Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-08-31

Brief Summary

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To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tolterodine ER

Group Type EXPERIMENTAL

Tolterodine ER

Intervention Type DRUG

One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.

Interventions

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Tolterodine ER

One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.

Intervention Type DRUG

Placebo

A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and 21 years or older
* Overactive bladder symptoms (subject-reported) for at least 3 months
* Be resident in the United States of America and have access and be able to use a computer with internet access throughout the duration of the study

Exclusion Criteria

* Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.
* History of cystitis, continence, urogenitalcancer or radiation
* Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No