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Trial · NCT04693897

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryChange in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment12 weeks
Concentrations of urinary beta-3 adrenoceptor levels will be analyzed for 1)before and after treatment of patients with overactive bladder syndrome treated with Mirabegron; 2)before and after treatment patients with overactive bladder syndrome treated with Solifenacin; 3)patients with urinary tract infection, and 4)control (subjects without lower urinary tract symptoms).
SecondaryEffect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity after 12 weeks of treatment12 weeks
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
SecondaryEffect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity 6 months after treatment.6 months
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
SecondaryChange in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.12 weeks
Individual participant's change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
SecondaryChange in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment6 months
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
SecondaryEffect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.12 weeks
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
SecondaryEffect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.6 months
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
SecondaryThe participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.12 weeks
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
SecondaryThe participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.6 months
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
SecondaryComparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment12 weeks
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
SecondaryComparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment.6 months
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
SecondaryComparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment12 weeks
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
SecondaryComparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment6 months
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
SecondaryEffect on the participant's life after treatment with Mirabegron and Solifenacin after 12 weeks of treatment.12 weeks
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron and Solifenacin after 12 weeks of treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
SecondaryEffect on the participant's life after treatment with Mirabegron and Solifenacin 6 months after treatment.6 months
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron and Solifenacin 6 months after treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
SecondaryThe participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin after 12 weeks of treatment.12 weeks
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron and Solifenacin after 12 weeks of treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
SecondaryThe participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin 6 months after treatment.6 months
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron and Solifenacin 6 months after treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.

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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