Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00688948
• Date of registration: 30/05/2008
• Prospective Registration: No
• Primary sponsor: Capital District Health Authority, Canada
• Public title: Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)
• Scientific title: A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis
• Date of first enrolment: November 2007
• Target sample size: 20
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00688948
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: Jerzy B Gajewski, MD
• Affiliation: QEII Health Science Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Participant should be eighteen years of age or older.

2. Participant should have LUTS secondary to Multiple Sclerosis as defined below.

3. Participant should have frequency = 8/day and/or incontinence and/or nocturia =
2/night and/or urgency and/or urinary retention.

4. Participant should be able to understand, speak and read English.

5. Participant 's urine culture should not show any evidence of urinary tract infection.

6. Participant should be willing to take part in the study and sign the consent form.

7. 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.

Exclusion Criteria:

1. Participant with known hypersensitivity to Alfuzosin.

2. Participant with history of postural hypotension and/or syncope.

3. Participant has used another alpha blocker within the last 30 days.

4. Participant has active urethral stricture disease.

5. Participant has a history of prostate cancer within the preceding five years.

6. Participant has hepatic dysfunction.

7. Participant has renal dysfunction.

8. Participant has unstable angina pectoris.

9. Participant has a positive pregnancy test at the time of screening.

10. Participant has a history of serious social, mental or medical conditions that would
stop patient from taking part in the study.

11. Participant has a history of alcohol or drug abuse within the last five years.

12. Participant who is currently being treated for chronic bacterial prostatitis or
painful bladder syndrome/interstitial cystitis.

13. Participant has a significant medical problem which the investigator considers a
serious risk for the patient to be part of the study.

14. Use of any investigational drug or device within the last 6 months.

15. Participant who is unwilling or unable to abide by the requirements of study.

16. Participant has a bladder infection proven by urine culture.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Bladder Dysfunction

Intervention(s)

Drug: Alfuzosin

Primary Outcome(s)

The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries. [Time Frame: 12 weeks]

Secondary ID(s)

JBGMS01

CDHA-RS/2007-035

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi