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

Abramson Cancer Center at Penn Medicine

Status and phase

Completed

Phase 4

Conditions

Prostate Adenocarcinoma

Treatments

Drug: Fesoterodine

Drug: Placebo oral tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT01661166

UPCC 15810

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

Male

Ages

30 to 90 years old

Volunteers

No Healthy Volunteers

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.