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

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Viatris

Status and phase

Completed
Phase 4

Conditions

Urinary Incontinence

Treatments

Drug: Tolterodine ER 4 mg QD
Drug: Tamsulosin 0.4 mg QD

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147654
A6121120

Details and patient eligibility

About

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).

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

95

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Data sourced from clinicaltrials.gov

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