Hypothesis / aims of study
Recurrent urinary tract infections (rUTIs) remain a major problem in patients with neuropathic bladder (NB), contributing to morbidity, antibiotic resistance, and diminished quality of life. MV140, a sublingual bacterial immune-modulator containing inactivated Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, and Proteus vulgaris, has shown benefit in idiopathic rUTIs. A nine-year follow-up study demonstrated significant and sustained benefit with MV140; however, there is limited evidence regarding its role in managing patients with NB or at a higher dose. This study prospectively evaluates the effectiveness of double-dose MV140 in this cohort.
Study design, materials and methods
A prospective review was conducted of 14 patients (3 male, 11 female; mean age 46 years, range 24–72) with NB of mixed aetiologies—spinal cord injury (n=6), multiple sclerosis (n=1), prior incontinence surgery (n=1), Fowler’s syndrome (n=1), and advanced insulin-dependent diabetes mellitus (IDDM) (n=1)—treated with double-dose MV140, defined as two sublingual puffs administered twice daily. Thirteen patients (93%) performed intermittent self-catheterisation (ISC) and one voided spontaneously. 3 patients were on concurrent intravesical gentamicin and 1 on iALURIL instillations, which continued during the induction and follow up period. Mean follow-up was 12 months. Baseline infection frequency, urine culture results, and post-treatment outcomes were analysed. The primary endpoint was reduction in infection frequency; secondary endpoints included UTI-free status, infection severity, and bacteriological clearance.
Results
Pre MV140, 5 patient’s experienced monthly infections and 9 had recurrent infections despite prophylaxis. Cultures were positive for E. coli, Klebsiella species, and mixed flora. After MV140, 9/14 (64%) remained UTI-free and 5/14 (36%) had a single mild breakthrough episode. Median infection frequency decreased from five to two per year. Post-treatment cultures were negative in most cases, with two showing asymptomatic bacteriuria when tested at the end of the three-month course. All patients self-administered the twice-daily medication without difficulty, and no adverse reactions were recorded.
Interpretation of results
Double-dose MV140 was associated with a substantial and clinically meaningful reduction in infection burden in patients with neuropathic bladder, with nearly two-thirds remaining completely UTI-free and the remainder experiencing only isolated, less severe breakthrough infections. The marked reduction in annual infection frequency, alongside predominantly negative post-treatment cultures, suggests effective immunomodulatory control of recurrent infection even in a high-risk cohort predominantly performing intermittent self-catheterisation. These findings indicate that intensified MV140 dosing may provide durable prophylactic benefit in neuropathic bladder populations where conventional strategies often fail, supporting its role as a safe and promising non-antibiotic therapeutic option.