Clinical trial NCT01437670: Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
Official title: A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Seoul National University Hospital
name: The Catholic University of Korea
name: Ajou University
name: Severance Hospital
name: Cheil General Hospital and Women's Healthcare Center
name: SMG-SNU Boramae Medical Center
name: Pusan National University Yangsan Hospital
First posted: 2011-09-21
Enrollment: 262
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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

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

Eligibility 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)

Primary outcomes:
measure: The changes of the total score in Xerostomia inventory XI from baseline
timeFrame: after 8 weeks of treatment from baseline
Secondary outcomes:
measure: Global response assessment
timeFrame: after 8 weeks of treatment from baseline
measure: The changes of the total score in overactive bladder symptom score (OABSS) from baseline
timeFrame: after 8 weeks treatment from baseline
measure: Visual Analog Scale (VAS) of dry mouth
timeFrame: after 8 weeks treatment from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Myoung-Soo Choo, M.D., pH.D.
role: PRINCIPAL_INVESTIGATOR
References: