A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

NCT00425100 | Completed Phase 3 Results

• 1 other identifier: A0221007
• Study Type: interventional
• Target: 516
• Locations: 9 countries
• Sites: 60

Brief Summary

To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (4)

• Mean Number of Micturition Episodes Per 24 Hours

  The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.

  Baseline and Week 12

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

  The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.

  Baseline and Week 12

• Mean Number of Urgency Episodes Per 24 Hours

  The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.

  Baseline and Week 12

• Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment

  Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.

  Week 12

Secondary Outcomes (16)

• Nocturnal Micturitions Per 24 Hours

  Baseline and Week 12

• Severe Urgency Episodes Per 24 Hours

  Baseline and Week 12

• Mean Rating on the Urinary Sensation Scale

  Baseline and Week 12

• Patient Perception of Bladder Condition (PPBC) Score

  Baseline and Week 12

• Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)

  Baseline and Week 12

Study Arms (1)

Open Label-fesoterodine

EXPERIMENTAL

Single treatment study arm.

Drug: fesoterodine fumarate

Interventions

fesoterodine fumarate DRUG

12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.

Open Label-fesoterodine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
• OAB patients dissatisfied with their prior therapy with tolterodine

You may not qualify if:

• Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
• Patients with significant hepatic and renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (60)

Pfizer Investigational Site

Homewood, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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La Mesa, California, 91942, United States

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Orangevale, California, 95662, United States

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Aurora, Colorado, 80012, United States

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West Palm Beach, Florida, 33407, United States

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Aurora, Illinois, 60504, United States

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Pratt, Kansas, 67124, United States

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Shreveport, Louisiana, 71106, United States

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Milford, Massachusetts, 01757, United States

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Omaha, Nebraska, 68114, United States

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Woodlane, New Jersey, 08060, United States

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Kingston, New York, 12401, United States

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New York, New York, 10016, United States

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Poughkeepsie, New York, 12601, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45212, United States

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Bethany, Oklahoma, 73008, United States

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Eugene, Oregon, 97401, United States

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Sellersville, Pennsylvania, 18960, United States

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Houston, Texas, 77024, United States

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Salt Lake City, Utah, 84107, United States

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Salt Lake City, Utah, 84124, United States

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Milwaukee, Wisconsin, 53209, United States

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Brussels, B-1200, Belgium

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Edegem, B-2650, Belgium

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Ghent, B-9000, Belgium

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Jette, B-1090, Belgium

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Turnhout, B-2300, Belgium

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Alajuela Centro, Alajuela Province, Costa Rica

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San José, Costa Rica

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Brno-Bohunice, 625 00, Czechia

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Hradec Králové, 500 05, Czechia

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Prague, 128 08, Czechia

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Prague, 152 00, Czechia

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Alzey, 55232, Germany

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Berlin, 13347, Germany

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Duisburg, 47179, Germany

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Frankfurt, 65929, Germany

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Marburg, 35039, Germany

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Muelheim A.d. Ruhr, 45468, Germany

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München, 81925, Germany

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Lodz, 93-316, Poland

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Mysłowice, 41-400, Poland

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Bratislava, 833 05, Slovakia

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Malacky, 901 01, Slovakia

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Piešťany, 921 01, Slovakia

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Prešov, 080 01, Slovakia

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Skalica, 909 82, Slovakia

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Bucheon-si, Gyunggi-do, 420-767, South Korea

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Busan, 602-739, South Korea

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Daejeon, 301-721, South Korea

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Jeonnam, 519-809, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Chernivtsi, 58002, Ukraine

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Dnipropetrovsk, 49005, Ukraine

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Kharkiv, 61037, Ukraine

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Odesa, 65000, Ukraine

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Pfizer Investigational Site

Zaporizhzhia, 69000, Ukraine

Location

Related Publications (1)

• Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.

  PMID: 19348029 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.govCallCenter@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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 22, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 5, 2018
• Results First Posted: February 10, 2009

Record last verified: 2018-11

Locations

BE (5); US (24); CO (2); CZ (4); PL (2); KR (6); UA (5); DE (7); SL (5)