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Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00985387
Enrollment
1215
Registered
2009-09-28
Start date
2009-08-31
Completion date
2011-08-31
Last updated
2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Urinary Bladder, Overactive

Keywords

Solifenacin, Overactive bladder, persistency of the treatment, Vesicare

Brief summary

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

Interventions

DRUGSolifenacin

oral

Sponsors

Astellas Pharma Korea, Inc.
CollaboratorINDUSTRY
Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
percentage of patients who are maintaining solifenacin treatmentMonth 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Secondary

MeasureTime frame
percentage of patients who discontinued solifenacin treatmentMonth 0, Month 1, Month 3, Month 6, Month 9 and Month 12
percentage of patients who switched to other OAB medicationMonth 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026