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

NCT01661166 | Completed Phase 4 DMC

• 1 other identifier: UPCC 15810
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Keywords

Male adult subjects; aged 30-90 years; RARP; American Urological Association symptom score greater than 7 will be included

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  3 months

Study Arms (2)

Fesoterodine 4mg

EXPERIMENTAL

Fesoterodine 4mg, Oral once daily for three months

Drug: Fesoterodine

Placebo

PLACEBO COMPARATOR

Placebo Oral once daily for three months

Drug: Placebo oral tablet

Interventions

Fesoterodine DRUG

4 mg

Fesoterodine 4mg

Placebo oral tablet DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

fesoterodine

Study Officials

• David Lee, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: August 9, 2012
• Study Start: January 1, 2012
• Primary Completion: April 15, 2013
• Study Completion: April 15, 2013
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)