Trial Outcomes & Findings for Feasibility of "At-home" Titration of Solifenacin (NCT NCT00759577)
NCT ID: NCT00759577
Last Updated: 2015-10-26
Results Overview
Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.
TERMINATED
PHASE4
36 participants
12 weeks
2015-10-26
Participant Flow
Of the planned 100 patients to be enrolled only 36 were enrolled.
Participant milestones
| Measure |
At Home Titration
Starting with 5mg of solifenacin by mouth daily with self-titration ("at home") up 10mg of solifenacin by mouth daily.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of "At-home" Titration of Solifenacin
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 12 weeksPopulation: There was no questionnaire available for analysis. Secondary to poor enrollment the study was stopped and efforts to collect questionnaires at an earlier time point were not carried out.
Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.
Outcome measures
Outcome data not reported
Adverse Events
At Home Titration
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place