A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00928070

Purpose

This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).

Condition	Intervention	Phase
Overactive Bladder	Drug: Fesoterodine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at Week 12 relative to baseline (defined as those micturitions with Urinary Sensation Scale rating of 5 in the diary) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bladder Diary [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
Protective Undergarment Usage [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
PROs (PPBC, OAB-q, OAB-S) [ Time Frame: 4 and/or 12 weeks ] [ Designated as safety issue: No ]
Cognition Assessment (MMSE) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
PVR [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: Yes ]
Safety Evaluations [ Time Frame: 4,8, and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	566
Study Start Date:	September 2009
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fesoterodine	Drug: Fesoterodine Fesoterodine 4 mg and 8 mg
Placebo Comparator: Placebo	Drug: Placebo Placebo sham 4 mg and 8 mg

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female subjects 65 years of age or older
OAB symptoms for at least 3 months
score 3 or greater on Vulnerable Elderly Survey (VES-13)
adequate mobility for independent toileting
mean number of at least 2 UUI episodes per 24 hours
mean urinary frequency of 8 or more micturitions per 24 hours
able to independently complete the bladder diaries

Exclusion Criteria:

PVR urinary volume greater than 200 ml
MMSE score less than 20
greater than 15 UUI episodes per 24 hours
creatinine clearance less than 30 ml/min
an average resting heart rate of greater than or equal to 90 beats per minute

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928070

Show 125 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00928070 History of Changes
Other Study ID Numbers:	A0221049
Study First Received:	June 24, 2009
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Urgency Urinary Incontinence OAB

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012