Overview

A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy

Status:
Completed
Trial end date:
2013-04-15
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Treatments:
Fesoterodine
Criteria
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 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.