A Phase 4 interventional study of Solifenacin in Overactive Bladder, sponsored by NYU Langone Health. Terminated. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-26.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment
This is an open-label single center trial to study improvements in symptom bother and quality of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is designed to reflect real world conditions in typical male and female OAB patients presenting for treatment.
Open-label single center trial to study improvements in symptom bother and quality of life in OAB patients self titrating solifenacin 5mg and 10 mg. The study was designed to reflect real world conditions in typical male and female OAB patients presenting for treatment. After eligibility was confirmed, subjects completed a number of questionnaires which include patient perception of bladder condition (PPBC)12, Overactive Bladder Questionaire (OAB-q13), visual analog scale (VAS) 0-100 assessing bother of urge incontinence, urgency, frequency and nocturia over the past week.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 36 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients were given drug to self titrate
Drug: Solifenacin
5mg and 10 mg, oral once daily
Also known as: Vesicare
Improvement in Patient Perception of Bladder Condition Score (PPBC)
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.
Time frame: 12 weeks
Of the planned 100 patients to be enrolled only 36 were enrolled.
| Milestone | At Home Titration |
|---|---|
| Started | 36 |
| Completed | 36 |
| Not completed | 0 |
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.
No measurements were reported for this outcome.
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| At Home Titration | — | — | — |
| Age, Categorical(Participants) | At Home Titration |
|---|
| Sex: Female, Male(Participants) | At Home Titration |
|---|
No study locations are listed for this record.
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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