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

Phase 4

Completed

• Conditions: Prostate Adenocarcinoma
• Interventions: Drug: Fesoterodine; Drug: Placebo oral tablet

• Registration Number: NCT01661166
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Primary Completion: 2013-04-15
• Study Completion: 2013-04-15
• Status Verified: 2020-04
• Disposition First Submitted: 2020-04-06
• Disposition First Submitted QC: 2020-04-24
• Last Update Submitted: 2020-04-24
• Disposition First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fesoterodine 4mg	Fesoterodine	Fesoterodine 4mg, Oral once daily for three months
Placebo	Placebo oral tablet	Placebo Oral once daily for three months

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	3 months

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States