Recurring Cystitis: Vaccine Effectiveness Questioned
- Where do we stand now with vaccines against recurrent urinary infections, a topic that has been around for fifty years?
- A meta-analysis published in 2020 (1) had nevertheless led the European Association of Urology (EAU) to consider, in its 2024 recommendations, the effectiveness of these immuno-active products as...
- Actually, these two main meta-analyses chose different methodological approaches.
Where do we stand now with vaccines against recurrent urinary infections, a topic that has been around for fifty years? “As an infectious disease specialist, the desire to use option strategies to antibiotics in prophylaxis, especially in a pathology as common as recurrent cystitis, is very strong,” recognizes Dr.Ruxandra Calin (Infectious and Tropical Diseases Department, Tenon Hospital, Paris). “However, our hope is tempered, first because none of the current products (see boxed text) are marketed in France, but especially by the questionable quality of the available evidence.”
About-face in recommendations
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A meta-analysis published in 2020 (1) had nevertheless led the European Association of Urology (EAU) to consider, in its 2024 recommendations, the effectiveness of these immuno-active products as demonstrated with a level of evidence 1a and to recommend them for the prevention of recurrent cystitis in women concerned. But another meta-analysis published in 2024 (2) led the learned society to revise its copy. And in its 2025 recommendations, the EAU now estimates that the evidence is limited.Why such a gap?
Actually, these two main meta-analyses chose different methodological approaches. “While, in the 2020 one, clinical trials and cohort studies are analyzed together,” explains Dr. Calin, “in the 2024 one, RCTs and cohorts are evaluated separately.” Another difference: the number of studies included, slightly lower in the 2024 meta-analysis (14 including 11 RCTs versus 17 including 12 RCTs), some studies from the 1980s having been excluded for methodological weakness while others, published more recently (until 2023), were integrated. With, consequently, a benefit considered moderate (RR 1.52).
A poorly documented mechanism of action
If the clinical data are fragile, what is the contribution of basic research? At this stage, there are very few answers to the mode of action of these products.
A research team from the Pasteur Institute-Université paris Cité (3) used a modè
Immunotherapy for Recurrent Cystitis: Current Status
Immunotherapy is being explored as a potential treatment for recurrent cystitis, positioned between hygiene measures and antibiotic prophylaxis, but currently limited to rigorous clinical trials. Professor Albert Sotto of the University Hospital of Nîmes (CHU de Nîmes) acknowledges this role, emphasizing the need for well-defined clinical trials to assess efficacy.
What is Recurrent cystitis?
Recurrent cystitis is defined as frequent urinary tract infections (UTIs), specifically cystitis (bladder infection).The exact definition used in clinical trials is crucial for accurate assessment of treatment effectiveness. Currently, there is no universally agreed-upon definition, which complicates research efforts.
Available Immunotherapy Products
Several immuno-active prophylactic treatments have been developed, all utilizing Escherichia coli in various forms. These strategies aim to modulate the immune system to prevent recurrent infections.
- OM-89 (Uro-Vaxom): An oral capsule taken daily for 90 days, containing lysates from 18 strains of uropathogenic E. coli.
- Solco-Urovac: administered intravaginally as ovules on days 1, 3, and 5, with potential for a booster. It’s a mixture of heat-killed whole bacteria.
- MV140 (Uromune): A sublingual spray, two sprays daily for three months, also containing heat-killed bacteria.
- StroVac: An injectable form of Solco-Urovac, administered as three intramuscular injections two weeks apart.
- ExPEC4V: Currently only in clinical trials, this is an intramuscular injection composed of lipopolysaccharides from E. coli.
Recent Research and Clinical Trials
Research continues to evaluate the effectiveness of these immunotherapies. A 2020 study by Prattley S et al. in european Urology Focus [European Urology focus] examined the potential of these approaches. More recent research in 2024 by Mak Q et al., also published in European Urology Focus [European Urology Focus], builds upon these findings. Preliminary data from a 2025 study by Canton T et al. available on biorxiv [BioRxiv] suggests ongoing investigation into novel immunotherapy strategies.Earlier work by Bosch A et al. in 1988, published in Immunopharmacol Immunotoxicol [Immunopharmacology and Immunotoxicology], laid some of the groundwork for these current studies.
Note: As of January 22, 2026, these immunotherapies remain primarily within the scope of clinical trials and are not yet standard treatment for recurrent cystitis.