Nitrofurantoin Study
Many people with MS experience overactive bladder (OAB) symptoms, which
include having to pass urine very frequently, urinary ‘urgency’, which means
having to rush to get to the toilet, and leaking urine. In some patients with these
symptoms, the urine shows signs that the bladder is inflamed, and although
infection is a recognised cause of such inflammation, routine tests for infection
are often negative. Some research has raised doubts about the accuracy of
standard tests for infection.
Nitrofurantoin is an antibiotic which is commonly used to treat urine infections.
The purpose of this study is to test the effects of a longer course of antibiotic
treatment in patients with OAB symptoms and signs of bladder inflammation,
even when routine tests for infection are negative.
Recruitment dates
Start date: April 2012
End date: April 2013
Phase
This is a phase IV trial.
Who can enter the trial
To be eligible to take part you must satisfy the following criteria:
You are aged over 18 years and have been diagnosed with MS
You experience urinary urgency, with or without leakage
You are able to fill in a bladder diary and study questionnaire
Your urine contains 10 or more pus cells when we examine it under the
microscope, indicating bladder inflammation
- Your routine urine culture sent to the laboratory comes back negative
- You are capable of providing informed consent to enter the study
-
You may not take part in the study if:
-
You are pregnant or breastfeeding (males and females will use
contraception during the trial)
You are taking part in other research, or have been involved in a research
project in the last six months
You have taken part in previous clinical trials testing nitrofurantoin
You have an allergy to nitrofurantoin
You have kidney problems or longstanding lung disease
You have the condition ‘glucose-6-phosphate deficiency’ or ‘porphyria’
-
You are intolerant of lactose
You currently use of other medicines which may react with our study drug.
These include: magnesium trisilicate, sulphinpyrazone, probenecid,
nalidixic acid, carbonic anhydrase inhibitors, and quinolone antibiotics.
Trial design
Twenty people will take part in the trial.
This is a randomised, double-blind, placebo-controlled trial. The trial has a ‘crossover’ design, which means that everyone will be treated with antibiotics for 6
weeks and a placebo (‘dummy drug’) for 6 weeks during the study. The
treatments will be separated by a break of at least a month, and neither the
participants, nor the research staff, will know which treatment is being given
when.
How many times (and how often) they have treatment
All participants will visit the research centre for a screening visit. The research
team will make sure that you are eligible to take part, which will include analysis
of a urine sample. If you are eligible, you will be asked to return within two weeks
to start the trial.
Each participant will be asked to take the antibiotic study drug, nitrofurantoin,
twice daily for six weeks, and, after a short break, take a placebo twice daily for
six weeks. Neither you, nor the research staff, will know which in which order the
medication is being given. In each six week treatment block, you will be asked to
visit the research centre every two weeks, where you will fill in a questionnaire,
and provide a sample of urine for analysis. You will be asked to complete a
‘bladder diary’ before each visit, which will record how often you visit the toilet,
and how much urine you pass.
Side effects
Nitrofurantoin is commonly used in the treatment of urinary infections, and has
been fully licensed by drug regulatory agencies in the UK for decades. It is
generally well tolerated by patients, although like any medication, some minor
side effects are relatively common. Nausea and indigestion may occur, especially
when the drug is taken on an empty stomach. Other potential side effects are
diarrhoea, and the development of a rash. Severe allergy is extremely rare.
Location of trial
The trial is taking place at the Department of Medicine, Whittington Hospital,
North London.
Contact details
If you are interested in finding out more about this trial, please contact Dr
Anthony Kupelian. Telephone 020 7288 3649 or 020 7288 5301, or email to
a.kupelian@ucl.ac.uk
Chief investigator
Prof James Malone-Lee, University College London
Supported by
The MS Society