Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)
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|ClinicalTrials.gov Identifier: NCT00688948|
Recruitment Status : Terminated (Lack of funding)
First Posted : June 3, 2008
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Bladder Dysfunction||Drug: Alfuzosin||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
- The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|