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

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: solifenacin 5mg, 10mg

• Registration Number: NCT01437670
• Lead Sponsor: Asan Medical Center

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

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dry mouth patients with solifenacin	solifenacin 5mg, 10mg	dry mouth patients with solifenacin 5mg, 10mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of