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Grand Rounds

RCT Results: A New Sublingual Bacterial Treatment for Recurrent UTI

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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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Related ObG Topics:

Nitrofurantoin or Fosfomycin to treat an uncomplicated UTI?
Do Cranberries Decrease Risk of UTIs?
Can Drinking More Water Prevent Recurrent Urinary Tract Infections?

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