A 12 week, multicentre, open label study to evaluate the efficacy, tolerability and safety of a Fesoterodine flexible dose regimen in patients with overactive bladder

Pfizer Limited0 sites326 target enrollmentJanuary 20, 2009

ConditionsTreatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder

DrugsToviaz

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.
Sponsor: Pfizer Limited
Enrollment: 326
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 20, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Pfizer Limited

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
•1\. Male or female outpatients \=18 years old.
•2\. Overactive bladder symptoms (subject\-reported) for \=3 months prior to Screening/Visit 1\.
•3\. Mean urinary frequency of ?\=8 micturitions per 24 hours as verified by the screening bladder diary prior to Baseline/Visit 2\.
•4\. Mean number of Urgency episodes \=3 per 24 hours as verified by the screening bladder diary prior to Baseline/Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating \=3\).
•5\. Rate their bladder as causing (Some) Moderate Problems”, Severe Problems” or Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) Questionnaire at Visit 2\.
•6\. Able and willing to complete the micturition bladder diaries and all trial related
•questionnaires, comply with scheduled clinic visits and clinical trial procedures.
•7\. Capability of understanding and having signed the informed consent form after full
•discussion of the treatment and its risk and benefits.

Exclusion Criteria

•1\.Any condition that would contraindicate the usage of fesoterodine including, but not limited to: hypersensitivity to the active substance (fesoterodine fumarate) or any of the excipients, or to peanut or soya; urinary retention; gastric retention; uncontrolled narrow angle glaucoma; myasthenia gravis; moderate or severe hepatic impairment (Child Pugh C); severe renal impairment; severe ulcerative colitis, and toxic megacolon.
•2\.Neurologic conditions, such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease.
•3\.Stage 3 or greater pelvic organ prolapse, defined as tissue protruding to or beyond the introitus in lithotomy position at rest (without increase in intra abdominal pressure).
•4\.History of lower urinary tract surgery (eg, incontinence surgery or surgery to reduce prostate size; or transurethral resection of the prostate (TURP) or bladder (TURBT) with the exception of any minor surgery (eg, cystoscopic procedures)) within the past 6 months.
•5\.A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated haematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumour, radiation cystitis, genito\-urinary tuberculosis, bladder calculi, or detrusor\-sphincter dyssynergia.
•6\.Active bladder stones. Subjects with a previous history of bladder stones may be included.
•7\.Previous history of acute urinary retention requiring catheterization, clinically relevant bladder outlet obstruction or severe voiding difficulties in the judgment of the investigator, prior to Visit 2\.
•8\.Use of an indwelling catheter or an intermittent self\-catheterisation programme.
•9\.Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
•10\.Urinary tract infection (UTI) as shown by the results of the urinalysis at Screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI ?3 times in the last year.