Evaluation of the Efficacy and Safety of MV140

Prospective Randomized, Double-blind, Parallel-controlled Versus Placebo in a Polyvalent Sublingual Bacterial Vaccine to 3 Months and 6 Months in Women With RUTI for the Immunomodulatory Efficacy Evaluation, Safety and Clinical Impact

The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo group.

Double blind parallel placebo controlled study. The subjects will receive medication during three or six months and will be followed up during another twelve months.

Inclusion Criteria:

• Women who gave their informed consent.
• Age between 18 and 75 years.
• Must be able to meet the dosage regimen.
• Subjects who had had at least 5 episodes of cystitis in the last 12 months.
• Subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
• Subjects who were free of urinary tract infections at the time of inclusion in the study.

Exclusion Criteria:

• Had not given their informed consent.
• Age was not within the established age range.
• Could not offer cooperation and/or had severe psychiatric disorders.
• Presented a pathologic post-micturition residue.
• Presented moderate to severe incontinence.
• Presented genital tumours.
• Presented Urinary tract tumours.
• Presented lithiasis.
• Presented alterations in the immune system.
• Presented complicated UTIs.