Phytotherapy (BNO 1045) of Acute Lower Uncomplicated Urinary Tract Infection in Women Normalizes Local Host Responses

Urol Int. 2023;107(8):778-784. doi: 10.1159/000531206. Epub 2023 Aug 4.

Abstract

Introduction: Acute lower uncomplicated urinary tract infection (uUTI) affects a large proportion of women. Increased antimicrobial resistance has created an urgent need for novel therapeutics and the phytotherapeutic drug BNO 1045 (Canephron® N) has previously been shown to be noninferior to standard antimicrobial stewardship. This sub-analysis from a randomized, double-blind, controlled phase III noninferiority clinical trial using BNO 1045 versus fosfomycin to treat uUTI aimed to determine how urine cytokine levels are altered by the two different treatments.

Methods: Urine samples from a predefined subset of women diagnosed with uUTI (18-70 years) and treated with BNO 1045 (n = 58) or fosfomycin (n = 69) were analyzed for urine levels of IL-6 and IL-8, using analyte-to-creatinine ratios.

Results: BNO 1045 treatment showed similar effects to fosfomycin treatment in reducing both urine IL-6 and IL-8 levels. Mean IL-6 and IL-8 levels were markedly reduced in all patients regardless of treatment. BNO 1045 treatment decreased urine IL-8 significantly (p = 0.0142) and showed a trend toward reduction of urine IL-6 (p = 0.0551). Fosfomycin treatment reduced both IL-6 and IL-8 levels significantly (p = 0.0038, <0.0001 respectively).

Conclusion: BNO 1045 is, in addition to reducing symptoms, comparable to fosfomycin treatment in reducing the local inflammatory response associated with uUTI.

Keywords: BNO 1045; Phytotherapy; Uncomplicated urinary tract infection; Urine cytokines.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III

MeSH terms

  • Anti-Bacterial Agents / therapeutic use
  • Female
  • Fosfomycin* / therapeutic use
  • Humans
  • Interleukin-6
  • Interleukin-8
  • Phytotherapy
  • Urinary Tract Infections* / drug therapy

Substances

  • canephron N
  • Fosfomycin
  • Interleukin-8
  • Interleukin-6
  • Anti-Bacterial Agents

Grants and funding

This clinical trial was sponsored by Bionorica SE, Germany. No additional funding is applicable.