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

April 24, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: David Lee, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

April 15, 2013

Study Completion (ACTUAL)

April 15, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (ESTIMATE)

August 9, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 15810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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