A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis
Data Collection
Autoimmune Diseases+4
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: November 1, 2007
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
QE II Health Science Centre, Halifax Infirmary
Halifax, CanadaOpen QE II Health Science Centre, Halifax Infirmary in Google Maps