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PubMed2005

Costs associated with the management of overactive bladder and related comorbidities.

STUDY OBJECTIVE: To evaluate the clinical and economic impact of overactive bladder (OAB) on the management of related comorbidities in a managed care population. DESIGN: Retrospective analysis of a claims database. SETTING: A large managed care organization in the United States. PATIENTS: A total of 11,556 patients with OAB who were aged 18 years or older and 11,556 control subjects without OAB who were matched on propensity score. MEASUREMENTS AND MAIN RESULTS: Patients and controls were identified from July 1-December 31, 2001, and followed for 360 days. The propensity score for matching controls was estimated based on patient demographics and diagnosis of important clinical conditions during a 180-day preindex period. Medical claims were examined for any diagnosis of the studied comorbidities. Submitted medical charges for claims with a primary or secondary diagnosis of the studied comorbidities were analyzed. Prevalence and medical charges for depression, skin infections, and vulvovaginitis were compared between patients with OAB and control subjects by using chi2 and t tests. Prevalence and medical charges for falls and fractures, urinary tract infections (UTIs), and any comorbidity were compared by using logistic regression and general linear modeling, to adjust for additional confounders not included in the matching process. Prevalence of all comorbid conditions was significantly higher (p<0.0001) for patients with OAB than for control subjects: falls and fractures, 25.3% versus 16.1%; depression, 10.5% versus 4.9%; UTIs, 28.0% versus 8.4%; skin infections, 3.9% versus 2.3%; vulvovaginitis, 4.7% versus 1.8%; any of these comorbidities, 52.1% versus 27.9%. Mean annual medical charges were significantly higher for patients than for controls for all comorbidities: falls and fractures, $934 versus $598 (p<0.0001); depression, $93 versus $23 (p<0.0001); UTIs, $603 versus $176 (p<0.0001); skin infections, $67 versus $10 (p=0.002); vulvovaginitis, $11 versus $3 (p<0.0001); any comorbidity, $1689 versus $829 (p<0.0001). CONCLUSION: This study quantifies the increased prevalence of and additional medical costs associated with related comorbidities in patients with OAB, emphasizing that the economic and clinical impact of OAB extends beyond the disease itself. Thus, management of patients with OAB should be of greater focus with both clinicians and health care payers.

Aged↗

PubMed2005

Update on the role of anticholinergic drug therapy in the management of overactive bladder.

OBJECTIVE: To review the published literature and describe the pathophysiology and management of overactive bladder (OAB), with emphasis on the comparative efficacy and adverse event profiles of anticholinergic agents approved for the management of OAB symptoms and evaluation of their place in therapy. DATA SOURCES: A MEDLINE search of English language literature that addresses the pathophysiology and management of OAB symptoms. The references in identified articles were evaluated for additional relevant articles. Drug Topics' Red Book was referenced for cost comparisons, and package inserts were used for specific drug and dosing information. STUDY SELECTION: Human studies that presented efficacy and safety data with respect to anticholinergic medications in the treatment of OAB were selected. DATA EXTRACTION: Studies were abstracted to identify key characteristics with respect to efficacy and safety in OAB, in particular anticholinergic side effects, with the greatest weight given to studies that compared two or more anticholinergic medications. DATA SYNTHESIS: Epidemiologic studies have shown that the unpredictable and bothersome symptoms associated with OAB occur in approximately 16% of the worldwide adult population. Conservative management of OAB should include a combination of pharmacologic and nonpharmacologic interventions that have been found to improve outcomes when used in appropriately selected patients. Although long recognized as the most effective pharmacotherapy for OAB, anticholinergic agents have been associated with poor tolerability attributable to anticholinergic adverse events. New medications, formulations, and drug delivery systems have been developed with the goal of achieving effective treatment with improved tolerability. CONCLUSIONS: Among these agents, extended-release and transdermal formulations have improved tolerability while retaining at least comparable efficacy. More research is needed regarding other routes of administration and new drug entities that specifically target the pathologic mechanisms involved in OAB.

Journal Article↗

PubMed2004

The autonomous bladder: a view of the origin of bladder overactivity and sensory urge.

Incontinence and the generation of excessive sensory urges are common problems that can seriously influence the quality of life of both men and women. The underlying causes have in some instances been associated with uncontrolled bladder activity. However, the mechanisms generating such activity are still poorly understood and pharmacological tools to control it remain relatively ineffective. There are no effective treatments for bladder overactivity possibly because the bladder mechanisms are not understand or targeted. The purpose of this short review is to raise questions and re-visit ideas from some older possibly forgotten and neglected publications, but which may shed new light on this problem.

Animals↗

PubMed2000

Intravesical oxyhemoglobin initiates bladder overactivity in conscious, normal rats.

PURPOSE: To investigate whether intravesical oxyhemoglobin, a nitric oxide scavenger, changes bladder activity in normal rats. MATERIALS AND METHODS: Oxyhemoglobin was given intravesically at different concentrations to conscious, female Sprague-Dawley rats undergoing continuous cystometry. RESULTS: Intravesical oxyhemoglobin increased bladder activity in a concentration-dependent way. At a concentration of 2.5 x 10-4 M (n = 8), micturition pressure (p <0. 01), basal pressure (p <0.01), and residual volume (p <0.05) increased, and bladder capacity (p <0.001) and micturition volume (p <0.001) decreased. The effect of oxyhemoglobin was reduced or abolished by L-arginine (200 mg./kg.-1), given intra-arterially near the bladder, and was enhanced by the guanylate cyclase inhibitor, ODQ (0.5 and 1 mg./kg.-1). The K+ channel opener, ZD6169 100 ng.ml. -1, given intravesically for 1 hour prior to instillation of oxyhemoglobin, reduced or completely prevented the bladder activity induced by oxyhemoglobin. CONCLUSIONS: Intravesical oxyhemoglobin induces bladder overactivity, probably by interfering with nitric oxide (NO) generated in the urothelium or suburothelially. NO may be involved in the regulation of the threshold for afferent firing in the bladder.

Administration, Intravesical↗

PubMed2004

Quantitative analysis of the levels of expression of muscarinic receptor subtype RNA in the detrusor muscle of patients with overactive bladder.

INTRODUCTION: Antimuscarinic drugs have frequently been used for the treatment for patients with an overactive bladder (OAB) and there have been many studies on the distribution of muscarinic receptor subtypes in the bladder. However, the distribution of muscarinic receptor subtypes in OAB patients has not been well investigated. In this study we investigated the distribution of muscarinic receptor subtypes with mRNA and protein expressions in patients with and without OAB, and investigated both the dome and trigone area. METHODS: Samples of bladder smooth muscle were obtained from 10 individuals, five patients with OAB and a non-OAB group consisting of five patients who received radical cystectomy. RESULTS: The M2 receptor was predominant, but there was no significant difference in the level of M2 expression between the groups in the dome area. M5 expression in the dome area was significantly higher in the OAB group than in the non-OAB group. In the trigone area, the level of M2 mRNA expression was the highest in the non-OAB group, and was significantly lower in the OAB group. The levels of M1 and M5 mRNA expression were also observed in samples obtained from the trigone area. CONCLUSION: The multiformity of the muscarinic receptor subtypes in human bladder smooth muscle was confirmed, and our results suggest that the efficacy of a given pharmacologic therapy differs from patient to patient.

Adult↗

PubMed2005

Comparison of dry mouth in women treated with extended-release formulations of oxybutynin or tolterodine for overactive bladder.

The incidence, severity and tolerability of dry mouth was compared in 790 women with overactive bladder who were treated with extended-release oxybutynin chloride 10 mg/day or extended-release tolterodine tartrate 4 mg/day for 12 weeks in a multicenter, double-blind, parallel-group study. Dry mouth was the most common adverse event associated with treatment, with an incidence rate of 28.1% in the oxybutynin group and 21.6% in the tolterodine group (P = 0.039). The majority of dry mouth events were mild in both treatment groups. Severe dry mouth occurred in 1.5% and 0.5% of patients in the oxybutynin and tolterodine groups, respectively (P = 0.173). Seven patients on extended-release oxybutynin and 4 patients on extended-release tolterodine discontinued treatment due to dry mouth (P = 0.380). The results of this analysis showed that dry mouth was common with both treatments, but most events were mild; there was no difference in the rate of severe dry mouth or in the rate of withdrawal due to dry mouth.

Adolescent↗

PubMed2006

Patient-reported outcomes in overactive bladder: the influence of perception of condition and expectation for treatment benefit.

Patient perceptions of overactive bladder (OAB) symptoms, expectations for treatment benefit, and overall treatment satisfaction share complex relations. Multiple studies have demonstrated associations between factors, such as age, sex, and ethnicity, and patient perceptions of OAB symptoms, especially urgency urinary incontinence. Perceptions of OAB are also shaped by symptom severity and impact on health-related quality of life, as well as by perceptions of family members, caregivers, and clinicians. The literature further suggests discrepancies in the reporting among patients, physicians, and family members/caregivers of the impact that urinary symptoms have on patients' emotional well-being, productivity, and daily life. Understanding the factors that affect patients' perceptions is important because these perceptions affect treatment expectations, which may predict treatment outcomes. Studies designed to evaluate the relations between expectations for OAB treatment and patient satisfaction have not been performed to date, but studies in other patient populations suggest that expectations of positive outcomes are associated with greater treatment satisfaction. We emphasize that patient satisfaction with treatment is directly related to fulfillment of positive expectations, and that patient expectations should be realistic and agreed on by patient and physician. We also discuss strategies that may be used by physicians managing patients with OAB to develop stronger patient-physician partnerships, including the effective communication required to make treatment decisions and set realistic expectations.

Age Factors↗

PubMed2002

Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q.

OBJECTIVE: Overactive bladder (OAB) is characterized by symptoms of urinary frequency and urgency, with and without incontinence, and has been shown to have significant impact on health-related quality of life (HRQL). Currently, no OAB-specific questionnaires exist to evaluate all symptoms of OAB; thus we sought to evaluate the psychometric properties of a newly developed OAB HRQL questionnaire. METHODS: The 33-item, self-administered OAB-q contains a symptom bother and HRQL scale. Both the OAB-q and SF-36 were completed by participants from two sources: (1) a community sample who screened positive for OAB in a random-digit dial telephone survey and participated in a clinical validation study (n = 254); and (2) a clinical study of patients' seeking treatment for OAB symptoms (baseline assessment) (n = 736). Item and exploratory factor analysis were performed to assess the subscale structure of the questionnaire. Psychometric evaluation was conducted to assess reliability and validity. RESULTS: Seventy-four percent of the sample were women with mean age of 58.5. Participants with continent and incontinent symptoms reported significantly greater symptom bother and HRQL impact than normal participants. Significant differences were present among all patient groups in all OAB-q subscales (p < 0.0001) except sleep where the impact of continent and incontinent OAB was similar, but significantly worse than normal participants (p < 0.0001). Internal consistency was high with the subscale Cronbach alpha-values ranging from 0.86 to 0.94. CONCLUSION: The OAB-q is a reliable and valid instrument that discriminates between normal and clinically diagnosed continent and incontinent OAB participants. The OAB-q demonstrates that both continent and incontinent OAB symptoms cause significant symptom bother and have a negative impact on HRQL.

Adaptation, Psychological↗

PubMed2003

Effectiveness of anticholinergic drugs compared with placebo in the treatment of overactive bladder: systematic review.

OBJECTIVE: To determine the effectiveness of anticholinergic drugs for the treatment of overactive bladder syndrome. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Published papers and abstracts. STUDY SELECTION: Randomised controlled trials with anticholinergic drug treatment in one arm and placebo in another. DATA EXTRACTION: Primary outcomes of interest were patient perceived cure or improvement in symptoms, differences in number of incontinent episodes and number of voids in 24 hours, and side effects. Secondary outcomes of interest were urodynamic measures of bladder function (volume at first contraction, maximum cystometric capacity, and residual volume) and adverse events. DATA SYNTHESIS: 32 trials were included, totalling 6800 participants. Most trials were described as double blind but were variable in other aspects of quality. At the end of treatment, cure or improvement (relative risk 1.41, 95% confidence interval 1.29 to 1.54), differences in incontinent episodes in 24 hours (estimated mean difference 0.6, 0.4 to 0.8), number of voids in 24 hours (0.6, 0.4 to 0.8), maximum cystometric capacity (54 ml, 43 ml to 66 ml), and volume at first contraction (52 ml, 37 ml to 67 ml), were significantly in favour of anticholinergics (P<0.0001 for all). Anticholinergics were associated with significantly higher residual volumes (4 ml, 1 ml to 7 ml; P=0.02) and an increased rate of dry mouth (relative risk 2.56, 2.24 to 2.92; P<0.0001). Sensitivity analysis, although affected by small numbers of studies, showed little likelihood of an effect of age, sex, diagnosis, or choice of drug. CONCLUSIONS: Although statistically significant, the differences between anticholinergic drugs and placebo were small, apart from the increased rate of dry mouth in patients receiving active treatment. For many of the outcomes studied, the observed difference between anticholinergics and placebo may be of questionable clinical significance. None of these studies provided data on long term outcome.

Cholinergic Antagonists↗

PubMed2005

Overactive bladder: evaluation and management in primary care.

Primary care physicians must initiate a discussion of overactive bladder and urinary incontinence with their patients who are at risk. A stepwise approach to evaluation and diagnosis and the use of systematic evaluation and treatment algorithms suitable to the primary care setting will improve identification and effective management of the incontinent patient.

Algorithms↗

PubMed2005

Changes of urinary nerve growth factor and prostaglandins in male patients with overactive bladder symptom.

AIM: Nerve growth factor (NGF) and prostaglandins (PG) in the urinary bladder can be affected by pathology of bladder, and this change can be noted in the urine. This study was performed to investigate the changes in urinary NGF and PG in male patient with overactive bladder (OAB) symptoms. METHODS: The study group included 75 male patients with OAB symptoms and 20 males without bladder symptoms as controls. Evaluation included history-taking, urinalysis, International Prostate Symptom Score (IPSS) and urodynamic study. The NGF, PGE2, PGF(2alpha) and PGI2 levels in voided urine were analyzed by enzyme linked immunosorbent assay and these results were compared in control and OAB patients. Also, the urinary levels of NGF and PG were correlated with IPSS score and urodynamic parameters in OAB patients. RESULTS: The urinary levels of NGF and PGE2 were signi fi cantly increased in patients with OAB compared with control (P < 0.05). The urodynamic study in OAB patients showed that more than half of the patients had detrusor overactivity and bladder outlet obstruction. The incidence of detrusor underactivity was noted in seven patients in the OAB group. The urinary level of PGE2 was decreased in patients with detrusor underactivity compared with patients without detrusor underactivity (P < 0.05), and negatively correlated with maximum bladder capacity in OAB patients (P < 0.05). CONCLUSIONS: NGF and PG may have important role in male patients with OAB, and the urinary level of PGE2 can change according to detrusor function. Therefore, these results may be used as urinary markers to evaluate the OAB symptoms.

Adult↗

PubMed2005

Prevalence of the overactive bladder syndrome by applying the International Continence Society definition.

PURPOSE: To determine the prevalence of the overactive bladder (OAB) syndrome in an urban population by using the International Continence Society (ICS) definition and to determine its impact on quality of life and sexual function. METHODS: Women and men participating in a health screening project in the area of Vienna completed the Bristol Lower Urinary Tract Symptoms (LUTS) questionnaire. To assess the prevalence of OAB the 2002 ICS definition was applied. In addition, all participants underwent a detailed health examination, including physical assessment, evaluation of life style factors, laboratory study and urinalysis. RESULTS: A total of 1199 men and 1219 women aged 20-91 years were analysed. The prevalence of OAB in men (48.5+/-13.1 years) was 10.2% (OABdry: 8.4%; OABwet: 1.8%) and 16.8% in women (49.5+/-13.5 years; OABdry:10.3%; OABwet: 6.5%). In women, the prevalence of OABdry remained fairly stable over 6 life decades, while OABwet increased substantially after the age of 40 years. In men OABwet and OABdry increased after the third life decade. In men with OAB, 48% did not report a negative impact on quality of life, 36% had minimal, 9.8% moderate and 2.5% severe impairment; the respective percentages for women were 53%, 33%, 7.3% and 6.3%. OABwet had a more profound impact on quality of life. A negative impact of OAB on sexuality was reported by 24% of men and 31% of women. CONCLUSION: The high prevalence of OAB in this population, its negative impact of quality of life and sexuality underline the importance of this syndrome.

Adult↗

PubMed2002

Influence of behavior modification on overactive bladder.

Behavioral interventions have been used for decades to treat urge incontinence and other symptoms of overactive bladder. Perhaps the earliest form of treatment was the bladder drill, an intensive intervention designed to increase the interval between voids to establish a normal frequency of urination and normalization of bladder function. Bladder training is a modification of bladder drill that is conducted more gradually on an outpatient basis and has resulted in significant reduction of incontinence in older, community-dwelling women. Multicomponent behavioral training is another form of behavioral treatment that includes pelvic floor muscle training and exercise. This intervention focuses less on voiding habits and more on altering the physiologic responses of the bladder and pelvic floor muscles. Using biofeedback or other teaching methods, patients learn strategies to inhibit bladder contraction using pelvic floor muscle contraction and other urge suppression strategies. Although behavioral and drug therapies are known to be highly effective for reducing urge incontinence, few patients are cured with either treatment alone. Thus, future research should explore ways to enhance the effectiveness of these conservative therapies. Although the mechanisms by which behavioral treatments work have not been established, there is some evidence that behavioral and drug interventions may operate by different mechanisms, suggesting that they may have additive effects and that combining them may result in better outcomes. Future research needs to examine the mechanisms by which these therapies reduce incontinence and whether combining behavioral and drug treatment will result in better outcomes than either therapy alone.

Behavior Therapy↗

PubMed2004

Vesical pacing in patients with overactive bladder: technique and results.

OBJECTIVES: A recent study has demonstrated that the electric activity of the overactive bladder (OAB) is 'dysrhythmic'. The cause was attributed to a disordered vesical pacemaker which discharges these waves. In a subsequent study, the dysrhythmic waves have been 'normalized' by vesical pacing and the optimal parameters which are required to achieve normalization have been defined. We investigated the hypothesis that vesical pacing of the OAB might improve not only the vesical electric activity but also the symptoms. METHODS: Vesical pacing was used in 9 patients (age 39.2 +/- 10.3; 5 women, 4 men) with OAB. Under anesthesia, the pacemaker was implanted in an inguinal subcutaneous pocket and connected to 2 pacing electrodes implanted into the vesical vault. The normalization of the waves was tested by 2 recording electrodes which were temporarily applied to the vesical wall and removed post-testing. The pacemaker was then programmed for home pacing to be activated at given times. RESULTS: Vesical pacing effected normalization of the dysrhythmic electric waves with disappearance of the OAB symptoms in 7 patients and failed in 2. Vesical pacing was abandoned in 3/7 patients after a few months following the spontaneous disappearance of the symptoms. CONCLUSIONS: Vesical pacing has normalized the dysrhythmic electric activity and suppressed the symptoms of the OAB in 77.7% of patients. The pacemaker was removed in 5 patients: 2 failures and 3 after spontaneous waves normalization. No complications were encountered. Vesical pacing is suggested as a treatment for OAB when commonly used therapeutic modalities have failed.

Adult↗

PubMed2004

Darifenacin: a novel M3 muscarinic selective receptor antagonist for the treatment of overactive bladder.

Darifenacin is a novel M3 muscarinic selective receptor antagonist for once-daily treatment of overactive bladder (OAB), a highly prevalent, chronic and debilitating disease defined by urinary urgency with or without urge incontinence, usually with increased frequency of micturition and nocturia. In vitro, darifenacin is a potent and specific muscarinic receptor antagonist with </= 59-fold higher selectivity for muscarinic M3 receptors relative to other muscarinic receptor subtypes. This profile may, therefore, confer clinical efficacy in the treatment of OAB, with a lower propensity for adverse effects and safety issues related to blockade of other muscarinic receptor subtypes. Indeed, consistent with its low relative affinity for M1 and M2 receptors, no effects on cognitive function and heart-rate variability, respectively, have been observed with darifenacin. Subsequent large-scale clinical trials have confirmed that darifenacin (at doses of 7.5 and 15 mg/day) results in central nervous system and cardiac adverse events comparable to placebo, and provides early and meaningful improvement across a range of OAB symptoms including incontinence episodes, urgency and urinary frequency. On the basis of such findings, darifenacin would appear to meet the current need for an effective OAB pharmacotherapy that is efficacious, well-tolerated and, more importantly, minimises the risk of safety-related adverse effects.

Benzofurans↗

PubMed2005

[Pharmacological evaluation of efficacy and safety of propiverine hydrochloride in patients of overactive bladder--relationship between urodynamic observation and propiverine pharmacokinetics--].

PURPOSE: The clinical benefit of propiverine hydrochloride against overactive bladder was evaluated, and the relationships between urinary voiding functions and the pharmacokinetics were investigated by means of clinical pharmacology with PK/PD approach. PATIENTS AND METHODS: Total 7 patients suffering urgency with urinary frequency and incontinence received propiverine hydrochloride in doses of 10 mg qd or 20 mg qd for 4 weeks, and then the doses were switched in cross-over manner to continue the treatment for further 4 weeks. The urodynamic measurements as well as pharmacokinetic samplings were done before the medication, 4 weeks and 8 weeks after the starting medication, to examine the dose-response and concentration-response relationships. RESULTS: The volume at first desire to void increased according to dose increased, and the volume at first involuntary contraction tended to increase according to both dose and drug concentration in plasma. However, no apparent dose-response relationships were observed for maximum urinary flow rate and the detrusor pressure at the maximum urinary flow rate. The PK/PD analysis using Emax model suggested that, approximately 75 ng/mL of the propiverine concentration in plasma allowed the increase in the volume at first involuntary contraction for 50%. The urinary residual volume increased in dose-dependent manner only in the patients with severe grade of lower urinary tract obstruction, but scarcely increased in the patients with moderate grade or below. CONCLUSION: Propiverine hydrochloride improved the urinary voiding functions with a tendency to depend on both dose and concentration in plasma. After the administration of propiverine hydrochloride, the concentration in plasma will immediately reach the level at which the drug can increase in the volume at first involuntary contraction for 50%, and then the concentration level will sustain the effect ranging from 10% to 50% increase in bladder volume. Furthermore, the lower urinary tract obstruction will be a predictor of increase in urinary residual volume.

Aged↗

PubMed2004

Antimuscarinics for the treatment of overactive bladder: current options and emerging therapies.

Antimuscarinic drugs have been the mainstay in the treatment of overactive bladder (OAB) for over two decades. An ideal antimuscarinic medicine is one that can normalize bladder function without interfering with parasympathetic regulation of other organs. Currently, extended-release formulations of tolterodine (tolterodine-ER) and oxybutynin (oxybutynin-ER and oxybutynin-TDS) serve as the cornerstone in the pharmacotherapy of OAB. Although these products represent a significant improvement over older agents, especially with respect to convenience of dosing schedule, their tolerability concerns and modest efficacy make them less than ideal therapies. Advances in our understanding of muscarinic receptor pharmacology have raised optimism in our ability to widen the therapeutic index and increase the efficacy of antimuscarinics by selectively targeting one or more of the five muscarinic subtypes. A structurally diverse group of molecules, having varying receptor-selectivity profiles (non-selective, M3 selective, M2 selective, M2 sparing and M5 sparing), are in development for OAB. Results of clinical trials with these drugs must be awaited before their therapeutic value can be accurately judged.

Animals↗

PubMed2005

Safety and tolerability of tolterodine for the treatment of overactive bladder in adults.

This article evaluates the safety and tolerability of tolterodine for the treatment of overactive bladder (OAB), which is defined as urinary urgency with or without urgency incontinence, usually with frequency and nocturia, but without infection or pathology. OAB affects tens of millions of people worldwide. Data are summarized from clinical trials and from postmarketing surveillance studies.

Adult↗