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

Prostate Adenocarcinoma Clinical Trial

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 )

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661166
• Other study ID #: UPCC 15810
• Status: Completed
• Phase: Phase 4
• Start date: January 2012
• Est. completion date: April 15, 2013

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 15, 2013
• Est. primary completion date: April 15, 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine
4 mg
• Placebo oral tablet
Placebo

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		3 months