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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00645281
Pfizer
Completed
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

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[email protected]

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