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Completed

NCT Number: NCT01661166

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

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Key information

Conditions

Prostate Adenocarcinoma

Age range

30 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fesoterodine

Drug

4 mg

Placebo oral tablet

Drug

Placebo

Primary outcomes

  1. Number of Adverse Events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study 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 )

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2012
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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