EC Gynaecology

Research Article Volume 13 Issue 2 - 2024

Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women with Acute Cystitis

Khodyreva LA1,2, Bernikov AN1,3, Kupriyanov YA1,2,3, Arefieva OA1,2,3, Orešnik M4* and Pushkar DY1,2,3

1Moscow Urological Center on the Basis of Botkin Hospital, Russia

2Research Institute of the Moscow Department of Health, Russia

3Federal State Budgetary Educational Institution of Higher Education “Russian University of Medicine” of the Ministry of Health of the Russian Federation, Russia

4PharmaLinea Ltd., Slovenia

*Corresponding Author: Orešnik M, Science and Research Director, PharmaLinea Ltd., Ljubljana, Slovenia.
Received: December 22, 2023; Published: January 11, 2024

Uncomplicated lower urinary tract infections (LUTI) are one of the most common infections in adult women. LUTI are often relapsing and consequently significantly affect the quality of life of affected population. Antibiotics are treatment of choice in the case of LUTI occurrence, but especially due to the increasing pathogen resistance alternative approaches are being researched. We aimed to evaluate the efficacy and safety of the Qcran®, D-mannose and vitamin D3 based food supplement in women with acute cystitis and its effect on the recurrence of LUTI. We screened 111 female patients aged 18 - 80 years, with active acute cystitis, that was confirmed by a positive bacteriological urine test. Eligible participants were randomized into 2 parallel groups, in a 1:1 ratio, to receive either standard single dose of antibiotic therapy or antibiotic therapy and food supplement. After 12 weeks, proportion of patient without cystitis relapse in the group with scheduled supplementation was significantly higher than in control versus 19,2% (p < 0.0001). By the end of the trial the difference in the mean recurrence of the disease was 0,78 ± 0,63 and reached statistical significance (p < 0.0001). According to ACSS QoL subscale and VAS QoL scale, quality of life significantly improved in the supplement group at all time points, as compared to control group.

Uronext® present a new, effective and well tolerated approach to improved management of LUTI in adult women.

 Keywords: Cystitis; Women; Cranberry; D-Mannose; Supplement; Antibiotic; Recurrence; Quality of Life

  1. Scholes D., et al. “Risk factors for recurrent urinary tract infection in young women”. The Journal of Infectious Diseases4 (2000): 1177-1182.
  2. Foxman B. “Recurring urinary tract infection: incidence and risk factors”. American Journal of Public Health3 (1990): 331-333.
  3. Foxman Betsy. “Urinary tract infection syndromes: occurrence, recurrence, bacteriology, risk factors, and disease burden”. Infectious Disease Clinics of North America1 (2014): 1-13.
  4. Eriksson Irene., et al. “Do urinary tract infections affect morale among very old women?” Health and Quality of Life Outcomes 1 (2010): 73.
  5. Foxman B., et al. “Risk factors for second urinary tract infection among college women”. American Journal of Epidemiology12 (2000): 1194-1205.
  6. Abrahamian FM., et al. “The association of antimicrobial resistance with cure and quality of life among women with acute uncomplicated cystitis”. Infection6 (2011): 507-514.
  7. Hannan Thomas J., et al. “Host-pathogen checkpoints and population bottlenecks in persistent and intracellular uropathogenic Escherichia coli bladder infection”. FEMS Microbiology Reviews3 (2012): 616-648.
  8. Glover Matthew., et al. “Recurrent urinary tract infections in healthy and nonpregnant women”. Urological Science 1 (2014): 1-8.
  9. Stamey TA and C C Sexton. “The role of vaginal colonization with Enterobacteriaceae in recurrent urinary infections”. The Journal of Urology2 (1975): 214-217.
  10. Hooton Thomas M., et al. “Voided midstream urine culture and acute cystitis in premenopausal women”. The New England Journal of Medicine20 (2013): 1883-1891.
  11. Renard Julien., et al. “Recurrent lower urinary tract infections have a detrimental effect on patient quality of life: a prospective, observational study”. Infectious Diseases and Therapy1 (2014): 125-135.
  12. Sihra Néha., et al. “Nonantibiotic prevention and management of recurrent urinary tract infection”. Nature Reviews. Urology12 (2018): 750-776.
  13. Castelló T., et al. “The possible value of ascorbic acid as a prophylactic agent for urinary tract infection”. Spinal Cord10 (1996): 592-593.
  14. Ochoa-Brust Gonzalo Javier., et al. “Daily intake of 100 mg ascorbic acid as urinary tract infection prophylactic agent during pregnancy”. Acta Obstetricia Et Gynecologica Scandinavica7 (2007): 783-787.
  15. Falagas Matthew E., et al. “Probiotics for prevention of recurrent urinary tract infections in women: a review of the evidence from microbiological and clinical studies”. Drugs9 (2006): 1253-1261.
  16. Baerheim A., et al. “Vaginal application of lactobacilli in the prophylaxis of recurrent lower urinary tract infection in women”. Scandinavian Journal of Primary Health Care4 (1994): 239-243.
  17. Beerepoot MAJ., et al. “Nonantibiotic prophylaxis for recurrent urinary tract infections: a systematic review and meta-analysis of randomized controlled trials”. The Journal of Urology6 (2013): 1981-1989.
  18. Stapleton Ann E., et al. “Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection”. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America10 (2011): 1212-1217.
  19. Naber Kurt G., et al. “Immunoactive prophylaxis of recurrent urinary tract infections: a meta-analysis”. International Journal of Antimicrobial Agents2 (2009): 111-119.
  20. Blumberg Jeffrey B., et al. “Cranberries and their bioactive constituents in human health”. Advances in Nutrition (Bethesda, Md.) 6 (2013): 618-632.
  21. Hisano Marcelo., et al. “Cranberries and lower urinary tract infection prevention”. Clinics (Sao Paulo, Brazil)6 (2012): 661-668.
  22. Kranjčec Bojana., et al. “D-mannose powder for prophylaxis of recurrent urinary tract infections in women: a randomized clinical trial”. World Journal of Urology1 (2014): 79-84.
  23. De Nunzio Cosimo., et al. “Role of D-mannose in the prevention of recurrent uncomplicated cystitis: state of the art and future perspectives”. Antibiotics (Basel, Switzerland)4 (2021): 373.
  24. Parazzini Fabio., et al. “Systematic review of the effect of D-mannose with or without other drugs in the treatment of symptoms of urinary tract infections/cystitis (Review)”. Biomedical Reports2 (2022): 69.
  25. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). “Scientific Opinion on the substantiation of health claims related to vitamin D and normal function of the immune system and inflammatory response (ID 154, 159), maintenance of normal muscle function (ID 155) and maintenance of normal cardiovascular function (ID 159) pursuant to Article 13(1) of Regulation (EC) No 1924/2006”. EFSA Journal2 (2010): 1468.
  26. Hertting Olof., et al. “Vitamin D induction of the human antimicrobial Peptide cathelicidin in the urinary bladder”. PloS one12 (2010): e15580.
  27. Mohanty Soumitra., et al. “Vitamin D strengthens the bladder epithelial barrier by inducing tight junction proteins during coli urinary tract infection”. Cell and Tissue Research 380.3 (2020): 669-673.
  28. Alidjanov Jakhongir F., et al. “Reevaluation of the acute cystitis symptom score, a self-reporting questionnaire. Part I. development, diagnosis and differential diagnosis”. Antibiotics (Basel Switzerland)1 (2018): 6.
  29. Alidjanov Jakhongir F., et al. “New self-reporting questionnaire to assess urinary tract infections and differential diagnosis: acute cystitis symptom score”. Urologia Internationalis2 (2014): 230-236.
  30. Wagenlehner Florian., et al. “Social and economic burden of recurrent urinary tract infections and quality of life: a patient web-based study (GESPRIT)”. Expert Review of Pharmacoeconomics and Outcomes Research1 (2018): 107-117.
  31. Bonkat Gernot., et al. "EAU Guidelines on Urological Infections 2023”. European Association of Urology (2023).
  32. Fajfr Miroslav., et al. “Effective treatment for uncomplicated urinary tract infections with oral fosfomycin, single center four year retrospective study”. Antibiotics (Basel Switzerland)8 (2020): 511.
  33. Burton Claire S., et al. “Female lower urinary tract symptom prevention and treatment strategies on social media: mixed correlation with evidence”. Urology 150 (2021): 139-145.
  34. Williams Gabrielle., et al. "Cranberries for preventing urinary tract infections”. Cochrane Database of Systematic Reviews 11 (2023): CD001321.
  35. Rădulescu D David., et al. "Combination of cranberry extract and D-mannose - possible enhancer of uropathogen sensitivity to antibiotics in acute therapy of urinary tract infections: Results of a pilot study". Experimental and Therapeutic Medicine4 (2020): 3399-3406.
  36. Faggian Marta., et al. "Characterization of PACs profile and bioactivity of a novel nutraceutical combining cranberry extracts with different PAC-A oligomers, D-mannose and ascorbic acid: An in vivo/ex vivo evaluation of dual mechanism of action on intestinal barrier and urinary epithelium”. Food Research International 149 (2021): 110649.
  37. Murina Filippo., et al. “Efficacy of an orally administered combination of Lactobacillus paracasei LC11, cranberry and D-mannose for the prevention of uncomplicated, recurrent urinary tract infections in women”. Urologia Journal1 (2021): 64-68.

Orešnik M., et al. "Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women with Acute Cystitis". EC Gynaecology 13.2 (2024): 01-13.