Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      1. Objectives

             1. Primary objective: To explore the "Patient-reported Goal Attainment (PGA)" after 12
                weeks of treatment with tolterodine extended-release (ER) 4mg in female overactive
                bladder (OAB) patients.

             2. Secondary objective: To explore the patient-reported treatment goals and the
                efficacy of tolterodine on the patient-reported outcomes (PROs), micturition diary
                parameters, and safety parameters from baseline to 12 weeks of treatment in female
                OAB patients.

        2. Specific aim

           : To compare the efficacy of tolterodine ER 4mg with that of placebo, on PROs in terms
           of PGA after 12 weeks of treatment in female OAB patients.

        3. Experimental/research design

             1. 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective
                study in Korean women with symptoms of OAB

             2. Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo
                (randomized in the ratio of 1:1) for 12 weeks.

             3. Time schedule Start date: 01/Jan/2009 Finish date: 01/Sep/2009 Duration of washout:
                7 days Duration of run-in: 7 days Duration of enrollment period: 5 months Duration
                of treatment period: 12 weeks Completion of analysis: 6 weeks
    

Intervention name(s): Tolterodine extended-release (ER) 4mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tolterodine extended-release (ER) 4mg once daily for 12 weeks; Identical Placebo once daily
Other intervention name(s): Detrusitol ER 4mg
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Overactive bladder; Antimuscarinics; Patient-reported goal achievement