Study on Clinical Effectiveness and Safety of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) at Different Dosage in Korean Patients
The objective of this study is to investigate the effectiveness of oxybutynin chloride OROS on patient-reported outcomes after 12 weeks of treatment through the increasing of dosage levels for overactive bladder (OAB) patients
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effectiveness of Oxybutynin Chloride OROS in Patient-reported Outcomes With Dose Escalation in Korean Overactive Bladder Patients|
- Evaluating the 'Achievement of the Treatment Goal' after 12 weeks of treatment with 10-30mgs doses, according to the reactions of OAB patents.
- Evaluating patient-recorded outcomes for items, including treatment satisfaction, variables of micturition chart, (frequency of urgent urination, reduction of seriousness of symptoms, reduction of incontinence episodes, and urination events)
|Study Start Date:||September 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Traditionally, the success of treatment for OAB was measured in terms of patient-perceived levels of cure, improvements of symptoms, number of urination episodes over 24 hours, reduction of incontinence episodes, and side effects. Urodynamic measures on bladder function include urination amount at the time of initial contraction, maximum capacity of the bladder, and the amount of residual urine. Traditional symptomatic and urodynamic measures of successful treatment may be meaningful for doctors, but normally these did not deal with what was important for patients. Therefore, it is necessary to assess Patient-Reported Outcomes (PROs) to provide subjective outcomes of measurements on patients' reactions to the treatment. For diseases like overactive bladder, for which symptoms are already well defined, PROs can be the best way to observe treatment. If the treatment actually improves the symptoms and if such improvements positively affect the health-related quality of life of the patients. Overactive bladder can be defined by several different symptoms but not all patients experience all of them. Some may have only one whereas others may have differing combinations of them. Similarly, the severity of the symptoms differ among different patients. Therefore, evaluating symptom-specific PROs for different treatment regimens may provide valuable information for the treatment of OAB. The patient begins treatment with a 10mg dose of oxybutynin chloride OROS daily. The dose will be controlled in 10mg units based on the Optimal Dose Evaluation Criteria. Dosage changes will be conducted over six weeks at two week intervals, until the optimal dose is achieved. Treatment will continue for an additional six weeks with the optimal dose. Initially, patient takes 10mg a day and then, the dose will be adjusted by 10mg two-week interval according to Optimal Dose Evaluation Criteria. Maximum daily dose is 30mg.