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Trial · NCT05188742

Registered outcomes22

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

ListOutcomeTime frameDescription
PrimaryChanges from baseline to end of treatment (EoT) (Week 20) in OABSSBaseline and Week 20
Changes from baseline to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome). Symptom improvement is defined as OABSS total score decreased by ≥ 3 points at EoT
SecondaryChanges from baseline to Week 12 in OABSSBaseline and Week 12Changes from baseline to Week 12 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome)
SecondaryChanges from baseline to Week 12 and 20/end of treatment (EoT) in IPSSBaseline, and Week 12 and 20Changes from baseline in IPSS (International Prostate Symptom Score) at Week 12 and 20 (a lower IPSS represents a better outcome)
SecondaryChange from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Micturitions per 24 HoursBaseline, and Week 12 and 20
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
SecondaryChange from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Nocturia Episodes per 24 HoursBaseline, and Week 12 and 20
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from a micturition diary in which a patient records for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
SecondaryChange from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Episodes per 24 HoursBaseline, and Week 12 and 20
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) is derived from episodes reocrded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
SecondaryChange from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Incontinence Episodes per 24 HoursBaseline, and Week 12 and 20
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
SecondaryChanges from Week 8 to Week 20 in OABSSWeek 8 to Week 20Changes from Week 8 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
SecondaryChanges from Week 8 to Week 20 in IPSSWeek 8 to Week 20Changes from Week 8 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
SecondaryChanges from Week 8 to Week 20 in Mean Number of Micturitions per 24 HoursWeek 8 to Week 20
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
SecondaryChanges from Week 8 to Week 20 in Mean Number of Nocturia Episodes per 24 HoursWeek 8 to Week 20
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
SecondaryChanges from Week 8 to Week 20 in Mean Number of Urgency Episodes per 24 HoursWeek 8 to Week 20The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
SecondaryChanges from Week 8 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 HoursWeek 8 to Week 20The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
SecondaryChanges from Week 12 to Week 20 in OABSSWeek 12 to Week 20Changes from Week 12 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
SecondaryChanges from Week 12 to Week 20 in IPSSWeek 12 to Week 20Changes from Week 12 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
SecondaryChanges from Week 12 to Week 20 in Mean Number of Micturitions per 24 HoursWeek 12 to Week 20
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
SecondaryChanges from Week 12 to Week 20 in Mean Number of Nocturia Episodes per 24 HoursWeek 12 to Week 20
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
SecondaryChanges from Week 12 to Week 20 in Mean Number of Urgency Episodes per 24 HoursWeek 12 to Week 20The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
SecondaryChanges from Week 12 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 HoursWeek 12 to Week 20The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
SecondaryChanges from baseline to Week 12 and 20/end of treatment (EoT) in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) scoreBaseline, and Week 12 and 20
Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) is a participant-reported instrument consisting of 19 items that assess the degree to which a participant is bothered by OAB symptoms, and the degree of impact of OAB symptoms on daily life. Participants rate each item using a 6-point Likert Scale ranging from "Not at all" to "A very great deal" for the symptom bother items and "none of the time" to "All of the time" for the Health Related Quality of Life (HRQL) items.

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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