Tolterodine ER reduced increased bladder wall thickness in women with overactive bladder. A randomized, placebo-controlled, double-blind, parallel group study.

Aims: We evaluated the effect of Tolterodine extended release (TER) versus placebo on bladder wall thickness (BWT) using transvaginal ultrasound in women with overactive bladder (OAB).

Materials And Methods: We recruited 79 women with symptoms of OAB with a mean age of 47 years who had a BWT of at least 5 mm and a post-micturition volume of less than 50 mL at screening. Subjects received TER 4 mg or placebo once daily for the first 12 weeks of the study.

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.

Long-term safety, tolerability and efficacy of fesoterodine in subjects with overactive bladder symptoms stratified by age: pooled analysis of two open-label extension studies.

Background: Previous work has demonstrated the efficacy and safety of fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term fesoterodine treatment in different age groups has not been assessed.

Objective: The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with fesoterodine 8 mg in subjects with OAB syndrome.

Add-on fesoterodine for residual storage symptoms suggestive of overactive bladder in men receiving α-blocker treatment for lower urinary tract symptoms.

Unlabelled: Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Male lower urinary tract symptoms are often attributed to bladder outlet obstruction secondary to benign prostatic hyperplasia and treated with drugs targeting the prostate. However, many men with storage lower urinary tract symptoms may not respond adequately to these agents. Antimuscarinics, with or without an α-blocker, may be effective for the treatment of the storage symptoms of overactive bladder in some men.

The psychometric validation of a 1-week recall period for the OAB-q.

Introduction And Hypothesis: As shorter recall periods are sometimes preferable to longer recall periods, the objective of this study was to evaluate the psychometric characteristics and measurement properties of the 1-week recall version of the Overactive Bladder Questionnaire (OAB-q).

Methods: Secondary analyses were performed on data for three 12-week clinical trials of fesoterodine. Patients completed the Patient Perception of Bladder Condition (PPBC), the Patient Perception of Urgency Scale (PPUS), and 3-day bladder diaries in addition to the OAB-q at baseline, 4 and 12 weeks.

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).

Promise of Urinary Nerve Growth Factor for Assessment of Overactive Bladder Syndrome.

Overactive bladder syndrome (OAB) is highly prevalent bladder disorder in men and women. About 10-15% of the population suffers from urgency frequency with or without urgency urinary incontinence. It is estimated that 50-75% of patients with OAB may have urodynamic detrusor overactivity (DO).

Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder.

Objective: To assess the onset of efficacy of fesoterodine 4 mg versus placebo in subjects with overactive bladder (OAB) symptoms.

Research Design And Methods: Subjects who reported OAB symptoms for ≥ 3 months and recorded ≥ 8 micturitions and ≥ 1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4 mg, tolterodine extended release (ER) 4 mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial.

Superior efficacy of fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head, placebo-controlled trial.

Objective: • To show the superior efficacy of fesoterodine over tolterodine extended release (ER) in a placebo-controlled overactive bladder (OAB) trial with predefined treatment comparisons for both diary measures and patient-reported outcomes.

Materials And Methods: • In this 12-week, double-blind, double-dummy trial, subjects reporting >1 urgency urinary incontinence (UUI) episode and ≥8 micturitions per 24 h at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo. • Subjects completed 3-day bladder diaries, the Patient Perception of Bladder Condition (PPBC) and the Urgency Perception Scale (UPS) at baseline and weeks 1, 4 and 12 and the OAB Questionnaire at baseline and week 12.

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.

Modeling dose-response relationships of the effects of fesoterodine in patients with overactive bladder.

Background: Fesoterodine is an antimuscarinic for the treatment of overactive bladder, a syndrome of urgency, with or without urgency urinary incontinence (UUI), usually with increased daytime frequency and nocturia. Our objective was to develop predictive models to describe the dose response of fesoterodine.

Methods: Data from subjects enrolled in double-blind, placebo-controlled phase II and III trials were used for developing longitudinal dose-response models.

Dynamic progression of overactive bladder and urinary incontinence symptoms: a systematic review.

Context: Overactive bladder (OAB) and urinary incontinence (UI) are worldwide public health problems. Longitudinal epidemiologic studies that assess the natural history of OAB and UI are valuable in making accurate prognoses, determining causes and consequences, and predicting resource utilization.

Objective: Our aim was to assess whether the severity of OAB and UI symptoms progress dynamically over time, with the secondary aim of assessing factors that may be associated with symptom progression and regression.

Efficacy and safety of tolterodine extended-release in men with overactive bladder symptoms treated with an α-blocker: effect of baseline prostate-specific antigen concentration.

Objective: To determine whether the efficacy and safety of a combination of tolterodine extended-release (ER) plus α-blocker treatment varies with high or low levels of serum prostate-specific antigen (PSA) in men who have persistent overactive bladder (OAB) symptoms after any α-blocker monotherapy.

Patients And Methods: Men aged ≥ 40 years were eligible if they reported ≥ 8 micturitions/24 h, including ≥ 1 urgency episode/24 h with or without urgency urinary incontinence (UUI), and at least some moderate bladder-related problems at baseline despite receiving treatment with an α-blocker for ≥ 1 month. Exclusion criteria included a postvoid residual urine volume (PVR) of ≥ 200 mL and history of acute urinary retention requiring catheterization.

Fesoterodine in patients with overactive bladder syndrome: can the severity of baseline urgency urinary incontinence predict dosing requirement?

Objectives: To determine whether baseline urgency urinary incontinence (UUI) episodes predict the need for increased doses of fesoterodine in patients with overactive bladder (OAB), as clinicians would benefit from data that help to predict which patients require higher doses of antimuscarinics to manage UUI episodes.

Patients And Methods: In this pooled analysis of data from two double-blind, placebo-controlled trials, patients were randomized to placebo or fesoterodine 4 or 8 mg for 12 weeks and stratified into tertiles (>0-<2, 2-<4, or > or =4) according to the number of UUI episodes/24 h as recorded in 3-day bladder diaries at baseline. The change in mean UUI episodes/24 h from baseline to end of study was assessed using analysis of covariance.

Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head-to-head placebo-controlled trial.

Objective: To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended-release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB).

Patients And Methods: In this 12-week double-blind, double-dummy, placebo-controlled, randomized clinical trial, eligible patients reported OAB symptoms for > or = 3 months and recorded > or = 8 voids and > or = 1 urgency urinary incontinence (UUI) episode per 24 h in 3-day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo).

Efficacy of fesoterodine over 24 hours in subjects with overactive bladder.

Objective: Fesoterodine is an antimuscarinic agent indicated for the treatment of overactive bladder (OAB) symptoms. The objective of this study was to evaluate the efficacy of fesoterodine versus placebo over selected intervals during a 24-hour period in subjects with OAB.

Research Design And Methods: In a post hoc analysis, data were analyzed from two randomized, double-blind, placebo-controlled 12-week phase III trials in which subjects with a history of OAB symptoms for >or=6 months were treated with morning doses of fesoterodine 4 mg, fesoterodine 8 mg, or placebo.

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).

Efficacy and tolerability of fesoterodine in men with overactive bladder: a pooled analysis of 2 phase III studies.

Objectives: To assess the efficacy, safety, and tolerability of fesoterodine 4 and 8 mg in men with overactive bladder.

Methods: This was a subanalysis of pooled data from 358 men enrolled in 2 double-blind, placebo-controlled phase III trials. Subjects with frequency and urgency or urgency urinary incontinence (UUI) were randomized to fesoterodine 4 mg, fesoterodine 8 mg, or placebo for 12 weeks.

Transabdominal ultrasonography of detrusor wall thickness in women with overactive bladder.

Objective: To determine the clinical usefulness of measuring detrusor wall thickness (DWT) as a noninvasive test in women with overactive bladder (OAB).

Patients, Subjects And Methods: We prospectively enrolled 122 women with dry OAB, wet OAB, and women with no OAB symptoms (control group). A 3-day voiding diary was used to differentiate between wet and dry OAB.

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.

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.

Effects of tolterodine extended release on patient perception of bladder condition and overactive bladder symptoms*.

Objective: To evaluate the efficacy of tolterodine extended release (ER) versus placebo at 1 and 12 weeks using questionnaires and diary measures.

Research Design And Methods: Subjects with overactive bladder (OAB) were randomized to receive tolterodine ER (4 mg) or placebo for 12 weeks. This double-blind study is registered with ClinicalTrials.

Effects of serum PSA on efficacy of tolterodine extended release with or without tamsulosin in men with LUTS, including OAB.

Objectives: To evaluate the efficacy of tolterodine extended release (ER), tamsulosin, and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen (PSA) level.

Methods: We performed a post hoc analysis of data from men >or=40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume <200 mL, maximal urinary flow rate >5 mL/s, International Prostate Symptom Score (IPSS) of >or=12, and quality-of-life score of >or=3. They had been randomized to placebo, tolterodine ER (4 mg), tamsulosin (0.

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.