• Rate of patients with at least one UTI during the one-year treatment [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]
• Number of UTI [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]
• Score on Qualiveen® scale [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]
• Symptomatology of urinary disorders [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]
• EDSS score [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]
• Number of multiple sclerosis attacks [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]
• Antibiotics consumption [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]
• Safety of cranberry [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: Yes ]
• Patients' observance to treatment [ Time Frame: Determined at M3, M6, M9 and M12 ] [ Designated as safety issue: No ]

• Determined at M3, M6, M9 and M12:
• - Rate of patients with at least one UTI during the one-year treatment
• - Number of UTI
• - Score on Qualiveen® scale
• - Symptomatology of urinary disorders
• - EDSS score
• - Number of multiple sclerosis attacks
• - Antibiotics consumption
• - Safety of cranberry
• - Patients’ observance to treatment

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.

Bladder dysfunction occurs at some time in 70 to 90% of patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections (UTI), leading to an important morbidity. Cranberry has been traditionally used for the treatment and prevention of UTI and research suggests that its mechanism of action is preventing bacterial adherence to host cell surface membrane.

However, systematic reviews show the small sample sizes and the poor quality of available trials, determining that there is no reliable evidence of effectiveness of cranberry in UTI prophylaxis. Therefore, to assess whether cranberry is effective in reducing UTI in patients with multiple sclerosis, we have designed a randomized, double-blind, placebo-controlled trial. Efficacy will be evaluated on the time to onset of a UTI in the first year of treatment.

• Multiple Sclerosis
• Urinary Tract Infections
• Bladder Dysfunction

• Drug: Cranberry
• Drug: Placebo

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

Exclusion Criteria:

• Regular consumption of cranberry within 3 months before inclusion
• Symptomatic urinary tract infection at inclusion
• Chronic renal failure (creatininemia < 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

• Pierre Fabre Laboratories
• Ministry of Health, France