A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
Completed · Phase 4 · Has a placebo group
Conditions studied: Prostate Adenocarcinoma
In brief
The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients. Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.
Key facts
- Study ID
- NCT01661166
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 3
- Starts
- 2012-01-01
- Expected to finish
- 2013-04-15
- Last updated by the study team
- 2020-04-28
Who can join
Age: 30 and older, up to 90. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men aged 30 to 90 years old with prostate adenocarcinoma who have already made their treatment selection of RARP, and only men with an AUA symptom score greater than 7 will be included. All subjects must be able to read and comprehend fully the informed consent.
You may not qualify if…
- Men with prostate neoplasms other than adenocarcinoma
- 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.
Where it is running
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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