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Clinical Trials/NCT01661166
NCT01661166CompletedPhase 4

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 )

Abramson Cancer Center at Penn Medicine1 site in 1 country3 target enrollmentStarted: January 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
3
Locations
1
Primary Endpoint
Number of Adverse Events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
30 Years to 90 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Fesoterodine 4mg

Experimental

Fesoterodine 4mg, Oral once daily for three months

Intervention: Fesoterodine (Drug)

Placebo

Placebo Comparator

Placebo Oral once daily for three months

Intervention: Placebo oral tablet (Drug)

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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