NCT00280592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P25-P50 for phase_3 multiple-sclerosis

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2008

Enrollment Period

2.2 years

First QC Date

January 20, 2006

Last Update Submit

May 18, 2012

Conditions

Multiple SclerosisUrinary Tract InfectionsBladder Dysfunction

Keywords

ProphylaxisCranberryNeurogenic bladder

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Cranberry

EXPERIMENTAL

Cranberry

Drug: Cranberry

Interventions

CranberryDRUG

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).

Also known as: Vaccinium macrocarpon
Cranberry
PlaceboDRUG

Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Able to undergo evaluation
  • Informed written consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz

Besançon, 25030, France

Location

Service de Médecine Physique et Réadaptation - Hôpital Pellegrin

Bordeaux, 33076, France

Location

Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré

Garches, 92380, France

Location

Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré

Garches, France

Location

Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert

Lomme, 59160, France

Location

Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild

Paris, 75571, France

Location

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE

Ploemeur, 56275, France

Location

Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes

Rennes, 35043, France

Location

Service de médecine physique et réadapation Hopital de Rangueil

Toulouse, 31059, France

Location

Related Publications (3)

  • Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

    PMID: 37947276DERIVED

  • Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

    PMID: 37068952DERIVED

  • Gallien P, Amarenco G, Benoit N, Bonniaud V, Donze C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.

    PMID: 24402038DERIVED

MeSH Terms

Conditions

Multiple SclerosisUrinary Tract InfectionsUrinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeurologic ManifestationsUrinary Bladder DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Michel Reymann, PhD

    CHU Rennes

    STUDY CHAIR

  • Philippe Gallien, MD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 23, 2006

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

October 1, 2008

Last Updated

May 21, 2012

Record last verified: 2008-05

Locations

FR(10)