Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.

CompletedPhase 3MS (type not specified)NCT00280592

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Cranberry

Placebo

  • Placebo

What it measured

Main measures

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

    one year

Other measures (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

    Bladder, bowel and sexual function
  • EDSS score

    Determined at M3, M6, M9 and M12

    Disability progression
  • Number of multiple sclerosis attacks

    Determined at M3, M6, M9 and M12

    Relapses
  • Antibiotics consumption

    Determined at M3, M6, M9 and M12

  • Safety of cranberry

    Determined at M3, M6, M9 and M12

    Safety
  • Patients' observance to treatment

    Determined at M3, M6, M9 and M12

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

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 separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jan 2006

    2. Main results due

      Mar 2008

    3. Finished

      Oct 2008

    Assembled by software from public sources.