Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

Phase 3

Completed

• Conditions: Multiple Sclerosis; Urinary Tract Infections; Bladder Dysfunction
• Interventions: Drug: Placebo; Drug: Cranberry

• Registration Number: NCT00280592
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Primary Completion: 2008-03
• Status Verified: 2008-05
• Study Completion: 2008-10
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cranberry	Cranberry	Cranberry

Primary Outcome Measures

Name	Time	Method
Time to onset of a first UTI within one year of treatment.	one year

Secondary Outcome Measures

Name	Time	Method
Rate of patients with at least one UTI during the one-year treatment	Determined at M3, M6, M9 and M12
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
Number of multiple sclerosis attacks	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

Trial Locations

Locations (10)

Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz; 🇫🇷 Besançon, France

Service de Médecine Physique et Réadaptation - Hôpital Pellegrin; 🇫🇷 Bordeaux, 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

Service de médecine physique et réadapation Hopital de Rangueil; 🇫🇷 Toulouse, France

Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré; 🇫🇷 Garches, France

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE; 🇫🇷 Ploemeur, France

Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes; 🇫🇷 Rennes, France

Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré; 🇫🇷 Garches, France

Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou; 🇫🇷 Rennes, France