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

A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: solifenacin 5mg, 10mg

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-222
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with overactive bladder

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dry mouth patients with solifenacin; dry mouth patients with solifenacin 5mg, 10mg	Drug: solifenacin 5mg, 10mg; solifenacin 5mg, 10mg; Other Names: Vesicare

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of the total score in Xerostomia inventory XI 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	after 8 weeks of treatment from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global response assessment	range, 1~7	after 8 weeks of treatment from baseline
The changes of the total score in overactive bladder symptom score (OABSS) from baseline	total best and worst values: 0 and 15	after 8 weeks treatment from baseline
Visual Analog Scale (VAS) of dry mouth	The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0~10)	after 8 weeks treatment from baseline

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Samsung Medical Center; Seoul National University Hospital; Cheil General Hospital and Women's Healthcare Center; SMG-SNU Boramae Medical Center; The Catholic University of Korea; Severance Hospital; Pusan National University Yangsan Hospital; Ajou University
• Investigators: Principal Investigator: Myoung-Soo Choo, M.D., pH.D., Asan Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (ESTIMATE): September 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 30, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: AMC 2011-0585