Status:
COMPLETED
Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Pierre Fabre Laboratories
Ministry of Health, France
Conditions:
Multiple Sclerosis
Urinary Tract Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
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 morbidit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00280592
Start Date
January 1 2006
End Date
October 1 2008
Last Update
May 21 2012
Active Locations (10)
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1
Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
Besançon, France, 25030
2
Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
Bordeaux, France, 33076
3
Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
Garches, France, 92380
4
Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré
Garches, France