Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)
Multiple Sclerosis is often associated with severe functional deficits resulting in a range of progressive impairments. Approximately 80% of patients have bladder symptoms at the time of diagnosis and up to 97% will have bladder symptoms during the course of the disease. To date, the vast majority of treatment has been centered on the use of medications to control "bladder spasms" and the use of catheters to help patients empty the bladder. There have been very few studies looking at medications like Alfuzosin that may help in controlling bladder symptoms in Multiple Sclerosis. Alfuzosin has been shown to significantly improve voiding symptoms and bladder emptying in patients with prostatic enlargement. There have been no controlled studies yet to determine whether this treatment helps patients with Multiple Sclerosis. The purpose of this study is to determine if Alfuzosin improves bladder symptoms and quality of life in patients with Multiple Sclerosis.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis|
- The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
OBJECTIVE The primary objective of this study is to evaluate the use of Alfuzosin in the treatment of bladder dysfunction in patients with Multiple Sclerosis (MS).
STUDY POPULATION Twenty (20) participants aged 18 years of age who have been diagnosed with Multiple Sclerosis and lower urinary tract symptoms will be treated with Alfuzosin.
DESIGN This is a single institution, non-randomized, non-blinded pilot study of the use of Alfuzosin in the treatment of bladder dysfunction in MS patients. After the initial screening visit patients will be given 10 mg of Alfuzosin to be taken daily once daily.
STUDY INSTRUMENTS The primary end points of this study are a reduction in the ICIQ questionnaires and improvement in uroflow, post-void residual (PVR) and voiding diaries. All patients will have a detailed history and physical examination at the beginning of the study and at 12 weeks follow-up. Women will have a pregnancy test at the beginning of the study. Participants will be given the ICIQ questionnaires, uroflow and PVR at the screening visit and at week 6 and 12. In addition, these patients will be asked to maintain a three day voiding diary prior to week 2 and week 12. Assessments for safety (blood pressure and heart rate) will be collected at baseline and at the last visit. Blood tests will be performed to check for liver, kidney and prostate problems at the baseline visit. Adverse events will be recorded at all visits and when spontaneously reported by the study participants.
DURATION OF STUDY The study will be 12 weeks in duration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688948
|Canada, Nova Scotia|
|QE II Health Science Centre, Halifax Infirmary|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||Jerzy B Gajewski, MD||QEII Health Science Centre|