A Randomized, Double Blind, Placebo Controlled Detrol LA Add-On To Alpha-Blocker Study in men with persistent Overactive Bladder symptoms of urinary frequency and urgency with/without urgency incontinence after previous monotherapy with alpha blocker. - NA

Pfizer Ltd0 sites608 target enrollmentDecember 8, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Pfizer Ltd
Enrollment: 608
Status: Active, Not Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 8, 2005

End Date

May 14, 2007

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Pfizer Ltd

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
•1\.Men aged 40 years and above (with no upper limit of age)
•2\.On a stable dose of an alpha\-blocker for at least 1 month
•3\.Persistent symptoms of OAB as verified by the screening 5 day micturition diary, defined by:
•a.Mean urinary frequency \=8 times/24 hours
•b.Mean number of urgency episodes, with/without urgency incontinence, \=1 episode/24 hours (with a Urinary Sensation Scale rating of \=3 in the micturition diary)
•4\.A rating of the bladder condition at Baseline (visit 2\) prior to randomization as Some Moderate Problems”, Severe Problems”, or Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire
•5\.The ability and willingness to correctly complete the micturition diary and various questionnaires, comply with scheduled visits and comply with trial procedures
•6\.The capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits
•Are the trial subjects under 18? no

Exclusion Criteria

•Subjects presenting with any of the following will not be included in the trial:
•1\.Previous history of acute urinary retention requiring catheterization
•2\.A post void residual urinary volume greater than 200mls at Screening (visit 1\)
•3\.Poor detrusor function or clinically relevant bladder outlet obstruction based on investigator’s judgment as shown in a flow rate and residual volume measurement at Screening (visit 1\)
•4\.A 5\-alpha reductase inhibitor if started less than 6 months prior to Screening (visit 1\)
•5\.Urinary tract infection (UTI), including bacterial prostatitis, confirmed by a positive urine test or recurrent UTI defined as being treated for \>3 episodes of symptomatic UTI in the past 12 months
•6\.A known history of bladder outlet obstruction due to: vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
•7\.A known history of uninvestigated haematuria, interstitial cystitis, genitor\-urinary tuberculosis, bladder calculi or detrusor\-sphincter dyssynergia8\.Previous history of prostatic surgery/intervention (including minimally invasive treatments), or other major urethral and/or bladder surgery or if subjects have any AEs requiring prostate surgery/intervention to relieve bladder outlet flow obstruction
•9\.History or suspicion of prostate cancer including a serum PSA (prostate specific antigen) concentration of greater than 10 ng/ml on repeat testing
•10\.History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.