BACKGROUND AND PURPOSE:

• Recurrent UTIs: Defined ≥3 episodes in 1 year or ≥2 infections in 6 months
• Lorenzo-Gómez et al. (NEJM Evidence, 2022) assessed whether a 3- or 6-month treatment course of a sublingual preparation of inactivated bacteria reduced the risk of UTIs in women with recurrent UTI

METHODS:

• Multicenter, randomized, double-blind, placebo-controlled, parallel-group 1-year trial
• Participants
  • Women 18 to 75 years
  • Diagnosed with recurrent UTI
• Intervention
  • MV140 for 3 months
  • MV140 for 6 months
  • Placebo for 6 months
• Study design
  • Inclusion criteria: ≥5 uncomplicated cystitis episodes in the previous year
    • Based on previous experience with patients presenting for treatment, including previous studies and those most likely to enroll
  • MV140
    • Sublingual preparation of whole-cell heat-inactivated bacteria
    • Self-administered daily sublingually by spraying two sprays of 100 μl each under the tongue
  • Additional medication, including antibiotics for managing UTI, were permitted
  • Participants were randomized to an intervention 1:1:1
  • Study period: 6 months intervention with additional 6 months follow-up        
• Primary outcome
  • Number of UTIs in the 9-month study period after initial 3 months of intervention
• Secondary outcomes
  • Percentage of women who were UTI free over the study period
  • Time to UTI onset
  • Health-related quality of life

RESULTS:

• 3-month MV140: 77 women | 6-month MV140: 75 | Placebo: 77
• Participants in both MV140 groups experienced fewer UTI episodes than the placebo group (P<0.001)
  • Both MV140 groups: median 0.0 (IQR, 0.0 to 1.0) episodes
  • Placebo: 3.0 (IQR, 0.5 to 6.0) episodes
• Free from UTI at end of study period
  • Placebo: 25% (95% CI, 15 to 35%)
  • 3-month MV140: 56% (95% CI, 44 to 67%)
  • 6-month MV140: 58% (95% CI, 44 to 67%)
• Hazard ratios (HR) for UTI vs placebo
  • 3-month MV140: 0.36 (95% CI, 0.23 to 0.56)
  • 6-month MV140: 0.33 (95% CI, 0.21 to 0.54)
• Adverse events
  • Total of 205 events in 101 participants
    • Placebo: 81 events
    • 3-month MV140: 76 events
    • 6-month MV140: 48 events
  • Most common AEs (≥5% of participants)
    • Chest infection | Candidiasis | Vaginitis

CONCLUSION:

• In this clinical trial, MV140 was effective at reducing recurrent UTI in women
• There did not appear to be a difference between a 3- or 6-month course of therapy
• There were no significant adverse events
• It is not well understood how the therapy works but MV140 appears to induce an adaptive antibody response
• The authors state

…our current trial confirms that MV140 conferred durable protection for at least 1 year

The longer clinical benefits of MV140 once treatment is completed differ from management of recurrent UTI with antibiotic prophylaxis, which shows a rapid lack of efficacy following discontinuation as well as numerous side effects

Learn More – Primary Sources:

Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections

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