PMID- 30889607
OWN - NLM
STAT- MEDLINE
DCOM- 20200128
LR  - 20200128
IS  - 1423-0399 (Electronic)
IS  - 0042-1138 (Linking)
VI  - 102
IP  - 4
DP  - 2019
TI  - Xyloglucan + Gelose Combination versus Placebo as Adjuvant Therapy to First-Line 
      Antimicrobials for Uncomplicated Urinary Tract Infection in Adults.
PG  - 468-475
LID - 10.1159/000497106 [doi]
AB  - 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.
CI  - (c) 2019 S. Karger AG, Basel.
FAU - Costache, Radu Cristian
AU  - Costache RC
AD  - Department of Urology, "Dr. C. I. Parhon" Clinical Hospital, Iasi, Romania.
FAU - Novac, Bogdan
AU  - Novac B
AD  - Department of Urology, "Dr. C. I. Parhon" Clinical Hospital, Iasi, Romania.
FAU - Bardan, Tiberiu Razvan
AU  - Bardan TR
AD  - Department of Urology, "Pius Brinzeu" County Emergency Clinical Hospital, 
      Timisoara, Romania.
FAU - Agapie, Dorin Nicolae
AU  - Agapie DN
AD  - Department of General Surgery, City Emergency Clinical Hospital, Timisoara, 
      Romania.
FAU - Edu, Antoine
AU  - Edu A
AD  - Department of Obstetrics and Gynaecology, "Nicolae Malaxa" Clinical Hospital, 
      Bucharest, Romania, Simonaedu98@yahoo.com.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20190319
PL  - Switzerland
TA  - Urol Int
JT  - Urologia internationalis
JID - 0417373
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Glucans)
RN  - 0 (Xylans)
RN  - 37294-28-3 (xyloglucan)
RN  - 5E8K9I0O4U (Ciprofloxacin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Infective Agents/*administration & dosage
MH  - Chemotherapy, Adjuvant/*methods
MH  - Ciprofloxacin/administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glucans/*administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mucous Membrane/drug effects
MH  - Patient Safety
MH  - Recurrence
MH  - Treatment Outcome
MH  - Urinary Tract Infections/*drug therapy
MH  - Urination/drug effects
MH  - Xylans/*administration & dosage
MH  - Young Adult
OTO - NOTNLM
OT  - Adjuvant therapy
OT  - First-line antimicrobials
OT  - Gelose
OT  - Urinary tract infection
OT  - Xyloglucan
EDAT- 2019/03/20 06:00
MHDA- 2020/01/29 06:00
CRDT- 2019/03/20 06:00
PHST- 2018/11/15 00:00 [received]
PHST- 2019/01/21 00:00 [accepted]
PHST- 2019/03/20 06:00 [pubmed]
PHST- 2020/01/29 06:00 [medline]
PHST- 2019/03/20 06:00 [entrez]
AID - 000497106 [pii]
AID - 10.1159/000497106 [doi]
PST - ppublish
SO  - Urol Int. 2019;102(4):468-475. doi: 10.1159/000497106. Epub 2019 Mar 19.