Clinical trials
Interstitial cystitis
Urinary tract infections
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
24 06 2022
24 06 2022
Historique:
entrez:
24
6
2022
pubmed:
25
6
2022
medline:
29
6
2022
Statut:
epublish
Résumé
Bearberry ( The objective of the study is to assess the safety and non-inferiority of bearberry as an alternative therapy in the treatment of acute uncomplicated cystitis in comparison with standard antibiotic therapy (fosfomycin). This is a randomised controlled double-blinded multicentre trial. Eligible patients will be premenopausal women with a sum score of ≥6 for the typical acute uncomplicated cystitis symptoms (frequency, urgency, painful urination, incomplete emptying, suprapubic pain and visible haematuria) reported on the Acute Cystitis Symptom Score (ACSS) typical domain and pyuria. Patients will be randomly assigned to receive 3 g single dose of fosfomycin powder and two placebo tablets three times a day for 7 days or B a single dose of placebo powder and two tablets containing a dry extract of Uvae ursi folium. At least 504 patients (allocated as 1:1) will need to be enrolled to access non-inferiority with a non-inferiority limit of 14% for the primary endpoint.Improvement of symptoms of uncomplicated cystitis (based on the ACSS score) at day 7 is defined as the primary endpoint, whereas several secondary endpoints such as the number and ratio of patients with bacteriuria at day 7, frequency and severity of side effects; recurrence of urinary tract infection, concurrent use of other over the counter (OTC) medications and food supplements will be determined to elucidate more detailed differences between the groups. The number of recurrences and medications taken for treatment will be monitored for a follow-up period of 90 days (80-100 days). This study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/4225-1/2021/EKU). The results will be disseminated by publication of peer-reviewed manuscripts. NCT05055544.
Sections du résumé
BACKGROUND
Bearberry (
OBJECTIVE
The objective of the study is to assess the safety and non-inferiority of bearberry as an alternative therapy in the treatment of acute uncomplicated cystitis in comparison with standard antibiotic therapy (fosfomycin).
METHODS AND ANALYSIS
This is a randomised controlled double-blinded multicentre trial. Eligible patients will be premenopausal women with a sum score of ≥6 for the typical acute uncomplicated cystitis symptoms (frequency, urgency, painful urination, incomplete emptying, suprapubic pain and visible haematuria) reported on the Acute Cystitis Symptom Score (ACSS) typical domain and pyuria. Patients will be randomly assigned to receive 3 g single dose of fosfomycin powder and two placebo tablets three times a day for 7 days or B a single dose of placebo powder and two tablets containing a dry extract of Uvae ursi folium. At least 504 patients (allocated as 1:1) will need to be enrolled to access non-inferiority with a non-inferiority limit of 14% for the primary endpoint.Improvement of symptoms of uncomplicated cystitis (based on the ACSS score) at day 7 is defined as the primary endpoint, whereas several secondary endpoints such as the number and ratio of patients with bacteriuria at day 7, frequency and severity of side effects; recurrence of urinary tract infection, concurrent use of other over the counter (OTC) medications and food supplements will be determined to elucidate more detailed differences between the groups. The number of recurrences and medications taken for treatment will be monitored for a follow-up period of 90 days (80-100 days).
ETHICS AND DISSEMINATION
This study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/4225-1/2021/EKU). The results will be disseminated by publication of peer-reviewed manuscripts.
TRIAL REGISTRATION NUMBER
NCT05055544.
Identifiants
pubmed: 35750460
pii: bmjopen-2021-057982
doi: 10.1136/bmjopen-2021-057982
pmc: PMC9234905
doi:
Substances chimiques
Anti-Bacterial Agents
0
Powders
0
Tablets
0
Fosfomycin
2N81MY12TE
Banques de données
ClinicalTrials.gov
['NCT05055544']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e057982Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
J Antimicrob Chemother. 2015 Sep;70(9):2456-64
pubmed: 26066581
Cent European J Urol. 2018;71(1):134-141
pubmed: 29732220
J Ethnopharmacol. 1986 Mar;15(3):231-59
pubmed: 3724205
Drugs. 2013 Nov;73(17):1951-66
pubmed: 24202878
J Glob Antimicrob Resist. 2020 Jun;21:414-416
pubmed: 32061811
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
Aust Prescr. 2019 Feb;42(1):14-19
pubmed: 30765904
Urologe A. 2017 Jun;56(6):746-758
pubmed: 28455578
Pharm World Sci. 1993 Dec 17;15(6):257-62
pubmed: 8298585
World J Urol. 2020 Aug;38(8):1977-1988
pubmed: 31549179
Int J Antimicrob Agents. 1998 Apr;10(1):39-47
pubmed: 9624542
BMC Complement Altern Med. 2018 Jul 3;18(1):203
pubmed: 29970072
Clin Microbiol Rev. 2016 Apr;29(2):321-47
pubmed: 26960938
Eur Urol. 2008 Nov;54(5):1164-75
pubmed: 18511178
Clin Infect Dis. 2011 Mar 1;52(5):e103-20
pubmed: 21292654
Urol Int. 2014;92(2):230-6
pubmed: 24457349
Urol Int. 2018;100(3):271-278
pubmed: 29539622
JAMA. 2018 May 1;319(17):1781-1789
pubmed: 29710295
Clin Ther. 1999 Nov;21(11):1864-72
pubmed: 10890258
J Antimicrob Chemother. 2010 Nov;65(11):2459-63
pubmed: 20851815
Clin Microbiol Infect. 2019 Aug;25(8):973-980
pubmed: 30685500