Evidence map›Paper›PMID 26090341›Full record

Trial reportFrontiers in cellular and infection microbiology2015

Comparison of sublingual therapeutic vaccine with antibiotics for the prophylaxis of recurrent urinary tract infections.

María F Lorenzo-Gómez, Bárbara Padilla-Fernández, María B García-Cenador, Álvaro J Virseda-Rodríguez, Isidoro Martín-García, Alfonso Sánchez-Escudero, Manuel J Vicente-Arroyo, José A Mirón-Canelo

2 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Frontiers in cellular and infection microbiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02543827 phase3completednot on this map

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

TypeinterventionalSponsorInmunotek S.L.Ran2015 to 2020Enrolled240ConditionsUrinary Tract Infection BacterialArmsMV140, Placebo
NCT04173013 no longer availablenot on this map

Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

Typeexpanded_accessSponsorImpatients N.V. trading as myTomorrowsConditionsUrinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection, Urinary Tract Infection BacterialArmsUromune
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 73 citations in OpenAlex.

  1. Trial
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  5. Review
  6. Article
  7. Article
  8. Article
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  12. Article
  13. MV140 sublingual vaccine reduces recurrent urinary tract infection in women Results from the first North American clinical experience study.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024
    Article
  14. A Bird's-Eye View of the Pathophysiologic Role of the Human Urobiota in Health and Disease: Can We Modulate It?Pathophysiology : the official journal of the International Society for Pathophysiology · 2024
    Review
  15. Article
  16. Review
  17. Review
  18. Uropathogen and host responses in pyelonephritis.Nature reviews. Nephrology · 2023
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

María F Lorenzo-GómezIBSAL Salamanca Biomedical Research Institute Salamanca, Spain ; Department of Surgery, University of Salamanca Salamanca, Spain ; Department of Urology, University Health Complex of Salamanca Salamanca, Spain.
Bárbara Padilla-FernándezDepartment of Urology, University Hospital of the Canary Islands' Complex Tenerife, Spain.
María B García-CenadorDepartment of Urology, University Health Complex of Salamanca Salamanca, Spain.
Álvaro J Virseda-RodríguezDepartment of Surgery, University of Salamanca Salamanca, Spain ; Department of Urology, University Health Complex of Salamanca Salamanca, Spain.
Isidoro Martín-GarcíaPrimary Care Centre "Universidad Centro" Salamanca, Spain.
Alfonso Sánchez-EscuderoPrimary Care Centre "Peñaranda" Salamanca, Spain.
Manuel J Vicente-ArroyoPrimary Care Centre "Capuchinos" Salamanca, Spain.
José A Mirón-CaneloDepartment of Preventive Medicine and Public Health, University of Salamanca Salamanca, Spain.
Hospital Universitario de Canarias · ESUniversidad de Salamanca · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the clinical impact of a prophylactic treatment with sublingual immunostimulation in the prevention of recurrent urinary tract infections (rUTIs) with the use of antibiotics. MATERIAL AND

methodsRetrospective cohort study evaluating the medical records of 669 women with rUTIs; 339 had a 6-month prophylaxis with antibiotics and 360 a 3-month prophylaxis with a sublingual bacterial preparation (MV 140-Uromune®). The time frame after the prophylaxis-period until the appearance of a new infection (assessed by uroculture) was scored and followed during 1 year. The absolute risk reduction (ARR) and number needed to treat (NNT) were also calculated.

resultsAll patients treated with antibiotics experienced a new UTI during the scoring period of 12 months, being 19 days the median number of days free of UTIs (range 5-300). In the group treated with the bacterial preparation, 35 (9.7%) patients experienced an UTI in the same period. Kaplan-Meier curves comparing the accumulated survival (disease-free time) between both groups were significant different (P < 0.0001). The absolute risk reduction (ARR) was 90.28% (87.18-93.38) and the number needed to treat (NNT) 1.1 (1.1-1.1).

conclusionsThese results suggest that the treatment with this bacterial preparation significantly reduces the incidence of rUTIs, arising as an effective strategy to reduce the frequency of rUTIs. It reduces antibiotic consumption, matching the current recommendations due to the raise of antimicrobial resistance. Randomized, double-blind and placebo-controlled, clinical trials are needed to establish, more accurately, the clinical impact of this bacterial preparation in patients with rUTIs.

Indexed as

Administration, SublingualAdultAgedAnti-Bacterial AgentsChemopreventionCohort StudiesFemaleHumansMiddle AgedRandomized Controlled Trials as TopicRecurrenceRetrospective StudiesTreatment OutcomeUrinary Tract InfectionsVaccinesAnti-Bacterial AgentsVaccinesbacterial vaccinerecurrent urinary infectionsUromune (MV 140)

Identifiers

PMID26090341
PMCPMC4452880
OpenAlexW1587833172

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.