Trial · NCT03572231
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy | Up to 26 weeks | Discontinuation 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). |
| Primary | Time from treatment initiation to switching to another OAB therapy or dose | Up 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. |
| Primary | Proportion of participants who discontinue OAB treatment | Up to 26 weeks | Discontinuation 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). |
| Primary | Proportion of participants who switch to another treatment or dose | Up 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. |
| Secondary | Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score | Baseline, 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. |
| Secondary | Change from baseline in Bladder Assessment Tool (BAT) score | Baseline, 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. |
| Secondary | Change from baseline in Overactive Bladder Symptom Scores (OABSS) score | Baseline, 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. |
| Secondary | Change from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score | Baseline, 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. |
| Secondary | Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Demographic Information | Baseline (up to Day 0) | Demographic information will be collected from participants for analysis. |
| Secondary | Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: OAB Medical History | Baseline (up to Day 0) | OAB medical history will be collected from participants for analysis. |
| Secondary | Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: History of prior drug treatment for OAB | Baseline (up to Day 0) | History of prior drug treatment for OAB will be collected from participants for analysis. |
| Secondary | Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Medical history | Baseline (up to Day 0) | Medical history will be collected from participants for analysis. |
| Secondary | Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medication information | Up to 26 weeks | Concomitant medication will be collected from participants for analysis. |
| Secondary | Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medical conditions | Up to 26 weeks | Participants medical history will be collected from participants for analysis. |
| Secondary | Health Care Resource Utilization (HCRU) related to the management of OAB | Up to 26 weeks | Participant information will be collected by the investigator or designee via the Healthcare Resource Utilization (HCRU) Worksheet at each visit and the data will be retrieved electronically via the electronic case report form (eCRF). The HCRU worksheet consists of 7 questions related to the participants history and treatment of OAB. |
| Secondary | Safety assessed by Adverse Events (AEs) | Up to 26 weeks | An AE is any untoward medical occurrence in a patient or clinical study patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a product, whether or not considered related to the product. Pre-existing conditions that worsen during a study are to be reported as AEs. |
| Secondary | Safety assessed by Serious Adverse Events (SAEs) | Up to 26 weeks | Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. |
| Secondary | Safety assessed by Adverse Drug Reaction (ADR) | Up to 26 weeks | An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship (drug-event) is at least a reasonable possibility. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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