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

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 )

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01661166

Enrollment

Registered

2012-08-09

Start date

2012-01-31

Completion date

2013-04-15

Last updated

2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma

Keywords

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

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.

Interventions

DRUGFesoterodine

4 mg

DRUGPlacebo oral tablet

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

30 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of Adverse Events	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026