In:
Urologia Internationalis, S. Karger AG, Vol. 102, No. 4 ( 2019), p. 468-475
Abstract:
〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Patients and Methods: 〈 /i 〉 〈 /b 〉 In this multicentre, randomised, parallel group, double-blind, phase IV study, xyloglucan + gelose ( 〈 i 〉 n 〈 /i 〉 = 20) or placebo ( 〈 i 〉 n 〈 /i 〉 = 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. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 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 ≥10 〈 sup 〉 3 〈 /sup 〉 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 〈 i 〉 p 〈 /i 〉 & #x3c; 0.05), with symptom resolution in all patients by Day 90. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 The xyloglucan + gelose medical device was safe, well tolerated, and it reduced bacteriological and symptomatic parameters in adults with uncomplicated UTI.
Type of Medium:
Online Resource
ISSN:
0042-1138
,
1423-0399
Language:
English
Publisher:
S. Karger AG
Publication Date:
2019
detail.hit.zdb_id:
1464417-4
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