Xyloglucan + Gelose Combination versus Placebo as Adjuvant Therapy to First-Line Antimicrobials for Uncomplicated Urinary Tract Infection in Adults
| Autor: | Radu Cristian Costache, Bogdan Novac, Antoine Edu, Dorin Nicolae Agapie, Tiberiu Razvan Bardan |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Urology Urinary system media_common.quotation_subject 030232 urology & nephrology Urination Urinary incontinence Placebo Gastroenterology Drug Administration Schedule 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Anti-Infective Agents Double-Blind Method Ciprofloxacin Recurrence Internal medicine medicine Adjuvant therapy Humans Adverse effect Glucans media_common Aged Mucous Membrane business.industry Middle Aged Xyloglucan Treatment Outcome chemistry Chemotherapy Adjuvant 030220 oncology & carcinogenesis Urinary Tract Infections Female Xylans Patient Safety medicine.symptom business medicine.drug |
| Zdroj: | Urologia internationalis. 102(4) |
| ISSN: | 1423-0399 |
| Popis: | Background: A medical device containing xyloglucan-gelose-hibiscus-propolis (referred to hereafter as xyloglucan + gelose) acts as a mucosal barrier protector and urinary acidifier. The safety and efficacy of this device were investigated as adjuvant therapy to first-line antimicrobials for treatment of uncomplicated urinary tract infection (UTI) in adults. Patients and Methods: In this multicentre, randomised, parallel group, double-blind, phase IV study, xyloglucan + gelose (n = 20) or placebo (n = 20) were administered orally in combination with an antimicrobial agent (e.g., ciprofloxacin) for 5 days, then alone for 5 days, then beginning on Day 30 of the study for 15 days per month for 2 months. Results: Frequency of adverse events (AEs) was 5 and 45% in the xyloglucan + gelose and placebo groups respectively. All AEs were unrelated to study products. Xyloglucan + gelose reduced uroculture positivity (defined as a bacterial count ≥103 CFU/mL) from 100% of patients at baseline to 0% at Day 11, with recurrence in 3 patients (15%) by Day 76. Corresponding results with placebo were 100% uroculture positive patients at baseline reduced to 45% at Day 11, with recurrence in 14 patients (70%) by Day 76. Xyloglucan + gelose significantly reduced the frequency of urinary incontinence and urgency of micturition compared with placebo (both p < 0.05), with symptom resolution in all patients by Day 90. Conclusions: The xyloglucan + gelose medical device was safe, well tolerated, and it reduced bacteriological and symptomatic parameters in adults with uncomplicated UTI. |
| Databáze: | OpenAIRE |
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