Trial · NCT01972841
Registered outcomes70
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 70
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and EoT (up to 12 weeks) | An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. |
| Primary | Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | Baseline and EoT (up to 12 weeks) | A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. |
| Secondary | Change From Baseline to EoT in Mean Volume Voided Per Micturition | Baseline and EoT (up to 12 weeks) | The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. |
| Secondary | Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | Baseline and EoT (up to 12 weeks) | The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. |
| Secondary | Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS) | Baseline and EoT (up to 12 weeks) | The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. |
| Secondary | Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT | Weeks 4, 8, 12 and EoT (up to 12 weeks) | The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period. |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes | Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) | |
| Secondary | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8 and 12 | |
| Secondary | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours | Baseline and weeks 4, 8 and 12 | |
| Secondary | Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition | Baseline and weeks 4, 8 and 12 | |
| Secondary | Change From Baseline to EoT in Corrected Micturition Frequency | Baseline and Week 12 | Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. |
| Secondary | Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT | Weeks 4, 8, 12 and EoT (up to 12 weeks) | An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit. |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes | Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) | |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) | The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) | An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. |
| Secondary | Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT | Weeks 4, 8, 12 and EoT (up to 12 weeks) | A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit. |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes | Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks) | |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) | The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. |
| Secondary | Number of Pads Used at Weeks 4, 8, 12 and EoT | Weeks 4, 8 and 12 (up to 12 weeks) | The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit. |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used | Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks) |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01972841/registered