Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

Completed · Phase 4

Conditions studied: Urinary Incontinence

In brief

The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).

Key facts

Study ID

NCT00147654

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

830

Starts

2004-11-01

Expected to finish

2006-05-01

Last updated by the study team

2021-01-27

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male 40 years of age
• Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
• Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

You may not qualify if…

• Post-void residual urine volume (PVR) of > 200 ml as measured by an ultrasound
• Maximum urinary flow rate (Qmax) of < 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
• Prescribed and administered an antimuscarinic or antispasmodic within 1 month
• Prescribed and administered an a-1-adrenergic antagonist within 2 weeks

Where it is running

• Pfizer Investigational Site — Homewood, Alabama, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Culver City, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — La Mesa, California, United States
• Pfizer Investigational Site — Long Beach, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Murrieta, California, United States
• Pfizer Investigational Site — Poway, California, United States
• Pfizer Investigational Site — San Bernardino, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Boulder, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — New Britain, Connecticut, United States
• Pfizer Investigational Site — Waterbury, Connecticut, United States
• Pfizer Investigational Site — Melbourne, Florida, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — Tallahassee, Florida, United States
• Pfizer Investigational Site — Wellington, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Columbus, Georgia, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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