Trial · NCT03594058
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in mean number of micturitions per 24 hours at Week 12 | Micturtions 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. |
| Secondary | Urinary Incontinence (1) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours |
| Secondary | Urinary Incontinence (2) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours |
| Secondary | Urinary Incontinence (3) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Proportion of subjects with no episodes of urgency urinary incontinence per 24 hours |
| Secondary | Urinary Incontinence (4) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Proportion of subjects with no episodes of urinary incontinence (urgency and non-urgency) per 24 hours |
| Secondary | Urinary Incontinence (5) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24 hours |
| Secondary | Micturitions (1) | Prior to Randomization (Baseline) and at Weeks 4 and 8 | Change from Baseline in mean number of micturitions per 24 hours |
| Secondary | Micturitions (2) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage change from Baseline in mean number of micturitions per 24 hours |
| Secondary | Micturitions (3) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage of subjects with \< 8 micturitions per 24 hours |
| Secondary | Micturitions (4) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in mean number of nocturnal voids per 24 hours |
| Secondary | Urine Void Volume (1) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in average void volume over 24 hours |
| Secondary | Urine Void Volume (2) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage change from Baseline in average void volume over 24 hours |
| Secondary | Urine Void Volume (3) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in maximum individual void volume over 24 hours |
| Secondary | Urine Void Volume (4) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage change from Baseline in maximum individual void volume over 24 hours |
| Secondary | Urgency (1) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Proportion of subjects with urges with a mean grade of 3 of 4 per 24 hours |
| Secondary | Urgency (2) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in mean urgency assessments per 24 hours associated with micturitions or incontinence |
| Secondary | Patient Reported Outcomes (1) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Patient Perception of Bladder Control. This patient-reported questionnaire assesses the patient's perception of current urinary problems, where higher score (on a scale of 1 to 6) indicates more severe problems. |
| Secondary | Patient Reported Outcomes (2) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in Symptom Bother Score (Overactive Bladder Questionnaire \[OAB-q\] short form). The OAB-q short form is completed as a 4-week recall where a higher score (on a scale of 1 to 6) indicates greater symptoms. |
| Secondary | Patient Reported Outcomes (3) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in health-related quality of life (Overactive Bladder Questionnaire \[OAB-q\] short form). The OAB-q short form is completed as a 4-week recall where a higher score (on a scale of 1 to 6) indicates worse health-related quality of life. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03594058/registered