Multiple Sclerosis, Urinary Tract Infections, Bladder Dysfunction
Conditions
Keywords
Prophylaxis, Cranberry, Neurogenic bladder
Brief 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.
Detailed description
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.
Interventions
DRUGCranberry
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).
DRUGPlacebo
Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).
Sponsors
Rennes University Hospital
Pierre Fabre Laboratories
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of a first UTI within one year of treatment. | one year |
Secondary
| Measure | Time frame |
|---|---|
| Number of UTI | Determined at M3, M6, M9 and M12 |
| Score on Qualiveen® scale | Determined at M3, M6, M9 and M12 |
| Symptomatology of urinary disorders | Determined at M3, M6, M9 and M12 |
| EDSS score | Determined at M3, M6, M9 and M12 |
| Rate of patients with at least one UTI during the one-year treatment | Determined at M3, M6, M9 and M12 |
| Antibiotics consumption | Determined at M3, M6, M9 and M12 |
| Safety of cranberry | Determined at M3, M6, M9 and M12 |
| Patients' observance to treatment | Determined at M3, M6, M9 and M12 |
| Number of multiple sclerosis attacks | Determined at M3, M6, M9 and M12 |
Countries
France
Outcome results
None listed