Hypothesis / aims of study
Patients with neurogenic bladders are more prone to urinary tract infections and their life-long prevention and treatment is challenging e specially in the face of emerging antibiotic resistance worldwide. (1) (2)
MICRODOX is an electrolysed bladder rinse solution intended for use as an adjunct in the treatment and prevention of urinary tract infection and registered as a TGA approved medical device in Australia and New Zealand. It uses Microdacyn Super Oxidised Hypochlorous Acid Solution (SOS) as the active ingredient, a formula that has been successful in wound care in clinical use.(3)
The use of hypochlorous acid derived solutions with proven antimicrobial efficacy has demonstrated effectiveness in resolving problematic CAUTI including multi-drug resistant infection with no promotion of bacterial resistance. Its purpose is the removal of UTI causing bacteria from the bladder lining, known as biofilm, thus leading to a reduction in urinary tract infection in catheter dependent patients.
Whilst extensively studied in vitro, no human efficacy data is available in the literature to date.
We present our initial clinical review of neuropathic patients using weekly MICRODOX washouts and report their preliminary results.
The primary end point of this review is reduction in symptomatic CAUTI, the secondary end point is reduced blockage of indwelling catheters.
Study design, materials and methods
We retrospectively reviewed data of patients commenced on MICRODOX washouts within the last 12 months. Included were only neuropathic patients who are catheter dependent, either by intermittent or long-term indwelling catheters.
Patients were commenced on a weekly regime of 2 subsequent wash outs with 30ml of MICRODOX solution left in situ for 10min before drainage. Indications for treatment were recurrent CAUTI despite other preventative treatment attempts including Hiprex, Vitamin C and D-mannose. Additional indications were frequent indwelling catheter blockages with or without associated symptoms of CAUTI.
Included parameters for review were urine culture results prior to commencing washouts and at 8 weeks. Phone interviews were conducted to assess symptomatic improvement and any noted adverse effects as well as self reported UTI. Hospital records were accessed to review microbiology results and dates of nurse led catheter changes in the community
Results
A total of 18 patients were included in this review, 9 males and 9 females. The median age is 57 (29 to 82). A summary of underlying condition, type of bladder management and indication for treatment can be found in chart 1.
Chart 1: relevant patient demographics
All patients submitted a CSU prior to commencing MICRODOX this included patients with symptomatic CAUTI at the time of consultation. The predominant organism cultured was E. coli; multi-drug resistant variants were isolated in 2 patients.
Chart 2: pre treatment CSU
A repeat urine sample eight weeks after commencing weekly washouts revealed no bacterial growth in five patients, sterile leucocyturia in two and mixed growth of doubtful significance in the remaining patients. One patient failed to submit a repeat urine sample.
Out of the 13 patients complaining of recurrent symptomatic CAUTI only two have on-going infections. One patient is undergoing chemotherapy for her underlying neuroendocrine tumour. Nonetheless she describes a 50% reduction in the number of UTIs since commencing washouts over a six-month period.
The other patient stopped washouts after getting a further severe UTI within 4 weeks. His urine sample at the time of hospital admission revealed a mixed growth of coliforms, comparable to that pre treatment.
All patients struggling with recurrent catheter blockages report a notable improvement with catheter changes from initially one to two weekly now being carried every four to 10 weeks.
A total of three patients discontinued the use of MICRODOX despite clinical efficacy, two because of product cost, one because of reported discomfort on installation. Of note, two complained of increased catheter blockage again since stopping irrigation.
The washouts are generally well tolerated with only two patients describing a burning sensation on installation and one reporting haematuria. This may be an unrelated finding and is currently under investigation.
Interpretation of results
We have observed an overall positive effect of bladder irrigation with MICRODOX solution for both reduction of recurrent CAUTI including those with multi-drug resistant colonising strains, and increased catheter longevity.
The aetiology of CAUTI in this vulnerable group of patients is multifactorial and credit cannot be given to the use of MICRODOX washouts alone in the scope of this review. However, all patients are long-term patients of our unit and have been thoroughly investigated and treated prior to commencing these installations as a self-funded and currently not publicly available adjunct to treatment.
Unfortunately lack of funding is the largest barrier to recruiting larger patients numbers, but increasing numbers of documented positive outcomes may change this going forward.