Efficacy and Safety of a Medical Device versus Placebo in the Early Treatment of Patients with Symptoms of Urinary Tract Infection: A Randomized Controlled Trial
- *Corresponding Author:
- Alejandro García-Larrosa
Department of Urology
Hospital del Mar
Passeig Marítim de la Barceloneta
25-29, 08003 Barcelona, Spain
E-mail: [email protected]
Received Date: January 14, 2016 Accepted Date: January 28, 2016 Published Date: February 05, 2015
Citation: García-Larrosa A, Alexe O (2016) Efficacy and Safety of a Medical Device versus Placebo in the Early Treatment of Patients with Symptoms of Urinary Tract Infection: A Randomized Controlled Trial. Clin Microbiol 5:233. doi: 10.4172/2327-5073.1000233
Copyright: © 2016 García-Larrosa A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: The objective of the study was to analyze the efficacy and safety of a medical device containing reticulated gelatin with hibiscus and propolis (RGHP) in the early treatment of patients with symptoms of urinary tract infection (UTI).
Methods: A double-blind, placebo-controlled trial was carried out in 60 patients who were randomized (1:1) to RGHP or placebo twice daily for 5 days. Follow-up was 11 days.
Results: The risk ratio of patients who needed antibiotic treatment was lower in the RGHP group (RR, 0.3; 95% CI, 0.09 to 0.98). RGHP provided greater symptom relief than placebo (mean adjusted change in the global symptom score from baseline: -5.27 vs. 0.40; p<0.001). Adverse events were reported by 6.67% and 3.33% of patients (RGHP and placebo, respectively, p=0.5).
Conclusions: RGHP was more effective than placebo in improving UTI symptoms and reduced the need for rescue antibiotic treatment.