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PubMed2006

Epidemiology, prescribing patterns and resource use associated with overactive bladder in UK primary care.

This study aimed to estimate the incidence and prevalence of overactive bladder (OAB) symptoms in the UK and analyse the use of anticholinergic/antispasmodic medications and other healthcare resources within UK general practice. Patients with a record of urinary frequency, urgency, nocturia, urge incontinence or irritable/unstable bladder between 1987 and 2004 were identified from the General Practice Research Database. Demographic characteristics, referrals, consultations, investigations and prescriptions for medications licensed for use in OAB were identified. Regression analyses were used to identify the factors determining switches between medications, referrals and use of healthcare resources. The overall prevalence of OAB-related symptoms was 3.87 per 1000 persons, with an incidence of 2.79 per 1000 person-years. Among 68,910 patients with OAB symptoms, 19,444 (28.2%) received anticholinergic medication, of whom 14,454 (74.3%) received one drug and 4055 (20.9%) received two medications sequentially. Overall, 59.1% of patients were referred to relevant secondary care specialities, 2.8% underwent urinary tests/investigations in primary care and 0.2% were seen by a continence nurse. Resource use was higher among patients who tried several different medications. In conclusion, this study suggests that OAB may be under-diagnosed in the UK and that current guidelines recommending use of anticholinergic medication, continence nurse consultations and urinary tests/investigations are inadequately followed.

Cholinergic Antagonists↗

PubMed2002

Efficacy of physical therapeutic modalities in women with proven bladder overactivity.

OBJECTIVE: To assess the efficacy of physiotherapeutic treatment modalities in women with proven bladder overactivity. METHODS: One hundred and twelve women received ambulatory urodynamics. Based on both urodynamic variables of ambulatory cystometry (ACM) and the micturition diary, the Detrusor Activity Index (DAI) for each patient was calculated. After randomization, 68 women with a DAI> or =0.50 were defined as having proven bladder overactivity. In a single blinded RCT patients were randomized over four treatment groups, i.e. lower urinary tract exercises (LUTE); office- and home-based functional electrostimulation (FES); office-based FES and LUTE; no treatment. Patients treated received nine treatment sessions, once weekly. The primary outcome variable was the DAI, measured before randomization and, as soon as possible within a maximum of 14 days after the end of the study period. RESULTS: Intention to treat analysis in the group of 68 patients showed a statistically significant decrease of DAI-scores in the FES group (p=0.032) in comparison with no treatment, while this decrease was not statistically significant in the LUTE group (p=0.105) and the LUTE+FES group (p=0.672). CONCLUSIONS: Our conclusion is that, based on the DAI, in the homogeneous set of 68 patients, only FES seemed to be effective.

Adult↗

PubMed2006

Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study.

OBJECTIVE: To assess health-related quality-of-life (HRQoL) and safety with the oxybutynin transdermal system (OXY-TDS) (Oxytrol), Watson Pharma, Corona, CA, USA) in the Multicentre Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin (MATRIX) study, as HRQoL measurements are increasingly important in evaluating pharmacotherapy for overactive bladder (OAB). PATIENTS AND METHODS: This randomized, open-label, community-based study enrolled 2878 participants aged >/=18 years who had been given a diagnosis of OAB. The 327 study sites were representative of various practice types. All participants were treated with OXY-TDS 3.9 mg/day for </=6 months. HRQoL was assessed using the King's Health Questionnaire (KHQ); the primary endpoint was the change in KHQ scores from baseline to study end. RESULTS: Most enrolees (2052/2625; 78.2%) had moderate to severe OAB at baseline (Patient Perception of Bladder Condition score >/= 4 on a scale of 1-6), and most (1632/2859; 57.1%) had been given previous drug treatment for OAB. Of 2592 with evaluable baseline KHQ scores, 92.2% reported urgency and 88.2% reported urge urinary incontinence. The most impaired domains at baseline were Incontinence Impact (69.3), Symptom Severity (55.9), and Sleep/Energy (54.2). There were clinically meaningful and statistically significant improvements in nine of 10 domains at the study end; the greatest improvements were in Incontinence Impact (-13.5), Symptom Severity (-12.4), and Role Limitations (-13.3). The treatment was well tolerated, with low incidences of drug-related anticholinergic adverse effects such as dry mouth (75; 2.6%), constipation (44; 1.5%), and dizziness (21; 0.7%). There were drug-related application-site reactions, including pruritus, erythema, dermatitis and irritation, in 14.0% of participants. CONCLUSIONS: OXY-TDS treatment was well tolerated in this diverse, community-based population, and resulted in clinically significant improvements in HRQoL, regardless of baseline characteristics.

Administration, Cutaneous↗

PubMed1998

Surgery for the treatment of overactive bladder.

OBJECTIVES: To describe surgical options that may be indicated when conservative management of overactive bladder is unsuccessful. METHODS: The literature on current endoscopic and open surgical procedures is reviewed. RESULTS: The endoscopic approach of hydrodistention under anesthesia may be therapeutic, but normally offers only temporary relief of symptoms. Among open surgical procedures, cystolysis has not withstood the test of time and is no longer used. Partial rhizotomy can reduce reflex bladder contractility while preserving other important urogenital functions. Peripheral denervation via a vaginal approach appears effective in as many as 70% of patients with motor instability, but is not effective in interstitial cystitis or other sensory bladder disorders. Transvesical phenol injection is most effective for detrusor instability (DI) caused by multiple sclerosis. Enterocystoplasty is more helpful in intractable DI than in interstitial cystitis. Detrusor myomectomy has yielded excellent results in patients with neurogenic causes of DI. Urinary diversion is rarely required in DI, but may be preferable to enterocystoplasty when severe pelvic pain is present. CONCLUSIONS: When appropriately chosen, surgical procedures can substantially improve the quality of life of some individuals with overactive bladder.

Cystoscopy↗

PubMed2003

[Overactive bladder--treatment with antimuscarinic agents].

Today, urgency and urge incontinence are both defined under the topic overactive bladder (OAB) whereby pure urge syndrome (pollakisuria, nocturia, and urgency) can easily lead to urge incontinence. Antimuscarinics still constitute the domain of treatment for overactive bladder. The pharmacological effect of modern substances consists of M2 or M3 muscarinic receptor blockade. This blockade prevents acetylcholine from connecting to these receptors and thus leads to a weakness or prevention of the detrusor muscle contraction. These groups of drugs are defined as muscarinic receptor antagonists, antimuscarinics, or anticholinergics. In addition to the muscarinic receptors, some drugs directly block the calcium channels in the cell membrane (calcium antagonists) which are classified as drugs with mixed effect. The presented paper gives an overview about the existing data on drugs approved in Germany whose clinical effect has been proven in randomized studies or are have stood the test of time in daily clinical practice.

Calcium Channel Blockers↗

PubMed2006

The natural history of overactive bladder and stress urinary incontinence in older women in the community: a 3-year prospective cohort study.

AIMS: This is the first study designed to describe the natural history of stress urinary incontinence (SUI) and overactive bladder (OAB), using validated symptom syndrome severity scores developed for the purpose. METHODS: Two separate but related studies were involved, (i) a clinic sample (N = 2,052) from a randomised controlled trial (RCT) and (ii) a prospective cohort study (N = 12,750) with 3-year follow-up. Subjects in both studies were women aged 40 or more living in the community, approached using similar postal questionnaires. Severity scores using standardised urinary symptoms were derived for SUI and OAB from weightings obtained from logistic regression models of symptoms in relation to urodynamic diagnosis. Symptom severity scores were plotted for baseline and 3 years of follow-up to demonstrate the natural history of the main categories of SUI and OAB. RESULTS: Overactive bladder and SUI syndrome severity scores showed good criterion validity in relation to relevant clinical measures and good test-retest reliability. OAB severity increased progressively with age including a period of accelerated increase in the 60s. In contrast, SUI severity showed two age-related peaks around age 60 and again at age 80. SUI severity also showed a more fluctuating pattern from year to year compared to OAB. CONCLUSIONS: Contrasting patterns of natural history for OAB and SUI syndromes were identified consistent with differences in the patterns of related co-morbidities. Further studies are needed to confirm these findings.

Adult↗

PubMed2007

Relationships among symptoms, bother, and treatment satisfaction in overactive bladder patients.

AIMS: We have studied the association between various symptoms, bother, and patient treatment satisfaction in overactive bladder (OAB). METHODS: Episodes of urgency, incontinence, daytime frequency and nocturia and responses to the patient perception of bladder condition scale, the urgency perception scale, and visual analog scales of limitations in daily life and of treatment satisfaction were evaluated in 3,824 OAB patients at baseline and during 9 months treatment with tolterodine ER (4 mg q.d.) in an open-label, observational study. Relationships amongst number of symptoms/ 24 hr and scales were explored. Treatment satisfaction was correlated with improvements in symptoms and scales. RESULTS: At baseline, the number of episodes of the four OAB symptoms correlated only poorly with each other and with the two bother-related scales, while the two scales assessing bother correlated much stronger with each other. Factor analysis identified four components which described "bother," "incontinence," "urgency/frequency," and "nocturia" and in combination explained 81.9% of the total variance. The component "bother" had the strongest individual effect accounting for 42.1% of the total variance. While improvements of symptoms and bother were seen with tolterodine treatment, patient treatment satisfaction correlated strongest with improvements of the two bother-related scales. CONCLUSIONS: We conclude that the counting of episodes of OAB symptoms only insufficiently describes the afflicted patients. Patient bother is the strongest individual component but only poorly explained by episodes of the four symptoms defining OAB. Alterations of bother may better reflect patient-relevant outcomes in OAB treatment than alterations in the number of symptom episodes.

Adult↗

PubMed2006

The current and future burden and cost of overactive bladder in five European countries.

OBJECTIVE: To estimate and compare the current and future direct cost of overactive bladder (OAB) to the health care systems of five European countries. METHOD: A health economic model was created to estimate the number of people currently affected by OAB symptoms, the expected number to be affected in the future, and the resultant economic burden on health care systems in Germany, Italy, Spain, Sweden, and the United Kingdom. RESULTS: The model estimated that in 2000, 20.2 million people over age 40 in the five countries experienced the symptoms of OAB; 7 million of these had urgency with urge incontinence. This figure is expected to rise to 25.5 million by 2020, including 9 million who will have urgency with urge incontinence. Average annual direct costs of OAB management ranged from euro269 to euro706 per patient per year. The largest cost was the use of incontinence pads, accounting for an average of 63% of the annual per patient cost of OAB management. Total cost to health care systems across all five countries was estimated at euro4.2 billion in 2000, and by 2020, the expected total cost was estimated to be euro5.2 billion, an increase of euro1 billion (26%). CONCLUSION: OAB is prevalent, with a substantial direct cost that is anticipated to increase in the future in line with aging populations. The overall burden, including indirect costs, may be considerably larger, and will fall predominantly on the elderly OAB population with urge incontinence. Recommended medical treatments could help manage those costs and should be evaluated.

Adult↗

PubMed2006

Symptom-specific efficacy of tolterodine extended release in patients with overactive bladder: the IMPACT trial.

We evaluated the efficacy of tolterodine extended release (ER) for patients' most bothersome overactive bladder (OAB) symptom in a primary care setting. Patients with OAB symptoms for >or=3 months received tolterodine ER (4 mg q.d.) for 12 weeks. Among incontinent patients (n = 772), the most bothersome OAB symptoms were daytime frequency (28%), urgency urinary incontinence (UUI; 27%), nocturnal frequency (26%) and urgency (19%); among continent patients (n = 91), they were daytime frequency (47%), nocturnal frequency (42%) and urgency (10%). Sixty-nine per cent of patients had one or more comorbid conditions. By week 12, there were significant reductions in patients' most bothersome symptom: -80% for UUI, -78% for urgency episodes, -40% for nocturnal frequency and -30% for daytime frequency (p < 0.0001). The most common adverse events were dry mouth (10%) and constipation (4%). In primary care practice, bothersome OAB symptoms can be effectively and safely treated with tolterodine ER, even in patients with comorbid conditions.

Adult↗

PubMed2006

Pharmacoeconomic evaluation of antimuscarinic agents for the treatment of overactive bladder.

STUDY OBJECTIVE: To compare the cost-effectiveness of various antimuscarinic agents for the treatment of overactive bladder (OAB). METHODS: A decision-analysis model was developed and included clinical outcomes (i.e., therapy continued or discontinued, treatment success or failure, OAB-induced comorbidities) and costs for drugs and treatment of OAB-induced comorbidities (i.e., urinary tract infections, fractures, depression, and skin infections). Treatment success was defined as complete continence. A systematic MEDLINE literature search from January 1990-January 2006 identified English-language articles concerning the eight antimuscarinic drugs: darifenacin, solifenacin, trospium, immediate-release oxybutynin, extended-release oxybutynin, transdermal oxybutynin, immediate-release tolterodine, and extended-release tolterodine. Probabilities and cost data for these drugs were retrieved from the literature, and drug costs were based on 2005 average wholesale prices. The analysis was constructed from a payer's perspective. The time frame for the model was 3 months. RESULTS: Expected costs for each patient with OAB ranged from $3373 when treated with solifenacin to $3769 when treated with immediate-release oxybutynin. The average cost/patient with continued and successful treatment was lowest for solifenacin ($6863). Solifenacin dominated all other antimuscarinic agents because they were associated with high costs and low effectiveness. Success rates were the key parameters driving the sensitivity analysis. CONCLUSION: Among various antimuscarinic agents, solifenacin 5 mg had the lowest costs and highest effectiveness in the treatment of OAB.

Cost-Benefit Analysis↗

PubMed2004

Potassium channel subtypes as molecular targets for overactive bladder and other urological disorders.

Potassium channels have re-emerged as attractive targets for overactive bladder and other urological diseases in recent years, in part due to an enhanced understanding of their molecular heterogeneity, tissue distribution, functional roles and regulation in physiological and pathological states. Cloning and heterologous expression analysis, coupled with the advancement of improved high-throughput screening techniques, have enabled expeditious identification of selective small-molecule openers and blockers for ATP-sensitive K+ channels, Ca2+-activated K+ channels and voltage-dependent K+ channel-KQT-like subfamily (KCNQ) members, and has paved the way in the assessment of efficacy and adverse effects in preclinical models. This review focuses on the rationale for molecular targeting of K+ channels, the current status of target validation, including preclinical proof-of-concept studies, and provides perspectives on the limitations and hurdles to be overcome in realising the potential of these targets for diverse urological indications such as overactive bladder, erectile dysfunction and prostate diseases.

Aged↗

PubMed2003

Overactive bladder inhibition in response to pelvic floor muscle exercises.

A recent study by the senior author demonstrated that striated urethral sphincter contraction effected the inhibition of vesical contraction and suppression of the desire to micturate, an action suggested to be mediated through the "voluntary urinary inhibition reflex". We hypothesized that the effect of pelvic floor muscle (PFM) exercises on the overactive bladder was mediated through this reflex action. The current communication investigates this hypothesis. A total of 28 patients (mean age 44.8+/-10.2 years, 18 men, 10 women) with overactive bladder and 17 healthy volunteers (mean age 42.6+/-9.8 years, 12 men, 5 women) were enrolled in the study. The vesical and posterior urethral pressures were determined before and after vesical filling reached the volume at which urge in control subjects, and involuntary voiding in the patients, occurred. Intra-abdominal pressure was recorded to obtain detrusor pressure readings. The bladder was refilled to the above volume and the subject asked to hold PFM contractions for 10 s during which the vesical and posterior urethral pressures were recorded. In healthy volunteers, the mean detrusor and posterior urethral pressures at urge to void were 30.6+/-4.8 SD and 18.7+/-3.3 cm H(2)O, respectively. On PFM contraction, the detrusor pressure declined to 11.6+/-1.4 cm H(2)O (P<0.01) and urethral pressure increased to 139.8+/-17.4 cm H(2)O (P<0.001). In patients, the mean detrusor and posterior urethral pressure readings when the bladder was filled to the volume which induced involuntary incontinence, were 28.2+/-4.2 and 17.3+/-3.4 cm H(2)O, respectively; on PFM contractions, the detrusor pressure decreased to 10.6+/-2.1 cm H(2)O (P<0.01), while urethral pressure increased to 86.6+/-7.9 cm H(2)O (P<0.001) and voiding did not occur. In conclusion, PFM contractions led to a decline of detrusor and increase of urethral pressures and suppressed the micturition reflex. These contractions appear to induce their effect by preventing internal sphincter relaxation produced by the micturition reflex. Failure of the internal sphincter to relax seems to cause reflex detrusor relaxation, an action presumably mediated through the "voluntary urinary inhibition reflex". The results of the current study encourage the treatment of overactive bladder with PFM contractions.

Adult↗

PubMed2006

Current and future trends in the management of overactive bladder.

Urinary incontinence is a common problem which increases in prevalence in association with advancing age and has a significant adverse effect upon well-being and quality of life. It is not the "benign" condition that many take it for. Overactive bladder (frequency-urgency syndrome) is the commonest bladder problem in late life, affecting up to 41% of over-75-year-old individuals, and the elderly experience more severe disease. This small series should provide the reader with a comprehensive overview of the current thinking in the assessment and management of patients with overactive bladder syndrome, explores the history of the condition and current approaches to its medical and surgical management and explores where management may change in more complex populations. The current state and future developments in pharmacological therapy are also outlined.

Aged↗

PubMed2003

Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial.

OBJECTIVE: To compare the efficacy and tolerability of extended-release formulations of oxybutynin chloride and tolterodine tartrate in women with overactive bladder. PATIENTS AND METHODS: The OPERA (Overactive bladder: Performance of Extended Release Agents) trial was a randomized, double-blind, active-control study performed at 71 US study centers from November 21, 2000, to October 18,2001. Extended-release formulations of oxybutynin at 10 mg/d or tolterodine at 4 mg/d were given for 12 weeks to women with 21 to 60 urge urinary incontinence (UUI) episodes per week and an average of 10 or more voids per 24 hours. Episodes of UUI (primary end point), total (urge and nonurge) incontinence, and micturition were recorded in 24-hour urinary diaries at baseline and at weeks 2, 4, 8, and 12 and compared. Adverse events were also evaluated. RESULTS: Improvements in weekly UUI episodes were similar for the 790 women who received extended-release formulations of oxybutynin (n = 391) or tolterodine (n = 399). Oxybutynin was significantly more effective than tolterodine in reducing micturition frequency (P = .003), and 23.0% of women taking oxybutynin reported no episodes of urinary incontinence compared with 16.8% of women taking tolterodine (P = .03). Dry mouth, usually mild, was more common with oxybutynin (P = .02). Adverse events were generally mild and occurred at low rates, with both groups having similar discontinuation of treatment due to adverse events. CONCLUSIONS: Reductions in weekly UUI and total incontinence episodes were similar with extended-release formulations of oxybutynin and tolterodine. In the oxybutynin group, micturition frequency was significantly lower, and the percentage of women reporting no urinary incontinence episodes was significantly higher compared with the tolterodine group. Dry mouth was more common with oxybutynin, but tolerability was otherwise comparable, including adverse events involving the central nervous system.

Administration, Oral↗

PubMed2006

Efficacy and tolerability of tolterodine extended release in male and female patients with overactive bladder.

OBJECTIVES: To evaluate the efficacy and tolerability of tolterodine extended release (ER) in men and women with overactive bladder (OAB). METHODS: We analyzed data from two 12-wk, placebo-controlled trials of tolterodine ER (4mg QD). Patients completed 7-d bladder diaries and rated the urgency sensation associated with each micturition on a 5-point urgency rating scale. Micturitions were categorized by urgency rating: total (1-5), non-OAB (1-2), OAB (3-5), or severe OAB (4-5). Changes in micturitions during 24-h, daytime, and nocturnal intervals were assessed. RESULTS: At baseline, 73% (547 of 745) of men and 57% (539 of 953) of women were continent. By week 12, tolterodine ER (n=848) reduced OAB and severe OAB micturitions during 24-h, daytime, and nocturnal intervals in both sexes compared with placebo (n=850). Adverse event rates were low and similar across treatment and gender. CONCLUSIONS: In men and women with OAB, tolterodine ER reduced OAB and severe OAB micturitions, and was well tolerated.

Benzhydryl Compounds↗

PubMed2006

Solifenacin provides effective antimuscarinic therapy for the complete management of overactive bladder.

Solifenacin is an antimuscarinic agent, administered once daily, which has been newly approved for the treatment of overactive bladder (OAB). Solifenacin administered at 5- and 10-mg once-daily doses shows efficacy for all the symptoms of OAB in both 'wet' and 'dry' patients, including improvements in patient quality of life and satisfaction. These improvements are observed as early as week 2 of treatment and are maintained over 12-week and 1-year time periods, without being compromised by the age or gender of the patient. Solifenacin demonstrates a favourable tolerability profile, with mild dry mouth as the most common adverse event associated with its use, both at the 5- and 10-mg doses; this allows for flexibility in the dosing regimen, in which physicians can administer solifenacin 5 mg, with the option to safely increase the dose to 10 mg if necessary based on the severity of patient's symptoms. The favourable efficacy and safety profile of solifenacin, coupled with its dose flexibility, are consistent with solifenacin being a convenient treatment option for patients with OAB.

Dose-Response Relationship, Drug↗

PubMed2006

Refractory overactive bladder in men: update on novel therapies.

Overactive bladder (OAB) in men is an entity that may be challenging to diagnose and treat, especially in the presence of bladder outlet obstruction. The application of oral medical treatments of lower urinary tract symptoms attributed to benign prostatic hyperplasia has traditionally utilized alpha-adrenergic blockers and 5alpha-reductase inhibitors. After failure of oral medical therapies, surgical options are traditionally offered. Even after surgical options are successful, lower urinary tract symptoms that are secondary to OAB persist. These patients merit a trial of antimuscarinic drugs. Additionally, certain patients with concomitant bladder outlet obstruction who have not been surgically relieved can still merit a trial of antimuscarinic drugs without significant risk of developing urinary retention. When these oral antimuscarinic drugs fail, options still remain for treating men with refractory OAB. Successful application of various diagnostic approaches and the initiation of conservative options as well as other options, such as neuromodulation for refractory urgency and urge incontinence, can help the patient. Finally, emerging data support the use of intradetrusor injections of botulinum toxin for refractory OAB.

Cholinergic Antagonists↗

PubMed2004

Comparison of symptom severity and treatment response in patients with incontinent and continent overactive bladder.

PURPOSE: Two thirds of patients with overactive bladder (OAB) are continent, but our knowledge on the treatment of the syndrome is largely based on studies with incontinent patients. Therefore, we have explored baseline symptoms and treatment responses to tolterodine in continent relative to incontinent OAB patients. MATERIALS AND METHODS: Data from an open-label, observational study involving 3824 patients with OAB symptoms were analyzed for baseline symptoms and alterations thereof upon a 9 months treatment with 4 mg q.d. tolterodine ER. RESULTS: Baseline symptoms (number of urgency episodes, total urination frequency, daytime frequency, nocturia, and three scales of OAB severity) were similar in 1147 continent and 2571 incontinent patients, the latter having 4.8+/-3.7 incontinence episodes per 24 h. Tolterodine ER-induced reduction of OAB symptoms was very similar in both groups of patients. CONCLUSIONS: The severity of OAB in continent patients can be similar to that in incontinent ones. Symptom improvement upon treatment with tolterodine ER is very similar in both groups. We propose that continent patients may similarly deserve treatment with a muscarinic receptor antagonist as incontinent ones.

Aged↗