Multiple SclerosisPhase 2/3NCT00688948
Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)
A Phase 2/3 study testing Alfuzosin in people with Multiple Sclerosis and Bladder Dysfunction, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Bladder Dysfunction
- What is being tested?
- Alfuzosin
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Nov 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant should be eighteen years of age or older.
- Participant should have LUTS secondary to Multiple Sclerosis as defined below.
- Participant should have frequency ≥ 8/day and/or incontinence and/or nocturia ≥ 2/night and/or urgency and/or urinary retention.
- Participant should be able to understand, speak and read English.
- Participant 's urine culture should not show any evidence of urinary tract infection.
- Participant should be willing to take part in the study and sign the consent form.
- Female participants consents to use a medically acceptable method of birth control throughout the entire study period and for four weeks after the study is completed. Medically acceptable methods of contraception that may be used by the study participants and/or their partner includes abstinence, birth control pills or patches, diaphragm with spermicide, IUD, condom and vaginal spermicide, surgical sterilization, vasectomy, progestin implants or injections.
Who cannot join
- Participant with known hypersensitivity to Alfuzosin.
- Participant with history of postural hypotension and/or syncope.
- Participant has used another alpha blocker within the last 30 days.
- Participant has active urethral stricture disease.
- Participant has a history of prostate cancer within the preceding five years.
- Participant has hepatic dysfunction.
Show all 16Show fewer
- Participant has renal dysfunction.
- Participant has unstable angina pectoris.
- Participant has a positive pregnancy test at the time of screening.
- Participant has a history of serious social, mental or medical conditions that would stop patient from taking part in the study.
- Participant has a history of alcohol or drug abuse within the last five years.
- Participant who is currently being treated for chronic bacterial prostatitis or painful bladder syndrome/interstitial cystitis.
- Participant has a significant medical problem which the investigator considers a serious risk for the patient to be part of the study.
- Use of any investigational drug or device within the last 6 months.
- Participant who is unwilling or unable to abide by the requirements of study.
- Participant has a bladder infection proven by urine culture.
Trial locations and contacts
1 site in 1 country.
Canada1 site
QE II Health Science Centre, Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, Bladder Dysfunction
- Being tested
- Alfuzosin
- Keywords
- pilot clinical trial
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
Also called Xatral
Alfuzosin 10 mg once daily po for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Jerzy B Gajewski, MD, Principal investigator, QEII Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688948
- Sponsor's protocol ID
- CDHA-RS/2007-035
- Other IDs
- JBGMS01
- Status last verified
- Feb 2009
- First submitted
- 30 May 2008
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00688948
- Acronym / sponsor ID
- CDHA-RS/2007-035
- Conditions
- Multiple Sclerosis, Bladder Dysfunction
- Keywords
- pilot clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant should be eighteen years of age or older.
- Participant should have LUTS secondary to Multiple Sclerosis as defined below.
- Participant should have frequency ≥ 8/day and/or incontinence and/or nocturia ≥ 2/night and/or urgency and/or urinary retention.
- Participant should be able to understand, speak and read English.
- Participant 's urine culture should not show any evidence of urinary tract infection.
Key exclusion criteria (16 listed)
- Participant with known hypersensitivity to Alfuzosin.
- Participant with history of postural hypotension and/or syncope.
- Participant has used another alpha blocker within the last 30 days.
- Participant has active urethral stricture disease.
- Participant has a history of prostate cancer within the preceding five years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfuzosinAlso: XatralAlfuzosin 10 mg once daily po for 12 weeks | Drug | – |
Primary outcome
The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerzy B Gajewski, MD principal investigator
QEII Health Science Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alfuzosin in people with Multiple Sclerosis and Bladder Dysfunction, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.