Status:
COMPLETED
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Samsung Medical Center
Seoul National University Hospital
Conditions:
Overactive Bladder
Eligibility:
All Genders
20+ years
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT01437670
Start Date
September 1 2011
End Date
December 1 2013
Last Update
May 30 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, Seoul, South Korea, 138-222