Trial · NCT07391878
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Number of Micturitions per 24 Hours | Baseline to Week 12 | Change from baseline in the average number of micturitions per 24 hours, as recorded in a 3-day patient voiding diary. |
| Primary | Change From Baseline in Average Number of Urgency Episodes per 24 Hours | Baseline to Week 12 | Change from baseline in the average number of urgency episodes (defined as a sudden and compelling desire to void) per 24 hours, based on the 3-day patient voiding diary. |
| Primary | Change From Baseline in Average Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours | Baseline to Week 12 | Change from baseline in the average number of urgency urinary incontinence (UUI) episodes per 24 hours, as recorded in the 3-day patient voiding diary. |
| Secondary | Proportion of Participants With ≥50% Reduction in Micturitions per 24 Hours | Baseline to Week 12 | Proportion of participants achieving at least a 50% reduction from baseline in the average number of micturitions per 24 hours, based on the 3-day patient voiding diary. |
| Secondary | Proportion of Participants With ≥50% Reduction in Urgency Episodes per 24 Hours | Baseline to Week 12 | Proportion of participants achieving at least a 50% reduction from baseline in the average number of urgency episodes per 24 hours, based on the 3-day patient voiding diary. |
| Secondary | Proportion of Participants With ≥50% Reduction in Urgency Urinary Incontinence (UUI) Episodes | Baseline to Week 12 | Proportion of participants achieving at least a 50% reduction from baseline in the average number of urgency urinary incontinence (UUI) episodes per 24 hours. |
| Secondary | Change From Baseline in Nocturnal Voids per Night | Baseline to Week 12 | Change from baseline in the average number of nocturnal voids per night, as recorded in the 3-day patient voiding diary. |
| Secondary | Change From Baseline in Average Voided Volume | Baseline to Week 12 | Change from baseline in average voided volume (mL), measured using a calibrated measuring device and recorded in the patient voiding diary. |
| Secondary | Change From Baseline in Quality of Life Score | Baseline to Week 12 | Change from baseline to Week 12 in quality of life related to lower urinary tract symptoms, assessed using the LUTN questionnaire total score. The LUTN questionnaire total score ranges from 0 to 100, with higher scores indicating greater symptom burden and poorer quality of life, and lower scores indicating improvement. The outcome measure will be reported as the mean change from baseline. |
| Secondary | Improvement in Patient Perception of Bladder Condition (PPBC) | Baseline to Week 12 | Proportion of participants achieving an improvement of at least 1 point on the 6-point Patient Perception of Bladder Condition (PPBC) scale. |
| Secondary | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose through End of Study (Week 12) | Incidence, severity, and relationship to study treatment of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be assessed from first dose through Week 12. Events will be coded using MedDRA and summarized by system organ class, preferred term, severity (mild, moderate, severe), and relationship to study treatment. |
| Secondary | Change From Baseline in Vital Signs (Blood Pressure, Heart Rate, and Body Temperature) | Baseline to Week 12 | Change from baseline to Week 12 in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats per minute), and body temperature (°C). Results will be summarized as mean change from baseline for each parameter. |
| Secondary | Change From Baseline in Clinical Laboratory Safety Parameters | Baseline to Week 12 | Change from baseline to Week 12 in clinical laboratory parameters including hematology (hemoglobin, white blood cell count, platelet count) and serum chemistry (creatinine, ALT, AST). Results will be summarized as mean change from baseline and incidence of values outside the normal reference range. |
| Secondary | Change From Baseline in Post-Void Residual Urine Volume | Baseline to Week 12 | Change from baseline to Week 12 in post-void residual (PVR) urine volume, measured in milliliters (mL) using bladder ultrasound. Results will be summarized as mean change from baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT07391878/registered