Overactive Bladder
Conditions
Brief summary
A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin
Detailed description
To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin
Interventions
DRUGsolifenacin 5mg, 10mg
solifenacin 5mg, 10mg
Sponsors
Samsung Medical Center
Seoul National University Hospital
The Catholic University of Korea
Ajou University
Severance Hospital
Cheil General Hospital and Women's Healthcare Center
SMG-SNU Boramae Medical Center
Pusan National University Yangsan Hospital
Asan Medical Center
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\) male or female patients with 20 years of age or older 2) clinical history of OAB for at least 3 months prior to visit 2 3) more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
Exclusion criteria
* 1\) In clinical trial, female with pregnant, intent to become pregnant or breast-feeding 2)post-voided residual urine volume \> 150ml 3) a history of catheterization due to acute urinary retention 4) a history of pelvic surgery within 6 months 5) 6) 7) a history of neurovascular disease such as Parkinson's disease, cerebral vascular disease, spinal injury or multiple sclerosis 8)patients with indwelling catheter or intermittent catheterization 9) active or recurrent (\>3 episodes per year) urinary tract infection 10) the use of the following medication at least 2 weeks * anticholinergics * Tricyclic antidepressants,anti-epilepsy drug, anti-Parkinson's disease drug, anti-arrythmia drug type I * Chlorpromazine, Thioridazine, Piperazine * MAO inhibitor 11) Patient is currently taking or has taken within the past 4 weeks alpha-blocker for the treatment of benign prostatic hypertrophy 12) Patient is currently taking or has taken within the past 8 weeks 5ARI or estrogen medication 13) Patient is currently using or has used medications with known activities as inhibitors or inducers of cytochrome P4503A4 (CYP3A4)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of the total score in Xerostomia inventory XI from baseline | after 8 weeks of treatment from baseline | 11-item summated rating scale. Respondents were asked to choose one of five responses ('never', scoring 1\ 'very often', 5) total best and worst values: 11 and 49 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global response assessment | after 8 weeks of treatment from baseline | range, 1\ 7 |
| The changes of the total score in overactive bladder symptom score (OABSS) from baseline | after 8 weeks treatment from baseline | total best and worst values: 0 and 15 |
| Visual Analog Scale (VAS) of dry mouth | after 8 weeks treatment from baseline | The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0\ 10) |
Countries
South Korea
Outcome results
None listed