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Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

NCT00836381 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2013-05-30

No results posted yet for this study

Summary

For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA).

Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit.

This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.

Conditions

Interventions

DRUG

Tolterodine extended-release (ER) 4mg

Tolterodine extended-release (ER) 4mg once daily for 12 weeks

DRUG

Placebo

Identical Placebo once daily

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Kyu-Sung Lee, Ph.D · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00836381 on ClinicalTrials.gov