Con Kelleher

The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well‐being in men and women: results from the EPIC study

To examine the effect overactive bladder (OAB) and other lower urinary tract symptoms (LUTS) on health‐related quality of life (HRQoL) in a population sample, as OAB often occurs in conjunction with many other LUTS.

Multinational study of reliability and validity of the King's Health Questionnaire in patients with overactive bladder

Objective: Overactive bladder (OAB) has substantial impact on health-related quality of life (HRQoL). The purpose of this research was to evaluate the psychometric properties of the Kings Health Questionnaire (KHQ). Methods: The KHQ (n = 1284) was administered at baseline and 12 weeks post-treatment in a multinational, double-blind, randomized clinical trial of tolterodine for treatment of OAB. Country-specific psychometric analyses of HRQoL instruments were performed. Countries demonstrating marginal psychometric properties on the KHQ were pooled with same-language countries, re-evaluated, and aggregate analysis performed on the pooled data. Results: Internal consistency of the KHQ was high, item characteristics were good, most assumptions of summed scales were met, and it is externally valid and consistent. Few problems with the KHQ were noted although the performance of the personal relationships domain was complicated by the ‘not applicable’ response category. Conclusions: Psychometric testing supports the reliability and validity of the KHQ as an OAB-specific measure of HRQoL.

How much is enough and who says so

Background  One of the challenges of health‐related quality of life research is to translate statistically significant health‐related quality of life changes into interpretable clinical or medically important ones.

Combination Treatment with Mirabegron and Solifenacin in Patients with Overactive Bladder: Efficacy and Safety Results from a Randomised, Double-blind, Dose-ranging, Phase 2 Study (Symphony)

BACKGROUND Combining the β3-adrenoceptor agonist mirabegron and the antimuscarinic (AM) agent solifenacin may improve efficacy in the treatment of overactive bladder (OAB) while reducing the AM side effects. OBJECTIVE The primary objective was to evaluate the efficacy of combinations of solifenacin/mirabegron compared with solifenacin 5mg monotherapy. The secondary objective was to explore the dose-response relationship and the safety/tolerability compared with placebo and monotherapy. DESIGN, SETTING, AND PARTICIPANTS A phase 2, factorial design, randomised, double-blind, parallel-group, placebo- and monotherapy-controlled trial, conducted at 141 sites in 20 European countries. Male and female patients were aged ≥18 yr with symptoms of OAB for ≥3 mo. INTERVENTION A total of 1306 patients (66.4% female) were randomised to 12 wk of treatment in 1 of 12 groups: 6 combination groups (solifenacin 2.5, 5, or 10 mg plus mirabegron 25 or 50 mg), 5 monotherapy groups (solifenacin 2.5, 5, or 10 mg, or mirabegron 25 or 50 mg), or placebo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Change from baseline to end of treatment in mean volume voided per micturition (MVV) (primary end point) and mean numbers of micturitions per 24 h, incontinence episodes per 24 h, and urgency episodes per 24 h were analysed using an analysis of covariance model. Safety assessments included treatment-emergent adverse events (TEAEs), blood pressure, pulse rate, postvoid residual (PVR) volume, and laboratory and electrocardiography (ECG) parameters. RESULTS AND LIMITATIONS Compared with solifenacin 5 mg monotherapy, all combinations with solifenacin 5 or 10 mg significantly improved MVV, with adjusted differences ranging from 18.0 ml (95% confidence interval [CI], 5.4-30.0) to 26.3 ml (95% CI, 12.0-41.0). Three combination groups significantly reduced micturition frequency compared with solifenacin 5 mg, ranging from -0.80 (95% CI, -1.39 to -0.22) to -0.98 (95% CI, -1.68 to -0.27). Five of six combinations significantly reduced urgency episodes compared with solifenacin 5 mg, ranging from -0.98 (95% CI, -1.78, to -0.18) to -1.37 (95% CI, -2.03 to -0.70). No dose-related trends in TEAEs, blood pressure, pulse rate, PVR volume, or laboratory or ECG parameters were observed between combination and monotherapy groups, although the incidence of constipation was slightly increased with combination therapy. CONCLUSIONS Combination therapy with solifenacin/mirabegron significantly improved MVV, micturition frequency, and urgency compared with solifenacin 5 mg monotherapy. All combinations were well tolerated, with no important additional safety findings compared with monotherapy or placebo. PATIENT SUMMARY To improve treatment of overactive bladder (OAB), mirabegron/solifenacin in combination was compared with each drug alone and placebo. Combination therapy improved OAB symptoms and had similar safety and acceptability. TRIAL REGISTRATION Clinical trials.gov: NCT01340027.

Improved quality of life in patients with overactive bladder symptoms treated with solifenacin.

To assess the effect of solifenacin succinate treatment on quality of life (QoL) measured in clinical trials in patients with overactive bladder (OAB).

Quality of life and urinary incontinence

Urinary incontinence affects some aspect of the lives of between 15 and 30% of women. The impact of incontinence, however, varies owing to many factors such as age and cultural beliefs. Quality of life assessments now offer both general and specific questionnaires that measure the impact of this deb

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

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).

Overactive Bladder Is Associated with Erectile Dysfunction and Reduced Sexual Quality of Life in Men

INTRODUCTION The prevalence of sexual dysfunction, including erectile dysfunction (ED), is greater in men with lower urinary tract symptoms (LUTS), including overactive bladder (OAB), than in men without LUTS. AIM To evaluate the prevalence of ED, the impact of urinary symptoms on sexual activity and sexual enjoyment, and sexual satisfaction in men with OAB. METHODS A nested case-control analysis was performed on data from a subset of men with (cases) and without (controls) OAB frequency-matched for age (5-year age strata) and country from the EPIC study. Respondents were asked about OAB symptoms (using the 2002 International Continence Society [ICS] definitions) and sexual activity. Sexually active respondents were asked about ED, sexual enjoyment, and overall satisfaction with their sex lives. Conditional logistic regression was used to assess factors associated with ED. MAIN OUTCOME MEASURES The percentage of cases and controls reporting ED, a reduction in the frequency of sexual activity or enjoyment of sexual activity because of urinary symptoms, and overall satisfaction with their sex lives was determined for cases and controls. RESULTS A total of 502 cases and 502 controls were matched for age strata and country. Significantly more cases (14%) reported reduced sexual activity because of urinary symptoms compared with controls (4%; P <or= 0.05). Among sexually active respondents, cases were significantly more likely to have ED than were controls (prevalence odds ratio, 1.5; 95% confidence interval, 1.1-2.2); the prevalence of ED was similar to that for men with hypertension or diabetes. Significantly more cases (15%) reported decreased enjoyment of sexual activity because of urinary symptoms relative to controls (2%; P <or= 0.05), and significantly fewer cases were satisfied with their sex lives (81% vs. 90%; P <or= 0.05). CONCLUSIONS OAB, as defined by the ICS, was significantly associated with increased prevalence of ED, reduced sexual activity and sexual enjoyment because of urinary symptoms, and reduced sexual satisfaction.

Overactive bladder syndrome in older people

The overactive bladder symptom complex (OAB) is the commonest cause of urinary incontinence in older people, and is usually due to underlying detrusor overactivity, and as such is a treatable condition. Older people are a heterogeneous group, which includes fit community‐dwelling individuals and those with significant medical comorbidity; thus the requirements of care for this group are many and varied. The International Continence Society definition of the frail elderly, those aged >65 years with continence problems, who by virtue of comorbidity are house‐bound or living in an institution, is clearly not applicable to all. However, many conditions begin to appear in later life and practitioners need to be aware of the need to manage these, and their treatment, when dealing with older people. Studies of medication for OAB have included the elderly and there is evidence of an equivalent benefit in younger people. The impact of treatment on the cognitively impaired and those receiving acetylcholinesterase inhibitors is discussed.

Impact of fesoterodine on quality of life: pooled data from two randomized trials

To evaluate the effect of fesoterodine on health‐related quality of life (HRQoL) in patients with overactive bladder (OAB) syndrome.