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

Abstract

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).

Xyloglucan, a Plant Polymer with Barrier Protective Properties over the Mucous Membranes: An Overview

“…An improvement in all the symptoms in the group treated with the medical device was observed after treatment completion. The treatment was safe and well tolerated [ 26 ].…”

“…These favourable in vitro results have been correlated with favourable results in clinical trials in patients with gastroenteritis [ 23 , 24 ], nasal disorders [ 15 ] and dry eye syndrome [ 28 ]. Similar mucosal protectors containing reticulated proteins have also proved to be useful for the treatment of IBS [ 48 ] and UTIs [ 26 , 27 ]. Based on the similar film-forming protective effects between xyloglucan and other mucosal protectors, medical devices containing xyloglucan can also be expected to have a role in IBS and UTIs, although randomized clinical trials should be performed to demonstrate this.…”

“…We present the results of in vitro studies in models of intestinal and nasal mucosa and conjunctival cells [ 1 , 16 , 17 , 22 ] and in vivo models of intestinal inflammation and diarrhoea, demonstrating its barrier properties against bacterial adhesion and invasion and pro-inflammatory compounds, and the results of clinical studies in which the mucosal protectors have demonstrated their protective effect in patients with gastrointestinal disorders (mainly diarrhoea), urinary tract infections, nasal respiratory diseases and dry eye syndrome [ 15 , 23 , 24 , 25 , 26 , 27 , 28 ]. Since medical devices containing mucosal protectors are a new strategy for the management of these diseases, we discuss the data published to date and the issues that deserve further research.…”

Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study

“…Treatment of IBS patients with a similar mucosal protector containing film-forming reticulated proteins plus oligo-and polysaccharides relieved abdominal pain and flatulence (22). In placebo-controlled trials, reticulated proteins were also effective in treating urinary tract infections (23,24). In a pilot study, APT198K (xyloglucan plus heat-killed Lactobacillus reuteri SGL01 and Bifidobacterium brevis SGB01) was superior to a lactase dietary supplement in reducing the mean duration of crying per episode in 46 children with infantile colic (25).…”

Evaluation of Reticulated Gelatin-Hibiscus-Propolis Against Intestinal Commensal Species Commonly Associated with Urinary Tract Infections

“…Reticulated gelatin hibiscus and propolis (RGHP) is an oral class III medical device recently approved in the EU to control and prevent UTIs [15]. RGHP contains a combination of natural products: reticulated gelatin (RG), Hibiscus sabdariffa and propolis.…”