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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
171
Dry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day (in the morning and in the evening).
Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).
Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
Besançon, France
Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
Bordeaux, France
Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
Garches, France
Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré
Garches, France
Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert
Lomme, France
Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild
Paris, France
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
Ploemeur, France
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Rennes, France
Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes
Rennes, France
Service de médecine physique et réadapation Hopital de Rangueil
Toulouse, France
Time to onset of a first UTI within one year of treatment.
Time frame: one year
Rate of patients with at least one UTI during the one-year treatment
Time frame: Determined at M3, M6, M9 and M12
Number of UTI
Time frame: Determined at M3, M6, M9 and M12
Score on Qualiveen® scale
Time frame: Determined at M3, M6, M9 and M12
Symptomatology of urinary disorders
Time frame: Determined at M3, M6, M9 and M12
EDSS score
Time frame: Determined at M3, M6, M9 and M12
Number of multiple sclerosis attacks
Time frame: Determined at M3, M6, M9 and M12
Antibiotics consumption
Time frame: Determined at M3, M6, M9 and M12
Safety of cranberry
Time frame: Determined at M3, M6, M9 and M12
Patients' observance to treatment
Time frame: Determined at M3, M6, M9 and M12
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