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PubMed2005

Long-term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome.

OBJECTIVE: To examine safety and tolerability findings as primary endpoints, and efficacy outcomes as secondary endpoints, of solifenacin treatment over a period of up to 1 year. Long-term efficacy in the treatment of overactive bladder (OAB) syndrome depends in part on the patient's persistence with pharmacologic therapy. Agents with a favourable therapeutic index supporting high levels of patient satisfaction and persistence are needed. METHODS: The present study was a 40-week open-label extension of two 12-week, placebo-controlled, double-blind studies of solifenacin treatment in patients with OAB. Patients who completed the 12-week studies were offered participation in the open-label extension study. All patients who entered the open-label extension study initially received solifenacin 5 mg daily for 4 weeks, after which a flexible dosing regimen allowed patients to individualise their treatment (5 mg or 10 mg) at each of the 3 study visits. Safety and tolerability assessments (the primary variable) included adverse event reporting. Efficacy data were collected from micturition diaries completed at weeks 16, 28, 40, and 52. RESULTS: Ninety-one percent (1637/1802) of patients who completed the two 12-week randomised studies chose to participate in the long-term open-label extension study. A total of 81% of patients completed 40 weeks of open-label treatment. Solifenacin treatment was safe and well tolerated, and rates of anticholinergic side effects were relatively low. Only 4.7% of patients discontinued treatment owing to adverse events. Improvements in major symptoms of OAB were noted for all patients for up to 52 weeks of treatment. In patients randomised to solifenacin in the double-blind studies, there were small incremental improvements in all efficacy parameters (reductions in episodes per 24 hours of urgency, reductions in frequency and urge incontinence, and increases in volume voided per micturition) over the course of the extension study. Efficacy was confirmed when outcomes were assessed as a function of total solifenacin exposure. Patient satisfaction with solifenacin tolerability (85%) and efficacy (74%) were high. These results indicate that long-term treatment with solifenacin was well tolerated and associated with improvements in efficacy parameters based on patient diary data recorded over the 12-month treatment period. Moreover, the high level of patient satisfaction reported appeared to correlate well with the quantified improvements in key symptoms demonstrated in this study. CONCLUSIONS: Long-term therapy with solifenacin resulted in a favourable tolerability profile, and was associated with improvements in efficacy parameters based on diary data recorded over a 12-month period. This balance of tolerability and efficacy with solifenacin was associated with excellent persistence with therapy. These results suggest that solifenacin may be useful for the long-term treatment of the chronic symptoms associated with OAB.

Constipation↗

PubMed2000

Findings of a three-year retrospective study to investigate prevalence and incidence of urinary incontinence and overactive bladder in a typical managed care setting.

This study was conducted in a large, integrated HMO to determine the prevalence and incidence of urinary incontinence, identify a demographic profile of patients having the UI subgroup condition of overactive bladder, and collect data to create an economic cost of illness description regarding current diagnosis and treatment practices. Using ICD-9 and CPT codes and prescription drug claims data as markers for the disease, subjects were selected for inclusion in the study. Resource use cost data was collected from this cohort over a three-year period and analyzed for total and mean monthly costs.

Adolescent↗

PubMed2005

Comparison of darifenacin and oxybutynin in patients with overactive bladder: assessment of ambulatory urodynamics and impact on salivary flow.

OBJECTIVES: To evaluate the effects of darifenacin, an M3 selective receptor antagonist, compared with oxybutynin, on ambulatory urodynamics, salivary flow, heart rate and visual nearpoint in patients with overactive bladder (OAB). METHODS: A double-blind, randomized, crossover study (n=65) with three treatment cohorts: darifenacin immediate release (IR) 2.5 mg three times a day (t.i.d.) or oxybutynin 2.5 mg t.i.d.; darifenacin controlled release (CR) 15 mg once daily (q.d.) or oxybutynin 5 mg t.i.d.; darifenacin CR 30 mg q.d. or oxybutynin 5 mg t.i.d. Within cohorts, patients received 7 days' treatment with each agent separated by 14 days' washout. RESULTS: All active treatments improved urodynamic parameters. Both darifenacin CR doses had significantly less effect on salivary flow than oxybutynin. Effects on urodynamic parameters, heart rate and visual nearpoint were comparable. CONCLUSION: Ambulatory urodynamics appears to be an innovative and potentially useful investigative tool in the evaluation of the efficacy of new therapeutic agents. Darifenacin CR is an efficacious therapy for OAB with comparable effects on urodynamic parameters but producing significantly less dry mouth than oxybutynin.

Adolescent↗

PubMed2005

A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder.

OBJECTIVE: To evaluate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), from an analysis of pooled data from three phase III, multicentre, double-blind clinical trials in patients with overactive bladder (OAB). PATIENTS AND METHODS: After a 4-week washout/run-in period, 1059 adults (85% women) with symptoms of OAB (frequency and urgency with urge incontinence) for > or = 6 months were randomized to once-daily oral treatment with darifenacin (7.5 mg, 337; or 15 mg, 334) or matching placebo (388) for 12 weeks. Efficacy was evaluated using electronic patient diaries that recorded incontinence episodes (including those resulting in a change of clothing or pads), frequency and severity of urgency, voiding frequency, and bladder capacity (volume voided). Safety was evaluated by analysis of adverse events (AEs), withdrawal rates and laboratory tests. RESULTS: Relative to baseline, 12 weeks of treatment with darifenacin resulted in a significant reduction in the median (% change, interquartile range) number of incontinence episodes per week; 7.5 mg (-8.8, -68.4%, -15.1 to -4.4); 15 mg; (-10.6, -76.8%, -17.3 to -5.8: both P < 0.01 vs placebo). There was a significant dose-response trend in each study for which darifenacin 7.5 and 15 mg were evaluated (P < 0.01). There were also significant decreases in the frequency and severity of urgency, voiding frequency, and number of significant leaks (incontinence episodes resulting in a change of clothing or pads; both P < or = 0.001 vs placebo), together with an increase in bladder capacity (both P < 0.01 vs placebo). Darifenacin was well tolerated; the most common AEs were dry mouth and constipation, although together these resulted in few discontinuations (darifenacin 7.5 mg 0.6% of patients; 15 mg 2.1%; placebo 0.3%). The incidence of peripheral/central nervous system and cardiovascular AEs were comparable with those on placebo. CONCLUSIONS: Darifenacin (7.5 and 15 mg once daily) is effective in the treatment of patients with OAB. As predicted by its M3 selectivity and associated M1/M2-sparing profile, darifenacin was well tolerated with no central nervous system or cardiovascular safety concerns.

Adult↗

PubMed2005

QT and QTc interval with standard and supratherapeutic doses of darifenacin, a muscarinic M3 selective receptor antagonist for the treatment of overactive bladder.

Prolongation of QT interval on an electrocardiogram is a valuable predictor of a drug's ability to cause potentially fatal ventricular tachyarrhythmia (torsades de pointes). Darifenacin is a muscarinic M3 selective receptor antagonist developed for the treatment of overactive bladder, a debilitating condition that is particularly prevalent in the older population. This 7-day, randomized, parallel-group study (n=188) measured QT/QTc interval in healthy volunteers receiving once-daily darifenacin at steady-state therapeutic (15 mg) and supratherapeutic (75 mg) doses, alongside controls receiving placebo or moxifloxacin (positive control, 400 mg) once daily. There was no significant increase in QTcF interval with darifenacin treatment compared with placebo. Mean changes from baseline at pharmacokinetic Tmax versus placebo were -0.4 and -2.2 milliseconds in the darifenacin 15 mg and 75 mg groups, respectively, compared with +11.6 milliseconds in the moxifloxacin group (P<.01). This study demonstrates that darifenacin does not prolong QT/QTc interval.

Adolescent↗

PubMed2005

Economic impact of extended-release tolterodine versus immediate- and extended-release oxybutynin among commercially insured persons with overactive bladder.

OBJECTIVE: To examine levels of persistence and compliance as well as the economic impact of extended-release tolterodine (tolterodine ER) versus immediate- and extended-release oxybutynin (oxybutynin IR or oxybutynin ER) among commercially-insured patients with overactive bladder (OAB). METHODS: Patients with OAB who initiated tolterodine ER, oxybutynin IR, or oxybutynin ER between January 2001 and December 2002 were identified from the PharMetrics Patient-Centric database; the first medication used in this timeframe was used for treatment group assignment (ie, patients were only in 1 group). Exploratory assessment of persistency and compliance was conducted among all treated patients: subjects were matched 1:1 based on the estimated propensity score for tolterodine ER in remaining analyses. Measures included patient characteristics as well as levels of medication, outpatient and inpatient resource utilization, and costs. Primary comparisons were made descriptively; costs were evaluated using generalized linear models with a gamma distribution and log-link function. RESULTS: Compliance did not differ between tolterodine ER (77.4%) and oxybutynin ER (74.3%), but was lower for oxybutynin IR (60.9%). Mean (+/- standard deviation) duration of therapy was higher for tolterodine ER (139 +/- 132 days) versus oxybutynin ER (115 +/- 122) and oxybutynin IR (60 +/- 85). Totals of 7257 and 5936 matched pairs were available for tolterodine ER versus oxybutynin ER and oxybutynin IR comparisons, respectively. The mean age was 54 years in all groups; the majority was women. Utilization of outpatient and inpatient medical services was consistently lower among tolterodine ER patients in both comparisons. Total costs were slightly lower for tolterodine ER versus oxybutynin ER (dollar 8303 +/- dollar 18 802 vs dollar 8862 +/- dollar 18 684) and oxybutynin IR (dollar 9975 +/- dollar 24860 vs dollar 10521 +/- dollar 22 602); differences were significant after multivariate adjustment. CONCLUSIONS: Use of tolterodine ER results in comparable compliance to oxybutynin ER and longer duration of use relative to either form of oxybutynin. In addition, tolterodine ER may be cost-effective relative to oxybutynin IR or oxybutynin ER among commercially-insured persons with OAB.

Aged↗

PubMed2001

Lidocaine cystometry in the diagnosis of bladder overactivity.

The effect of intravesical lidocaine was studied in a group of patients with symptoms of urinary urgency with or without incontinence. Provocative water cystometry failed to demonstrate signs of unstable detrusor but all patients presented a continuous, steep rise of detrusor pressure at the end phase of filling. Repeat cystometry was performed after the bladder had been treated with 3 g lidocaine intravesically for 20 minutes. In the majority of patients, no change in configuration of the cystometrogram was noted. In a group of patients, a decrease of detrusor pressure occurred and there was also an influence on phasic bladder contractions. In three patients, phasic detrusor contractions developed after lidocaine. Thus, intravesical lidocaine seems to be a useful tool to increase the precision of the urodynamic diagnosis in bladder overactivity.

Adult↗

PubMed2004

Preview of new drugs for overactive bladder and incontinence: darifenacin, solifenacin, trospium, and duloxetine.

This year, the US Food and Drug Administration will approve four new drugs indicated for the treatment of lower urinary tract dysfunction. Darifenacin, solifenacin, and trospium are antimuscarinic agents aimed at relieving the symptoms of overactive bladder and urge incontinence in men and women. Duloxetine will be the first drug approved for the treatment of female stress urinary incontinence. This article presents current data on the efficacy and tolerability of these new agents and invites the reader to decide whether they offer any potential advantages over existing therapies.

Benzilates↗

PubMed2006

Long-term treatment with darifenacin for overactive bladder: results of a 2-year, open-label extension study.

OBJECTIVE: To examine, in a 2-year, non-comparative, open-label extension study, the safety, tolerability and efficacy of darifenacin controlled-release (CR) 7.5/15 mg once daily in patients with overactive bladder (OAB) who completed two 12-week randomized, double-blind, placebo-controlled 'feeder' studies. PATIENTS AND METHODS: Patients entering the extension received darifenacin 7.5 mg once daily for 2 weeks, after which a voluntary increase in dose to 15 mg was permitted. Thereafter, patients could adjust the dose (either 7.5 or 15 mg). Safety and tolerability were assessed from adverse events (AEs) and discontinuations. Efficacy was determined using various endpoints. RESULTS: In all, 716 patients entered the extension (mean age 57.3 years; 85.1% women) and 475 (66.3%) completed it (1089.9 patient-years of exposure). Darifenacin was well tolerated with no significant safety concerns. The most commonly reported AEs were dry mouth and constipation (all-causality rates 23.3% and 20.9%, respectively), leading to discontinuation in 1.3% and 2.4% of patients, respectively. Constipation infrequently required intervention, and analysis of bowel-habit questionnaires revealed that the reporting of constipation was related to minor changes in bowel habit rather than true constipation. The efficacy of darifenacin was maintained, including significant improvements in the number of incontinence episodes/week (median change -84.4% at 2 years, P < 0.001 vs feeder-study baseline). After 2 years, > 40% of patients achieved a > or = 90% reduction in incontinence episodes/week. CONCLUSION: In the first published 2-year, open-label study of a CR antimuscarinic agent, darifenacin 7.5/15 mg once daily had a favourable safety, tolerability and efficacy profile during the long-term treatment of OAB. As such, darifenacin represents a valuable therapeutic option for OAB.

Adult↗

PubMed2005

New pharmacological treatments for urinary incontinence and overactive bladder.

Lower urinary tract dysfunction encompasses a number of different pathologies, and affects the lives of millions of patients worldwide. Although several pharmaceutical companies have been involved in urological drug discovery over the last several years, therapeutic options remain limited. The mainstay of treatment for overactive bladder and urinary incontinence for several years has been antimuscarinic agents. While additional antimuscarinic compounds are currently undergoing clinical development, next generation compounds aimed at novel targets and mechanisms of action are in clinical and preclinical development. This review highlights new compounds and approaches under clinical investigation by various pharmaceutical companies. These novel therapeutic strategies offer the promise of expanded treatment options for patients suffering from these disorders.

Animals↗

PubMed2002

Overactive bladder in men: special considerations for evaluation and management.

Lower urinary tract symptoms (LUTS) in men may arise from a variety of underlying causes, including benign prostatic hyperplasia. LUTS may have a significant component of storage symptoms (urgency, frequency, urge incontinence) at presentation; however, the absence of overactive bladder (OAB) symptoms does not necessarily imply pure outlet obstruction nor does their presence indicate the lack thereof. Symptomatic correlates to urodynamic findings are high when considering isolated OAB symptoms. However, mixed presentations or more overtly obstructive scenarios have less correlation with baseline symptom appraisal instruments. The ideal approach for diagnosis and management is predicated on a graded approach, with more invasive evaluation withheld for those men in whom presumptive therapy fails or who present with associated complex symptoms and in whom a higher level of intervention is being considered. The increasing incidence of LUTS with age implies a partial detrusor contribution, which must be considered in the overall management schema.

Adult↗

PubMed2001

Oxybutynin and the overactive bladder.

Oxybutynin is a tertiary amine, which undergoes an extensive first-pass metabolism. It has an active metabolite, N-desethyl oxybutynin, and the effect of oral oxybutynin is to a large extent exerted by this metabolite. Oxybutynin has both an antimuscarinic and a direct muscle relaxant effect, and, in addition, local anesthetic actions. Most probably, oral oxybutynin exerts its effects on the overactive bladder (OAB) by an antimuscarinic action. Several studies have shown that oral oxybutynin is effective in controlling OAB. Admininistred intravesically, it can increase bladder capacity and produce clinical improvement both in patients with hypereflexia and in other types of OAB with few side effects. Adverse effects related to the antimuscarinic activity occur frequently and can necessitate treatment discontinuation in up to 25% of patients, depending on the dosage. A controlled-release preparation has recently been introduced. Oxybutynin has a well-documented efficacy in the treatment of detrusor overactivity, and is a drug of first choice in patients with this disorder.

Humans↗

PubMed2006

[Overactive bladder: prospects and limitations of botulinum toxin].

Botulinum toxin is the most potent poison known to man. It is produced by Clostridium botulinum and consists of a heavy chain which is responsible for the internalization of the toxin into the cytosol and a light chain that has the ability to cleave proteins within the nerve terminal. As those proteins are essential for normal vesicular transport and fusion of acetylcholine, botulinum toxins are able to prevent its release at the presynaptic membrane, resulting in a chemodenervation of the detrusor muscle after intravesical injection of the toxin and an impressive reduction of symptoms of overactive bladder. Clinical studies show success rates between 60 and 96% for neurogenic and non-neurogenic detrusor overactivity. Thus, application of botulinum toxin to the lower urinary tract appears to be an efficient, safe and minimally invasive procedure.

Administration, Intravesical↗

PubMed2005

Solifenacin in overactive bladder syndrome.

Solifenacin is a bladder-selective, muscarinic (M(1) and M(3)) receptor antagonist. In animal studies, the selectivity of solifenacin for the bladder over the salivary glands was greater than that of tolterodine, oxybutynin, darifenacin or atropine. In large, 12-week, randomised, double-blind, multicentre clinical trials, solifenacin 5 and 10mg once daily improved symptoms of overactive bladder syndrome (OAB) [urinary urgency, frequency, incontinence and nocturia] and increased functional bladder capacity to a significantly greater extent than placebo. Solifenacin 5 or 10mg once daily was noninferior to tolterodine extended release (ER) 4mg daily for improving urinary frequency and had significantly greater efficacy than tolterodine ER for improving other symptoms of OAB (episodes of urgency, incontinence and urge incontinence) and increasing functional bladder capacity. At least half of all patients receiving solifenacin who were incontinent at baseline were continent by study end in the three comparative studies reporting this parameter. Health-related quality of life was significantly improved with once-daily solifenacin 5 or 10mg versus placebo, as assessed in two 12-week double-blind studies; the improvement was maintained during a 40-week extension study. Solifenacin was generally well tolerated; the most frequently reported adverse events were dry mouth, constipation and blurred vision.

Humans↗

PubMedDate not supplied

The effect of overactive bladder syndrome on the sexual quality of life in Korean young and middle aged women.

Some reports showed that urinary incontinence (UI) or female lower urinary tract symptoms (LUTS) affect life quality and sexual activity. In clinical practice, it is commonly found that not only the symptoms of UI but also overactive bladder (OAB) syndrome affect daily lifestyle and sexual activity, especially in women in the most active era in their social and personal life. However, there is lack of data proving the effect of OAB syndrome on sexual activity or sexual life quality in sexually active age group. This study aimed at evaluating the effect of OAB syndrome and UI on the sexual activity and on the sexual quality of life (QoL) of Korean women age from 20s to 40s. We investigated 3372 women aged between 20 and 49 y, enrolled via a multicenter internet survey. A structured questionnaire was used to collect data about their LUTS and sexual activities. The prevalence of OAB syndrome and UI in 3372 women was 12.7 and 21.0%, respectively. Mean subject age was 26.4+/-4.8 y and 79.5% of subjects were 20-29 y old. Having OAB syndrome or UI were found to be significant predictors of sexual life problems (OAB syndrome: OR=5.08, 95% CI=3.68-7.01; UI: OR=4.16, 95% CI=3.06-5.67). Sexual activity was significantly reduced in OAB syndrome and UI versus the asymptomatic group (OAB syndrome: OR=4.8, 95% CI=3.14-6.83; UI: OR=3.9, 95% CI=2.81-5.27). This study is the first internet-based study concerning the sexual QoL in UI and OAB syndrome. In this study, OAB syndrome was found to cause a greater deterioration in the sexual QoL than UI. These results suggest that these symptoms have a significant impact upon women's personal and social lives and markedly affect the QoL.

Adult↗

PubMed2004

Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial.

PURPOSE: Trospium chloride is an anticholinergic agent with predominantly peripheral nonselective antimuscarinic activity lacking central nervous system effects. It has no known drug-drug interactions, an advantage for patients taking many medications. Because these qualities may provide added benefit when treating patients with symptoms associated with overactive bladder (OAB) and urge incontinence, we studied the effectiveness of trospium in treating these conditions. MATERIALS AND METHODS: Patients with OAB with urge incontinence were randomized 1:1 to 20 mg trospium twice daily or placebo in this 12-week, multicenter, parallel, double-blind, placebo controlled trial. Dual primary end points were change in average number of toilet voids and change in urge incontinent episodes per 24 hours. Secondary efficacy variables were change in average of volume per void, voiding urge severity, urinations during day and night, time to onset of action and change in Incontinence Impact Questionnaire. RESULTS: A total of 523 patients were entered at 51 sites. Trospium significantly decreased average frequency of toilet voids and urge incontinent episodes compared to placebo. It significantly increased average volume per void, and decreased average urge severity and daytime frequency. All effects occurred by week 1 and all were sustained throughout the study. Nocturnal frequency decreased significantly by week 4 and Incontinence Impact Questionnaire scores improved at week 12. Trospium was well tolerated. CONCLUSIONS: Trospium was found to have sustained effectiveness beginning at the end of week 1 in decreasing the number of voids, urge incontinent episodes, total daily micturitions and urge severity, and in increasing volume per void. It also improved symptoms of OAB and quality of life.

Benzilates↗

PubMed2005

The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospects.

OBJECTIVE: To review the concept of urinary urgency and its practical measurement in clinical trials, and advance the hypothesis that while urge is experienced by normal people, urgency is always pathological. METHODS: According to the International Continence Society (ICS) definition, urgency is the primary symptom of the overactive bladder (OAB) syndrome, but in clinical trials there are inconsistencies in both the definition and assessment of urgency. We searched the PubMed and BIOSIS databases for publications and abstracts related to the clinical assessment of urgency in patients with OAB. RESULTS: The differentiation of urgency from the normal physiological desire to void is discussed. In clinical studies of OAB, urgency has been measured both qualitatively and quantitatively. Existing qualitative assessment scales for urgency are deficient in accuracy, validation or both, and are largely inconsistent with the currently accepted ICS definition of urgency. The quantitative assessment of urgency by diary entry has been validated and may be the most accurate, reproducible and clinically meaningful method available for measuring this variable. CONCLUSION: Based on the existing ICS definition of urgency as 'a compelling desire to pass urine that is difficult to defer', the concept of qualitative assessment of urgency may be flawed.

Clinical Trials as Topic↗

PubMed2002

Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder.

BACKGROUND: The objective of the present study was to examine the long-term safety, tolerability and efficacy of tolterodine extended-release (ER) in patients who had completed 12 weeks' treatment in a randomised, double-blind study comparing tolterodine ER 4 mg once daily (qd), tolterodine immediate-release (IR) 2mg twice daily and placebo. METHODS: Of the 1377 patients completing the 12-week study, a total of 1077 (78%) chose to continue with 12 months' open-label treatment with tolterodine ER 4 mg once daily, irrespective of their previous treatment. Safety was assessed after 3, 6, 9 and 12 months' treatment in the study. Efficacy was evaluated from micturition diary variables and patients' perception of bladder condition and urgency following 3 and 12 months' treatment. RESULTS: 71% of patients completed the 12-month study. Tolterodine ER was safe and well tolerated. Adverse events of the general (14.5%), autonomic (13.2%), gastrointestinal (11.4%), respiratory (9.8%) and urinary (9.1%) systems were the most frequently reported. Dry mouth was the most common event, occurring in 12.9% of patients, and was generally mild in severity. Other adverse events occurred in less than 5% of patients. There was no increase in the frequency of adverse events with long-term relative to short-term treatment. The efficacy of tolterodine was maintained over the 12-month treatment period; relative to baseline there were reductions in the number of incontinence episodes per week (median change -83%) and micturitions per 24 hours (median change -21%) and an increase in volume voided (median change +25%) after 12 months' treatment. An improvement in patient perception of their bladder condition was found in 75% of patients completing the study, and 51% had an improvement in patient perception of urgency. CONCLUSIONS: Tolterodine ER 4mg qd displayed a favourable safety, tolerability and efficacy profile during 12 months' treatment of patients with overactive bladder.

Adult↗