Back to resultsA Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
Primary Purpose
Prostate Adenocarcinoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fesoterodine
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Male adult subjects, aged 30-90 years, RARP, American Urological Association symptom score greater than 7 will be included
Eligibility 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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fesoterodine 4mg
Placebo
Arm Description
Fesoterodine 4mg, Oral once daily for three months
Placebo Oral once daily for three months
Outcomes
Primary Outcome Measures
Number of Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01661166
First Posted
July 18, 2012
Last Updated
April 24, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01661166
Brief Title
A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 15, 2013 (Actual)
Study Completion Date
April 15, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Male adult subjects, aged 30-90 years, RARP, American Urological Association symptom score greater than 7 will be included
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fesoterodine 4mg
Arm Type
Experimental
Arm Description
Fesoterodine 4mg, Oral once daily for three months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Oral once daily for three months
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Intervention Description
4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Lee, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
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