CompletedPhase 4

A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.

Austria, Belgium794 participantsStarted 2008-06

Plain-language summary

The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female ≥65 years old. * Overactive bladder symptoms for at least 3 months prior to study start. * Eight or more micturitions per 24 hours as confirmed by diary records Exclusion Criteria: * Predominant Stress Urinary Incontinence * Active or recurrent bladder infections * Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.

What they're measuring

Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT00798434

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-09

Results submitted2011-07-11

View on ClinicalTrials.gov More Urinary Bladder, Overactive trials