Overview

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)