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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Tamsulosin; Tolterodine Tartrate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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