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Trial · NCT03475706

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryChange from Baseline in mean number of micturitions per 24h at Week 12Micturitions will be assessed prior to randomization and at Week 12 (Visit 6).Micturition events will be recorded by subjects in an eDiary using a smartphone device during 3-day diary periods prior to randomization and at 12 weeks.
SecondaryUrinary Incontinence (1)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
SecondaryUrinary Incontinence (2)Prior to Randomization (Baseline) and at Weeks 4 and 8Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
SecondaryUrinary Incontinence (3)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Proportion of subjects with no episodes of urgency urinary incontinence per 24h.
SecondaryUrinary Incontinence (4)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h.
SecondaryUrinary Incontinence (5)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24h.
SecondaryMicturitions (1)Prior to Randomization (Baseline) and at Weeks 4 and 8Change from Baseline in mean number of micturitions per 24h.
SecondaryMicturitions (2)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Percentage change from Baseline in mean number of micturitions per 24h.
SecondaryMicturitions (3)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Percentage of subjects with \<8 micturitions per 24h.
SecondaryMicturitions (4)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in mean number of nocturnal voids per 24h.
SecondaryUrine Void Volume (1)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in average void volume over 24h.
SecondaryUrine Void Volume (2)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Percentage change from Baseline in average void volume over 24h.
SecondaryUrine Void Volume (3)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in maximum individual void volume over 24h.
SecondaryUrine Void Volume (4)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Percentage change from Baseline in maximum individual void volume over 24h.
SecondaryUrgency (1)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Proportion of subjects with urges with a mean grade of 3 or 4 per 24h.
SecondaryUrgency (2)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence.
SecondaryPatient Reported Outcomes (1)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Patient Perception of Bladder Condition
SecondaryPatient Reported Outcomes (2)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in Symptom Bother Score (OAB-q short form).
SecondaryPatient Reported Outcomes (3)Prior to Randomization (Baseline) and at Weeks 4, 8, and 12Change from Baseline in health-related quality of life (OAB-q short form).

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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