Registered outcomes15

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

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	Baseline to Week 8 (8 weeks in treatment period)
Primary	Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8	Baseline to Week 8 (8 weeks in treatment period)
Secondary	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4	Baseline to Week 4 (4 weeks in treatment period)
Secondary	Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4	Baseline to Week 4 (4 weeks in treatment period)
Secondary	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup	Baseline to Week 4 (4 weeks in treatment period)
Secondary	Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup	Baseline to Week 4 (4 weeks in treatment period)
Secondary	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup	Baseline to Week 8 (8 weeks in treatment period)
Secondary	Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup	Baseline to Week 8 (8 weeks in treatment period)
Secondary	Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period	At Week 8 in the treatment period
Secondary	Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8	Baseline to Week 8 (8 weeks in treatment period)	PGI-I was used to evaluate the patients' impression of improvement of urinary incontinence. The improvement of PGI-I was defined as the selection of "Very much better", "Much better", or "A little better". The investigator or subinvestigator instructed patients to evaluate the improvement of urinary incontinence at the evaluation time point using the following 7-point scale: (1) "Very much better"; (2) "Much better"; (3) "A little better"; (4) "No change"; (5) "A little worse"; (6) "Much worse"; and (7) "Very much worse".
Secondary	Any Adverse Events	Baseline to Week 8 (8 weeks in treatment period)	For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Secondary	Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period	Baseline to Week 8 (8 weeks in treatment period)	For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Secondary	Adverse Drug Reactions	Baseline to Week 8 (8 weeks in treatment period)	For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Secondary	Serious Adverse Events	Baseline to Week 8 (8 weeks in treatment period)
Secondary	Adverse Events Leading to Discontinuation of Administration	Baseline to Week 8 (8 weeks in treatment period)

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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