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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01661166

Collaborator

(none)

Enrollment

Location

Arms

15.4

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Adenocarcinoma	Drug: Fesoterodine Drug: Placebo oral tablet	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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 )

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Apr 15, 2013

Actual Study Completion Date :

Apr 15, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine 4mg Fesoterodine 4mg, Oral once daily for three months	Drug: Fesoterodine 4 mg
Placebo Comparator: Placebo Placebo Oral once daily for three months	Drug: Placebo oral tablet Placebo

Arm

Intervention/Treatment

Experimental: Fesoterodine 4mg

Fesoterodine 4mg, Oral once daily for three months

Drug: Fesoterodine

4 mg

Placebo Comparator: Placebo

Placebo Oral once daily for three months

Drug: Placebo oral tablet

Placebo

Outcome Measures

Primary Outcome Measures

Number of Adverse Events [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.