Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Collaborators: Ministry of Health, France; Pierre Fabre Laboratories

Criteria

Inclusion Criteria:

• Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months

• With an EDSS score ≥ 3

• Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not

• Ambulatory at inclusion

• Able to undergo evaluation

• Informed written consent

Non-inclusion Criteria:

• Regular consumption of cranberry within 3 months before inclusion

• Symptomatic urinary tract infection at inclusion

• Chronic renal failure (creatinin clearance < 10ml/min)

• Patients with urinary permanent catheterization

• Patients with hyperuricemia and risk of uric acid lithiasis

• Patients with oral anticoagulant treatment (antivitamins K)

• Peptic ulcer

• Intolerance to cranberry and/or excipients

• Urinary tract infections antibioprophylaxis