Feasibility of "At-home" Titration of Solifenacin
This study has been terminated.
(difficulty with enrollment)
New York University School of Medicine
First Posted: September 25, 2008
Last Update Posted: October 26, 2015
Information provided by (Responsible Party):
Benjamin Brucker, New York University School of Medicine
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Feasibility of "At-home" Titration of Solifenacin 5 and 10mg and Effect on Symptoms and Quality of Life in a Typical OAB Population|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Benjamin Brucker, New York University School of Medicine:
Primary Outcome Measures:
- Improvement in Patient Perception of Bladder Condition Score (PPBC) [ Time Frame: 12 weeks ]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.
|Study Start Date:||September 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Patients were given drug to self titrate
5mg and 10 mg, oral once daily
Other Name: Vesicare
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.
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