Trial · NCT05491525
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics | Optimized Treatment Week 24 | |
| Secondary | Change from Baseline in MCC | Optimized Week 12 | |
| Secondary | Change from Baseline in number of overactive detrusor contractions until the end of bladder filling | Optimized Treatment Weeks 12 and 24 | |
| Secondary | Change from Baseline in detrusor pressure at the end of bladder filling | Optimized Treatment Weeks 12 and 24 | |
| Secondary | Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction | Optimized Treatment Weeks 12 and 24 | |
| Secondary | Change from Baseline in bladder compliance (mL/cm H2O) | Optimized Treatment Weeks 12 and 24 | Bladder compliance is calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder |
| Secondary | Change from Baseline in average first morning catheterized volume | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in average catheterized volume per catheterization | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in average maximum catheterized volume per day | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in average maximum catheterized daytime volume | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in average number of leakage episodes per day | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in estimated number of dry (leakage-free) days/ 7 days | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in Pediatric Incontinence Questionnaire (PIN-Q) | through study completion, an average of 52 weeks | PIN-Q is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicating more impact on the quality of life. |
| Secondary | Change from Baseline in Patient Global Impression of Severity (PGI-S) Scale | through study completion, an average of 52 weeks | PGI-S is a 5 point scale that determines the bladder condition of a participant with 0 being really bad and 4 as really good. Higher score indicates better bladder condition. |
| Secondary | Change from Baseline in Clinical Global Impression of Change (CGI-C) Scale | through study completion, an average of 52 weeks | The CGI-C scale is used to determine the degree of change in participant's overall bladder symptoms since the start of the study on Day 1. The scale will be filled by the investigator by ticking on any of the following options: very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse. |
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/NCT05491525/registered