Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)

NCT00688948 | Terminated Phase 2

• 2 other identifiers: CDHA-RS/2007-035JBGMS01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis; Bladder Dysfunction

Keywords

pilot clinical trial

Outcome Measures

Primary Outcomes (1)

• The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries.

  12 weeks

Interventions

Alfuzosin DRUG

Alfuzosin 10 mg once daily po for 12 weeks

Also known as: Xatral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Sanofi: collaborator

Study Sites (1)

QE II Health Science Centre, Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jerzy B Gajewski, MD

  QEII Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: November 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 27, 2011

Record last verified: 2009-02

Locations

CA (1)