A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

NCT00928070 | Completed Phase 4 Results DMC

• 1 other identifier: A0221049
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 125

Brief Summary

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).

Conditions

Overactive Bladder

Keywords

Urgency Urinary Incontinence OAB

Outcome Measures

Primary Outcomes (2)

• Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

  UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

  Baseline

• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12

  UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

  Baseline, Week 12

Secondary Outcomes (24)

• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4

  Baseline, Week 4

• Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12

  Baseline, Week 4, 12

• Mean Number of Micturitions Per 24 Hours

  Baseline

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12

  Baseline, Week 4, 12

• Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12

  Baseline, Week 4, 12

Study Arms (2)

Fesoterodine

EXPERIMENTAL

Drug: Fesoterodine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fesoterodine DRUG

Fesoterodine 4 mg and 8 mg

Fesoterodine

Placebo DRUG

Placebo sham 4 mg and 8 mg

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (125)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35294, United States

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Montgomery, Alabama, 36117, United States

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Green Valley, Arizona, 85614, United States

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Mesa, Arizona, 85206-1734, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85712, United States

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Tuscon, Arizona, 85710, United States

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Little Rock, Arkansas, 72204, United States

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Little Rock, Arkansas, 72223, United States

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Costa Mesa, California, 92626, United States

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Fairfield, California, 94534, United States

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Glendora, California, 91741, United States

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La Mesa, California, 91942, United States

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Long Beach, California, 90806, United States

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Mission Viejo, California, 92691, United States

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Murrieta, California, 92562, United States

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Norwalk, California, 90650, United States

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Paramount, California, 90723, United States

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Rancho Santa Margarita, California, 92688, United States

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San Bernardino, California, 92404, United States

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San Diego, California, 92108, United States

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Santa Ana, California, 92705, United States

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Temecula, California, 92591, United States

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Vacaville, California, 95688, United States

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Aurora, Colorado, 80012, United States

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Colorado Springs, Colorado, 80907, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80211, United States

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Denver, Colorado, 80220, United States

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Englewood, Colorado, 80110, United States

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Englewood, Colorado, 80113, United States

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Longmont, Colorado, 80501, United States

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Parker, Colorado, 80134, United States

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Groton, Connecticut, 06340, United States

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Milford, Connecticut, 06460, United States

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New London, Connecticut, 06320, United States

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Bonita Springs, Florida, 34134, United States

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Boynton Beach, Florida, 33472, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33756, United States

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Daytona Beach, Florida, 32114, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33316, United States

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Lake Worth, Florida, 33461, United States

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Melbourne, Florida, 32901, United States

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Naples, Florida, 34102, United States

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New Port Richey, Florida, 34652, United States

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New Port Richey, Florida, 34655, United States

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Ocala, Florida, 34471, United States

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Plant City, Florida, 33563, United States

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Sarasota, Florida, 34237, United States

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St. Petersburg, Florida, 33710, United States

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Trinity, Florida, 34655, United States

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Wellington, Florida, 33449, United States

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Winter Haven, Florida, 33880, United States

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Atlanta, Georgia, 30067, United States

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Macon, Georgia, 31217, United States

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Springfield, Illinois, 62702, United States

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Springfield, Illinois, 62703, United States

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Newburgh, Indiana, 47630, United States

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Arkansas City, Kansas, 67005, United States

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Kansas City, Kansas, 66160-7390, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40503, United States

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Lexington, Kentucky, 40504, United States

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Shreveport, Louisiana, 71106, United States

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Baltimore, Maryland, 21211, United States

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Glen Burnie, Maryland, 21061, United States

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Towson, Maryland, 21204, United States

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Springfield, Massachusetts, 01103, United States

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Grand Rapids, Michigan, 49503, United States

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Kalamazoo, Michigan, 49009, United States

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Edina, Minnesota, 55435, United States

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Picayune, Mississippi, 39466, United States

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Southaven, Mississippi, 38671, United States

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St Louis, Missouri, 63117, United States

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Lincoln, Nebraska, 68516, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89119, United States

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Moorestown, New Jersey, 08057, United States

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Sewell, New Jersey, 08080, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11215, United States

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Staten Island, New York, 10304, United States

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Williamsville, New York, 14221, United States

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Cary, North Carolina, 27511, United States

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Cary, North Carolina, 27518, United States

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Raleigh, North Carolina, 27612, United States

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Willoughby Hills, Ohio, 44094, United States

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Bethany, Oklahoma, 73008, United States

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Norman, Oklahoma, 73069, United States

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Oklahoma City, Oklahoma, 73109, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97205, United States

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Altoona, Pennsylvania, 16602, United States

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Erie, Pennsylvania, 16507, United States

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Pittsburgh, Pennsylvania, 15243, United States

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East Providence, Rhode Island, 02914, United States

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East Providence, Rhode Island, 02915, United States

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Charleston, South Carolina, 29425, United States

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Columbia, South Carolina, 29201, United States

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Myrtle Beach, South Carolina, 29572, United States

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37404, United States

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Jackson, Tennessee, 38305, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78745, United States

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Austin, Texas, 78757, United States

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Corpus Christi, Texas, 78414, United States

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Houston, Texas, 77062, United States

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Houston, Texas, 77074, United States

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Leander, Texas, 78641, United States

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Longview, Texas, 75601, United States

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Longview, Texas, 75605, United States

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San Antonio, Texas, 78216, United States

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San Antonio, Texas, 78229, United States

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Temple, Texas, 76508, United States

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Murray, Utah, 84107, United States

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Salt Lake City, Utah, 84103, United States

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West Jordan, Utah, 84088, United States

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Richmond, Virginia, 23229, United States

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Burien, Washington, 98166, United States

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Spokane, Washington, 99216, United States

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Related Publications (2)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

• Dubeau CE, Kraus SR, Griebling TL, Newman DK, Wyman JF, Johnson TM 2nd, Ouslander JG, Sun F, Gong J, Bavendam T. Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial. J Urol. 2014 Feb;191(2):395-404. doi: 10.1016/j.juro.2013.08.027. Epub 2013 Aug 21.

  PMID: 23973522 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 17, 2013
• Results First Posted: January 17, 2013

Record last verified: 2012-12

Locations

US (125)