A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
NCT ID: NCT01661166
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
3 participants
INTERVENTIONAL
2012-01-31
2013-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fesoterodine 4mg
Fesoterodine 4mg, Oral once daily for three months
Fesoterodine
4 mg
Placebo
Placebo Oral once daily for three months
Placebo oral tablet
Placebo
Interventions
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Fesoterodine
4 mg
Placebo oral tablet
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects receiving other treatments for prostate cancer will be excluded.
* Any subject with a preexisting bladder disease will be excluded.
* Subjects with acute urinary retention and/or deceased gastrointestinal motility.
* Subjects with glaucoma.
* Subjects with hepatic or renal impairment.
* Subjects taking CYP3A4 Inhibitors (e.g.ketoconazole, itraconazole, clarithromycin).
* Subjects with myasthenia gravis
* Subjects who are unwilling or unable to complete the subject questionnaires
* Subjects, who in the opinion of the investigator, would be non-compliant with the majority of the visits scheduled or study procedures.
30 Years
90 Years
MALE
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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David Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 15810
Identifier Type: -
Identifier Source: org_study_id
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