Finding unrecognized information in overactive bladder clinical trial data: a new approach to understanding placebo and treatment effects.

Aims: To identify combinations of variables among overactive bladder (OAB) clinical trial subjects that allow prediction of those who are more--or less--likely to respond strongly to placebo, or to medication.

Methods: Data from two Phase IIIb clinical trials of solifenacin in OAB were combined. Predictive models for placebo and treatment responses were constructed using baseline variables including individual items from the OAB questionnaire.

Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial.

Aims: The primary objective was to investigate the efficacy of desmopressin orally disintegrating tablet versus placebo in patients with nocturia. Pharmacodynamics, safety and patient-reported quality of life (QoL) outcomes were also evaluated. One of several benefits of the new formulation is increased bioavailability.

Once-daily trospium chloride 60 mg extended-release provides effective, long-term relief of overactive bladder syndrome symptoms.

Aims: Once-daily extended-release (XR) trospium chloride has been evaluated for the treatment of overactive bladder syndrome (OAB) in two 12-week randomized, double-blind, placebo-controlled studies. This pooled analysis of the 9-month open-label extensions to these studies evaluated the long-term efficacy and tolerability of trospium XR.

Methods: Following double-blind treatment, subjects with OAB could enter the open-label period, during which they received trospium 60 mg XR once daily for 36 weeks.

Trospium chloride extended release is effective and well tolerated in women with overactive bladder syndrome.

Introduction And Hypothesis: To confirm the efficacy and tolerability of extended release (ER) trospium chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed.

Methods: Adults (aged > or = 18 years) who had OAB with urinary urgency, frequency, and urge urinary incontinence (UUI) were randomized to trospium ER 60 mg or placebo once daily for 12 weeks. The analysis included 989 women (trospium ER, n = 484; placebo, n = 505).

Trospium 60 mg once daily (QD) for overactive bladder syndrome: results from a placebo-controlled interventional study.

Objectives: A once-daily (QD) formulation of trospium chloride has been developed for the management of overactive bladder syndrome (OAB). This randomized controlled trial evaluated the efficacy and tolerability of this new extended-release formulation, trospium chloride 60 mg QD.

Methods: Adults with OAB with urinary urgency, frequency, and urgency urinary incontinence (UUI) were eligible for inclusion.

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

The International Continence Society has defined overactive bladder (OAB) as urinary urgency, with or without urge urinary incontinence, usually with urinary frequency and nocturia. Approximately 17% of men and women in the US report OAB symptoms, which can affect quality of life. Trospium chloride, which has recently been introduced in the US as Sanctura, has been prescribed for > 10 years in Europe as, for example, Spasmo-lyt, Regurin and Spasmex.

Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer.

Purpose: To describe the natural history of nonmetastatic prostate cancer and rising prostate-specific antigen (PSA) despite androgen deprivation therapy.

Patients And Methods: The 201 patients in this report were the placebo control group from an aborted randomized controlled trial to evaluate the effects of zoledronic acid on time to first bone metastasis in men with prostate cancer, no bone metastases, and rising PSA despite androgen deprivation therapy. Relationships between baseline covariates and clinical outcomes were assessed by Cox proportional hazard analyses.

Similar frequency of testosterone surge after repeat injections of goserelin (Zoladex) 3.6 mg and 10.8 mg: results of a randomized open-label trial.

Objectives: To investigate whether testosterone surges occur on repeat injections of 3.6 or 10.8 mg goserelin (Zoladex) depot and, if so, their extent.

Urinary Side Effects of Duloxetine in the Treatment of Depression and Stress Urinary Incontinence.

BACKGROUND: The efficacy and safety of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine at the recommended starting dose, have been demonstrated in the treatment of major depressive disorder (MDD) in men and women and in the treatment of stress urinary incontinence (SUI) in women. Since the mechanism of action of duloxetine in the treatment of SUI is believed to be related to enhanced urethral closure forces, it is important to clarify the risk of acute urinary retention. METHOD: The relationship between duloxetine and obstructive voiding symptoms was examined in 8 double-blind, 8- to 9-week, placebo-controlled studies and 1 open-label study in men and women treated for MDD with duloxetine 40 to 120 mg/day and in 4 double-blind, 12-week, placebo-controlled studies and 4 ongoing open-label studies in women treated for SUI with duloxetine 80 mg/day.

Pharmacotherapy for stress urinary incontinence : present and future options.

Stress urinary incontinence (SUI) is the accidental leakage of urine associated with physical activities such as running, jumping or lifting, or with sneezing and coughing. Worldwide, SUI is a highly prevalent condition, both in young and elderly women, and is a condition fraught with social isolation, loss of self-esteem and significant financial burden. Most women with SUI assume that it is an inevitable part of aging and "suffer in silence", relying on absorbent pads or lifestyle changes to cope with their condition.

Duloxetine versus placebo for the treatment of North American women with stress urinary incontinence.

Purpose: Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, increases rhabdosphincter contractility via the stimulation of pudendal motor neuron alpha-1 adrenergic and 5-hydroxytryptamine-2 receptors. In this first phase 3 study we assessed the efficacy and safety of duloxetine in women with stress urinary incontinence (SUI).

Materials And Methods: A total of 683 North American women 22 to 84 years old were enrolled in this double-blind, placebo controlled study.

Duloxetine: a serotonin-noradrenaline re-uptake inhibitor for the treatment of stress urinary incontinence.

Stress urinary incontinence (SUI) is the accidental leakage of urine associated with physical activities such as running, jumping or lifting or with sneezing and coughing. For many patients it can be a very bothersome symptom, causing social isolation, loss of self-esteem and increased financial outlays. Although there is currently no medication approved worldwide for the treatment of SUI, a variety of off-label agents are sometimes prescribed.

Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence.

Objectives: To compare the efficacy and safety of an oxybutynin transdermal delivery system (OXY-TDS) and oral, long-acting tolterodine (TOL-LA) with placebo in previously treated patients with urge or mixed urinary incontinence.

Methods: After withdrawal of their current antimuscarinic therapy, 361 adult patients were randomized to 12 weeks of double-blind, double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day, daily TOL-LA 4 mg, or placebo.

Mixed urinary incontinence symptoms: urodynamic findings, incontinence severity, and treatment response.

Objective: To investigate the relationship between the symptom of mixed urinary incontinence and incontinence severity, urodynamic findings, and treatment response.

Methods: This is a secondary analysis of data from 553 women randomized into a double-blind, placebo-controlled study evaluating duloxetine (serotonin-norepinephrine reuptake inhibitor) for the treatment of predominant stress urinary incontinence. Assessment variables included incontinent episode frequency, the Incontinence Quality of Life Questionnaire (I-QOL), and the Patient Global Impression of Severity Scale (PGI-S).

Efficacy and safety of transdermal oxybutynin in patients with urge and mixed urinary incontinence.

Purpose: We evaluated the efficacy and safety of an oxybutynin transdermal delivery system (TDS) in a general population of patients with overactive bladder and urge or mixed urinary incontinence.

Materials And Methods: Following symptom stabilization or treatment withdrawal 520 adult patients were randomized to 12 weeks of double-blind daily treatment with 1.3, 2.

Duloxetine versus placebo in the treatment of stress urinary incontinence.

Objective: The purpose of this study was to assess the efficacy and safety of duloxetine, a selective inhibitor of serotonin and norepinephrine reuptake, in the treatment of stress urinary incontinence.

Study Design: A double-blind, randomized, placebo-controlled study was conducted in 553 women aged 18 to 65 years with a predominant symptom of stress urinary incontinence. Subjects were randomized to placebo (n = 138 women) or duloxetine at one of three doses (20 mg/d, n = 138 women; 40 mg/d, n = 137 women; or 80 mg/d, n = 140 women).

Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients.

Objectives: To evaluate the efficacy, safety, and tolerability of a new, once-daily extended-release (ER) formulation of tolterodine in treating overactive bladder in older (> or =65) and younger (<65) patients.

Design: A 12-week double-blind, placebo-controlled clinical trial.

Setting: An international study conducted at 167 medical centers.

Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies.

This is the first report of the International Continence Society (ICS) on the development of comprehensive guidelines for Good Urodynamic Practice for the measurement, quality control, and documentation of urodynamic investigations in both clinical and research environments. This report focuses on the most common urodynamics examinations; uroflowmetry, pressure recording during filling cystometry, and combined pressure-flow studies. The basic aspects of good urodynamic practice are discussed and a strategy for urodynamic measurement, equipment set-up and configuration, signal testing, plausibility controls, pattern recognition, and artifact correction are proposed.