A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function (TRUST)
A recent report has demonstrated improvements in QoL parameters in patients receiving TYSABRI® (Rudick et al, 2007). This observation, coupled with anecdotal reports and our own experience, lead us to hypothesize that TYSABRI® will have a demonstrable beneficial effect on improving patient's bladder function as defined by changes in baseline to month 6 scores on the UDI-6 and also on patient reported incontinence episodes and micturitions per day.
Relapsing Remitting Multiple Sclerosis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Bladder Function in Relapsing Remitting Multiple Sclerosis Patients Treated With Natalizumab (TYSABRI)|
- Change in bladder function as measured by UDI-6 compared to baseline over 6 months of TYSABRI® treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change from baseline over 6 months of TYSABRI® treatment in the number of urinary incontinence episodes per patient per week. Mean change from baseline over 6 months of TYSABRI® treatment in the number of micturitions per patient per day. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Patients who are newly prescribed TYSABRI®, but have not received their first infusion, will be invited to participate.