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

NCT ID: NCT01661166

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-15

Brief Summary

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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

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Conditions

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Prostate Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fesoterodine 4mg

Fesoterodine 4mg, Oral once daily for three months

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

4 mg

Placebo

Placebo Oral once daily for three months

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo

Interventions

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Fesoterodine

4 mg

Intervention Type DRUG

Placebo oral tablet

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 15810

Identifier Type: -

Identifier Source: org_study_id

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