A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

NCT00645281 | Completed Phase 4

• 1 other identifier: A6121001
• Study Type: interventional
• Target: 896
• Locations: 1 country
• Sites: 96

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

Conditions

Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry

  12 weeks

Secondary Outcomes (8)

• OAB Bother Rating Scale at baseline

  baseline

• Change from baseline to Week 4 and 12 in micturition bladder diary variables

  12 weeks

• Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition

  12 weeks

• Change from baseline to Week 4 and 12 in AUA Symptom Index

  12 weeks

• Change from baseline to Week 4 and 12 in OAB questionnaire

  12 weeks

Study Arms (1)

tolterodine ER group

EXPERIMENTAL

Drug: tolterodine extended release

Interventions

tolterodine extended release DRUG

Tolterodine ER capsule 4 mg daily for 12 weeks

tolterodine ER group

Eligibility Criteria

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

You may qualify if:

• self-reported symptoms of OAB for ≥ 3 months prior to screening
• OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
• urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
• patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

You may not qualify if:

• any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
• any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
• stress incontinence, functional, or overflow incontinence as determined by the investigator
• symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI \>3 times in the 12 months prior to participation in this clinical trial
• clinically significant urinary tract obstruction
• history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
• clinically significant interstitial cystitis or significant bladder pain syndrome

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (96)

Pfizer Investigational Site

Birmingham, Alabama, 35211, United States

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Birmingham, Alabama, 35213, United States

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Birmingham, Alabama, 35234, United States

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Huntsville, Alabama, 35801, United States

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Montgomery, Alabama, 36117, United States

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Phoenix, Arizona, 85051, United States

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Sun Lakes, Arizona, 85248, United States

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Bentonville, Arkansas, 72712, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72204, United States

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Buena Park, California, 90620, United States

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Foothill Ranch, California, 92610, United States

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Fresno, California, 93710, United States

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West Covina, California, 91790, United States

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Colorado Springs, Colorado, 80904, United States

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Lakewood, Colorado, 80228, United States

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Chipley, Florida, 32428, United States

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Davie, Florida, 33328, United States

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Hallandale, Florida, 33009, United States

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Miami, Florida, 33145, United States

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Miami Beach, Florida, 33140, United States

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Murdock, Florida, 33948, United States

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Ocala, Florida, 34471, United States

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Pembroke Pines, Florida, 33024, United States

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Saint Cloud, Florida, 34769, United States

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Tampa, Florida, 33607, United States

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Atlanta, Georgia, 30308, United States

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Barnesville, Georgia, 30204, United States

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Blue Ridge, Georgia, 30513, United States

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Decatur, Georgia, 30034, United States

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Chicago, Illinois, 60610, United States

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Naperville, Illinois, 60564, United States

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Orland Park, Illinois, 60462, United States

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Newton, Kansas, 67114, United States

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Shawnee Mission, Kansas, 66203, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Marrero, Louisiana, 70072, United States

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Laurel, Maryland, 20707, United States

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Oxon Hill, Maryland, 20745, United States

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Jackson, Michigan, United States

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Portage, Michigan, 49002, United States

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St Louis, Missouri, 63117, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89146, United States

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Blackwood, New Jersey, 08012, United States

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Mount Laurel, New Jersey, 08054, United States

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Binghamton, New York, 13901, United States

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Endicott, New York, 13760, United States

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Endwell, New York, 13760, United States

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Kingston, New York, 12401, United States

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Beaufort, North Carolina, 28516, United States

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Charlotte, North Carolina, 28207, United States

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Charlotte, North Carolina, 28262, United States

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Durham, North Carolina, 27703, United States

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Morehead City, North Carolina, 28557, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43213, United States

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Kettering, Ohio, 45429, United States

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Central Point, Oregon, 97502, United States

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Medford, Oregon, 97504, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Bensalem, Pennsylvania, 19020, United States

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Connellsville, Pennsylvania, 15425, United States

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Philadelphia, Pennsylvania, 19103, United States

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Philadelphia, Pennsylvania, 19147, United States

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Philadelphia, Pennsylvania, 19148, United States

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Sellersville, Pennsylvania, 18960, United States

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Stoneboro, Pennsylvania, 16153, United States

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Warwick, Rhode Island, 02886, United States

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Greer, South Carolina, 29651, United States

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Simpsonville, South Carolina, 29681, United States

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Cordova, Tennessee, 38018, United States

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Huntingdon, Tennessee, 38344, United States

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Lexington, Tennessee, 38351, United States

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Savannah, Tennessee, 38372, United States

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Selmer, Tennessee, 38375, United States

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Waynesboro, Tennessee, 38485, United States

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Austin, Texas, 78705, United States

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Bryan, Texas, 77802, United States

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Colleyville, Texas, 76034, United States

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Friendswood, Texas, 77546, United States

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Houston, Texas, 77030, United States

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Plano, Texas, 75093-5841, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78217, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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West Jordan, Utah, 84084, United States

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West Valley City, Utah, 84120, United States

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Spokane, Washington, 99207, United States

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Spokane, Washington, 99208, United States

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Milwaukee, Wisconsin, 53221, United States

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New Berlin, Wisconsin, 53151, United States

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Oregon, Wisconsin, 53575, United States

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Wauwatosa, Wisconsin, 53226, United States

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Related Links

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

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 27, 2008
• Study Start: March 1, 2004
• Study Completion: January 1, 2005
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (96)