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Trial · NCT03572231

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

NCT03572231, Completed, Astellas Pharma Singapore Pte. Ltd.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China. Trials, record NCT03572231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03572231

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
NCT number
NCT03572231
Status
Completed
Enrollment
805 participants, actual
Lead sponsor
Astellas Pharma Singapore Pte. Ltd.
Conditions
Overactive Bladder (OAB)
Interventions
mirabegron, solifenacin, darifenacin, imidafenacin, tolterodine, oxybutynin, trospium, fesoterodine, propiverine
First posted
2018-06-28
Last updated
2020-04-22

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime from treatment initiation to discontinuation of Overactive Bladder (OAB) therapyUp to 26 weeksDiscontinuation will include participants who discontinue mirabegron or antimuscarinics for more than 30 days (defined as the day after the last day of the prior supply to the next dispensing date).
PrimaryTime from treatment initiation to switching to another OAB therapy or doseUp to 26 weeks
Switching will be defined as a subset of initial mirabegron or antimuscarinics discontinuers who initiated another/different therapy(ies) within the follow-up period or within 30 days of being prescribed the first treatment. Change of treatment to another formulation of the same drug type under the same dosage will not be considered as switching.
PrimaryProportion of participants who discontinue OAB treatmentUp to 26 weeksDiscontinuation will include participants who discontinue mirabegron or antimuscarinics for more than 30 days (defined as the day after the last day of the prior supply to the next dispensing date).
PrimaryProportion of participants who switch to another treatment or doseUp to 26 weeks
Switching will be defined as a subset of initial mirabegron or antimuscarinics discontinuers who initiated another/different therapy(ies) within the follow-up period or within 30 days of being prescribed the first treatment. Change of treatment to another formulation of the same drug type under the same dosage will not be considered as switching.
SecondaryChange from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) scoreBaseline, weeks 10-14 and weeks 22-26
Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) is a participant-reported instrument consisting of 19 items that assess the degree to which a participant is bothered by OAB symptoms, and the degree of impact of OAB symptoms on daily life. Participants rate each item using a 6-point Likert Scale ranging from "Not at all" to "A very great deal" for the symptom bother items and "none of the time" to "All of the time" for the Health Related Quality of Life (HRQL) items.
SecondaryChange from baseline in Bladder Assessment Tool (BAT) scoreBaseline, weeks 10-14 and weeks 22-26
Bladder Assessment Tool (BAT) is a participant-reported instrument consisting of 17 questions regarding the symptoms, bothering, impacts and treatment satisfaction in the past 7 days. Scores range from 0 to 88, a reduction in BAT score indicates an improvement.
SecondaryChange from baseline in Overactive Bladder Symptom Scores (OABSS) scoreBaseline, weeks 10-14 and weeks 22-26
Overactive Bladder Symptom Scores (OABSS) is a participant-reported instrument consisting of 4 questions regarding daytime frequency, nocturia, urgency, and urgency incontinence; evaluates relevant symptoms from the participant's viewpoint. Scores range from 0 to 15 with a lower score indicating a mild presentation of overactive bladder syndrome and a higher score indicating moderate to severe presentation of overactive bladder syndrome.
SecondaryChange from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) scoreBaseline, weeks 10-14 and weeks 22-26
Treatment Satisfaction-Visual Analog Scale (TS-VAS) is a quantitative instrument assessing participant improvement in participants with OAB. A score of 10 on the TS-VAS indicates complete satisfaction, whereas a positive change from baseline indicates improvement.
SecondaryIdentify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Demographic InformationBaseline (up to Day 0)Demographic information will be collected from participants for analysis.
SecondaryIdentify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: OAB Medical HistoryBaseline (up to Day 0)OAB medical history will be collected from participants for analysis.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
37148497DERIVEDPubMed
38430402DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03572231

GET https://conductscience.org/api/trials/v1/NCT03572231/registered