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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 )


Phase 4
30 Years
90 Years
Open (Enrolling)
Male
Prostate Adenocarcinoma

Thank you

Trial Information

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 )


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 gastointestinal motility.

- Subjects with glaucoma.

- Subjects with hepatic or renal impairment.

- Subjects taking CYP3A4 Inhibitors (e.g.ketoconazole, intraconazole, 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Safety Issue:

Yes

Principal Investigator

David Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 15810

NCT ID:

NCT01661166

Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Prostate Adenocarcinoma
  • Male adult subjects
  • aged 30-90 years
  • RARP
  • AUA symptom score greater than 7 will be included
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms
  • Urinary Bladder, Overactive

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283