Clinical trial NCT00985387: Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients
Official title: Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder, Overactive
Overactive Bladder
Keywords: Solifenacin
Overactive bladder
persistency of the treatment
Vesicare
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2009-09-28
Enrollment: 1215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OAB patients who were treated with solifenacin

Brief summary: The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Overactive bladder symptoms lasting for more than 3 months
* The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
* Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)

Exclusion Criteria:

* Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
* Symptomatic acute urinary tract infection (UTI)
* Diagnosed or suspected of interstitial cystitis
* Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
* Pregnant or nursing women
* Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs
* Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Primary outcomes:
measure: percentage of patients who are maintaining solifenacin treatment
timeFrame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
Secondary outcomes:
measure: percentage of patients who discontinued solifenacin treatment
timeFrame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
measure: percentage of patients who switched to other OAB medication
timeFrame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
city: Bucheon
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Chonju
country: Korea, Republic of
city: Chonju
country: Korea, Republic of
city: Chuncheon
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gangneung
country: Korea, Republic of
city: Gumi-si
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyongju
country: Korea, Republic of
city: Hwasun
country: Korea, Republic of
city: Iksan
country: Korea, Republic of
city: Inchon
country: Korea, Republic of
city: Inchon
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Masan
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: