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

Asan Medical Center

Status: Completed

Conditions: Overactive Bladder

Treatments: Drug: solifenacin 5mg, 10mg

Study type: Observational

Funder types: Other

Identifiers

NCT01437670

AMC 2011-0585

Details and patient eligibility

About

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

Full description

To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin

Enrollment: 262 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

262 participants in 1 patient group

dry mouth patients with solifenacin

Description:

dry mouth patients with solifenacin 5mg, 10mg

Treatment:

Drug: solifenacin 5mg, 10mg