Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder
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.
Drug: Tolterodine extended-release (ER) 4mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ)|
- Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4 [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks) ] [ Designated as safety issue: No ]
- Assessment of patient-reported treatment goal [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks) ] [ Designated as safety issue: Yes ]
- Patient-reported outcomes [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), ] [ Designated as safety issue: Yes ]
- Micturition diary efficacy parameters [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), ] [ Designated as safety issue: Yes ]
- Safety parameters [ Time Frame: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks), ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Tolterodine ER
Tolterodine ER 4mg once daily
Drug: Tolterodine extended-release (ER) 4mg
Tolterodine extended-release (ER) 4mg once daily for 12 weeks
Other Name: Detrusitol ER 4mg
Placebo Comparator: Placebo
Placebo once daily
Identical Placebo once daily
Other Name: Placebo
- 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.
- 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.
: 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.
- 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB
- Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836381
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Kyu-Sung Lee, Ph.D||Samsung Medical Center|