Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01661166
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 2012
Actual Primary Completion Date : April 15, 2013
Actual Study Completion Date : April 15, 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661166


Locations
Layout table for location information
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: David Lee, MD Abramson Cancer Center of the University of Pennsylvania
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01661166    
Other Study ID Numbers: UPCC 15810
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Male adult subjects
aged 30-90 years
RARP
American Urological Association symptom score greater than 7 will be included
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents