Do patient characteristics predict responsiveness to treatment of overactive bladder with antimuscarinic agents?

Objective: To determine clinical and demographic characteristics associated with antimuscarinic treatment response using a regression model.

Methods: Adults with overactive bladder (OAB) symptoms for >3 months and ≥ 1 urgency urinary incontinence (UUI) episode and ≥ 8 micturitions per 24 hours at baseline were randomized to fesoterodine (8 mg), tolterodine extended-release (4 mg), or placebo in two 12-week, double-blind, head-to-head studies. Fesoterodine-treated patients received 4 mg/d during the first week and 8 mg/d thereafter.

Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial.

Objective: To assess the superiority of fesoterodine 8 mg vs 4 mg for improvement in urgency urinary incontinence (UUI) episodes and other diary variables, diary-dry rate (proportion of patients with >0 UUI episodes on baseline diary and 0 UUI episodes on post-baseline diary), and improvements in measures of symptom bother, health-related quality of life (HRQL), and other patient-reported outcomes (PROs).

Patients And Methods: This was a 12-week, randomised, double-blind, placebo-controlled, multinational trial of men and women aged ≥18 years with overactive bladder (OAB) symptoms including UUI (ClinicalTrials.gov ID NCT01302067).

A comparison of nonparametric and parametric methods to adjust for baseline measures.

When analyzing the randomized controlled trial, we may employ various statistical methods to adjust for baseline measures. Depending on the method chosen to adjust for baseline measures, inferential results can vary. We investigate the Type 1 error and statistical power of tests comparing treatment outcomes based on parametric and nonparametic methods.

Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial.

Purpose: We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence.

Materials And Methods: In this 12-week, randomized, double-blind, flexible dose, placebo controlled trial, subjects were community dwelling men and women 65 years old or older. Subjects had scores of 3 or more on the VES-13 (Vulnerable Elders Survey) and 20 or more on the MMSE (Mini-Mental State Examination), and 2 to 15 urgency urinary incontinence episodes and 8 or more micturitions per 24 hours on 3-day baseline diaries.

The effect of elective sham dose escalation on the placebo response during an antimuscarinic trial for overactive bladder symptoms.

Purpose: We analyzed the effects of baseline symptom severity and placebo response magnitude on the decision to dose escalate in a 12-week, randomized, double-blind, flexible dose antimuscarinic trial of subjects with overactive bladder symptoms.

Materials And Methods: Data from the placebo arm of the trial were used for this post hoc analysis. Subjects could elect dose escalation at week 2.

Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder.

Aims: To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study.

Methods: Subjects were randomized to fesoterodine 4  mg or placebo. At week 2, subjects could remain on 4  mg (non-escalators) or choose to increase to 8  mg (escalators) for the remaining 10 weeks (sham escalation for placebo).

Effects of combined behavioral intervention and tolterodine on patient-reported outcomes.

Objective: To assess the effects of tolterodine extended release (ER) plus behavioral intervention on urgency and other patient-reported outcomes in subjects with overactive bladder (OAB) who were previously dissatisfied with antimuscarinic treatment.

Methods: In this 16-week, multicenter, open-label study, eligible adults (aged > or = 18 y) reported dissatisfaction with their most recent antimuscarinic OAB medication; > or = 8 micturitions and > or = 2 urgency episodes per 24 hours and > or = 1 UUI episode in 5 day bladder diaries; and OAB symptoms for > or = 3 months. Subjects received tolterodine ER plus a behavioral educational handout with verbal reinforcement of behavioral intervention content for 8 weeks.

Randomized, double-blind, placebo-controlled trial of flexible-dose fesoterodine in subjects with overactive bladder.

Objectives: To evaluate the efficacy and tolerability of flexible-dose fesoterodine vs placebo in subjects with overactive bladder (OAB).

Methods: In a 12-week double-blind trial, subjects were randomized to fesoterodine 4 mg or placebo once daily, taken within 4 hours of bedtime. At week 2, subjects could increase the fesoterodine dose to 8 mg (sham escalation for placebo).

Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence.

Objective: To assess the effects of tolterodine extended release (ER) on patient-reported outcomes (PROs) in sexually active women with overactive bladder (OAB) and urgency urinary incontinence (UUI).

Research Design And Methods: This multicenter, double-blind, placebo controlled trial included 411 women aged > or =18 years reporting OAB symptoms for > or =3 months; > or =8 micturitions per 24 hours (including > or =0.6 UUI episodes and > or =3 OAB micturitions) in 5-day bladder diaries at baseline, and being in a sexually active relationship for > or =6 months.

Combined effects of behavioral intervention and tolterodine in patients dissatisfied with overactive bladder medication.

Purpose: We assessed the effect of tolterodine extended release plus behavioral intervention on treatment satisfaction and bladder diary variables in patients with overactive bladder who had been previously treated and were dissatisfied with tolterodine or other antimuscarinics.

Materials And Methods: This 16-week, multicenter, open label study included eligible patients 18 years old or older who reported overactive bladder symptoms 3 months or greater in duration, 8 or greater micturitions and 2 or greater urgency related micturitions per 24 hours, and 1 or greater urgency urinary incontinence episodes in a 5-day bladder diary at baseline as well as dissatisfaction with prior antimuscarinic medication. Patients received tolterodine extended release plus self-administered behavioral intervention, consisting of an educational pamphlet with verbal reinforcement, for 8 weeks.

Continued symptom improvement in sexually active women with overactive bladder and urgency urinary incontinence treated with tolterodine ER for 6 months.

Improvements in overactive bladder (OAB) symptoms and health-related quality of life (HRQL) were assessed during a 24-week study of tolterodine extended release (TOL ER) in sexually active women with OAB and urgency urinary incontinence (UUI). A 12-week, double-blind, randomized, placebo-controlled trial was followed by a 12-week open-label phase. Sexually active women reported symptoms for >or=3 months.

Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers.

Background: Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder (OAB).

Objective: To evaluate the efficacy of tolterodine extended release (ER) in men on alpha-blocker therapy.

Design, Setting, And Participants: This double-blind trial included men aged > or = 40 yr with frequency, urgency, and at least moderate problems reported on the Patient Perception of Bladder Condition (PPBC), despite being on a stable dose of alpha-blocker for > or = 1 mo.

Efficacy of tolterodine on overactive bladder symptoms and sexual and emotional quality of life in sexually active women.

We evaluated overactive bladder (OAB) symptoms and sexual and emotional health in sexually active women with OAB/urgency urinary incontinence (UUI) treated with tolterodine extended release (ER). Sexually active women with OAB symptoms were randomized to placebo or tolterodine ER. Five-day bladder diaries, Sexual Quality of Life Questionnaire-Female (SQOL-F), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), and Hospital Anxiety and Depression Scale (HAD) were completed at baseline and week 12.

Quality of erections in men treated with flexible-dose sildenafil for erectile dysfunction: multicenter trial with a double-blind, randomized, placebo-controlled phase and an open-label phase.

Introduction: Erectile dysfunction (ED) impacts erection hardness and compromises quality of life.

Aim: Assess erection hardness and its correlation with sexual function, emotional well-being, and satisfaction (erection quality, intercourse, sex life, sexual relationship, and treatment).

Methods: Men with ED were randomized to double-blind, flexible-dose sildenafil (25, 50, or 100 mg) or placebo (6 weeks) with open-label extension (6 weeks).

A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia: the respond trial.

Guidelines stress the importance of the simultaneous management of multiple cardiovascular risk factors. This can in part be achieved by coadministration of lipid-lowering and antihypertensive treatments. Potential pharmacodynamic interaction between drugs should be investigated as part of developing single-pill combinations.

Single-pill therapy in the treatment of concomitant hypertension and dyslipidemia (the amlodipine/atorvastatin gemini study).

The Gemini Study was a 14-week, open-label, non-comparative, office-based, multicenter trial to evaluate single-pill therapy in the treatment of concomitant hypertension and dyslipidemia. In addition to recommending lifestyle modifications, eight dosage strengths of amlodipine/atorvastatin single pill (5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, and 10/80 mg) were electively titrated to improve blood pressure and lipid control. A total of 1220 patients with uncontrolled hypertension at baseline received study medication.