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.