A Study of the Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Laparoscopic Prostatectomy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Overactive Bladder |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 30 - 90 |
| Updated: | 9/29/2018 |
| Start Date: | January 2012 |
A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Laparoscopic Prostatectomy )
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.
(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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 gastointestinal motility.
- Subjects with glaucoma.
- Subjects with hepatic or renal impairment.
- Subjects taking CYP3A4 Inhibitors (e.g.ketoconazole, intraconazole, 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.
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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