Recurrent urine infection in MS

• Research type

  Research Study

• Full title

  A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with Multiple Sclerosis.

• IRAS ID

  30387

• Contact name

  James Malone-Lee

• Eudract number

  2009-017939-18

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  People with MS are very likely to suffer from bladder disorders. 75% experience symptoms of overactive bladder (OAB), which include urinary frequency, night-time voiding, urgency and incontinence. Many also have problems with emptying the bladder and have to use intermittent self-catheterisation. These troubles are overshadowed by the brooding presence of recurrent urinary infection, which exacerbates OAB symptoms substantially. Research on these problems has not been extensive and we should like to improve on that. We have good reasons to believe that the standard techniques for detecting urine infection are not sufficiently sensitive and miss many infections in MS patients. In pilot research, using more sophisticated techniques we have found; (a) evidence of hidden urinary infections in patients with MS and OAB; (b) that these are associated with worse OAB symptoms and (c) treating the presumed infections seems to improve the condition. From our data and others we now believe that bacteria may be hiding in the cells of the bladder, protected from antibiotics and the body??s natural defence mechanisms. We believe that the low-grade inflammation associated with this may be aggravating the bladder which is already affected by the neuropathology of MS.20 patients suffering from MS and overactive bladder symptoms and who are known to have pyuria (presence of white blood cells in the urine) will be recruited to the study to participate in a randomised, placebo controlled, cross-over, proof of concept trial of six weeks of antibiotic treatment of urinary inflammation. We shall use the simple, safe and effective urinary antibiotic Nitrofurantoin macrocystals.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/64

• Date of REC Opinion

  15 Dec 2010

• REC opinion

  Further Information Favourable Opinion