Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Ajou University; Cheil General Hospital and Women's Healthcare Center; Cheil General Hospital and Women’s Healthcare Center; Pusan National University Yangsan Hospital; Samsung Medical Center; Seoul National University Hospital; Severance Hospital; SMG-SNU Boramae Medical Center; The Catholic University of Korea
• Treatments: Solifenacin Succinate

Criteria

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)