as indicated by about a 2-fold increase in K(d) values for specific [(3)H]N-methylscopolamine binding 0.5 and 2 hours later. On the other hand, tolterodine and darifenacin given at oral doses that would exert a similar extent of bladder receptor binding activity as oxybutynin showed only a low level of binding activity of central muscarinic receptors in mice. CONCLUSIONS: Significant binding of brain muscarinic receptors in mice was observed by the oral administration of oxybutynin but not tolterodine and darifenacin.

Animals↗

PubMed2003

Voiding urgency and detrusor contractility in women with overactive bladders.

AIMS: To check whether the contractility of overactive bladders would be affected by voiding urgency. METHODS: We urodynamically studied 100 women: 20 normal controls (group 1), 60 patients with idiopathic detrusor overactivity (DO), and 20 with neurogenic DO from intracerebral lesions. The idiopathic DO groups 2A (n = 20), 2B (n = 20), and 3 (n = 20) had moderate, severe, and no voiding urgency, respectively. The neurogenic DO group 4 had severe urgency. The delay time of urgent void at cystometry (2 minutes or more or, respectively, less than 2 minutes) defined moderate or severe urgency. Detrusor contractility was defined by the maximum bladder external voiding power (WF(max)). RESULTS: WF(max) was higher in the idiopathic DO patients than in the controls, had the highest values in group 2B, and did not differ significantly between groups 1-4 and 2A-3. CONCLUSIONS: We inferred from our data that idiopathic DO suggests a facilitation of voiding contractions and that such facilitation might be centrally amplified by severe urgency. This amplifying effect would probably be impaired in cases of neurogenic DO from intracerebral lesions.

Adult↗