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For Peer Review Only BMJ Open BMJ Open: first published as 10.1136/bmjopen-2015-009669 on 31 March 2016. Downloaded from Intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS) for the treatment of female recurrent urinary tract infections: a European multicenter nested case-control study For peer review only Journal: BMJ Open Manuscript ID: bmjopen-2015-009669 Article Type: Research Date Submitted by the Author: 10-Aug-2015 Complete List of Authors: Ciani, Oriana; University of Exeter , University of Exeter Medical School; CeRGAS Bocconi, Arendsen, Erik; Diaconessenhuis, Dept. of Urology Romancik, Martin; St. Cyril and Method University Hospital, Dept. of Urology Lunik, Richard; Fakultná nemocnica s poliklinikou, Dept. of Urology Costantini, Elisabetta; University of Perugia, Dept. of Surgical and Biomedical Science Di Biase, Manuel; University of Perugia, Dept. of Surgical and Biomedical Science Morgia, Giuseppe; University of Catania, Dept. of Urology http://bmjopen.bmj.com/ Fragala', Eugenia; University of Catania, Dept. of Urology Tomaskin, Roman; Jessenius School of Medicine, Dept. of Urology Bernat, Marian; Fakultná nemocnica s poliklinikou, Dept. of Urology Guazzoni, Giorgio; Humanitas Clinical and Research Center, Dept. of Urology Tarricone, Rosanna; Bocconi University, Dept. of Policy Analysis and Public Management Lazzeri, Massimo; Humanitas Clinical and Research Center, Dept. of Urology on September 29, 2021 by guest. Protected copyright. <b>Primary Subject Urology Heading</b>: Secondary Subject Heading: Infectious diseases Urinary tract infections < UROLOGY, Antimicrobial Resistance, Hyaluronic Keywords: acid, chondroitin sulphate For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 25 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2015-009669 on 31 March 2016. Downloaded from 1 2 3 4 5 Intravesical administration of combined hyaluronic 6 7 8 acid (HA) and chondroitin sulphate (CS) for the 9 10 treatment of female recurrent urinary tract infections: 11 12 a European multicenter nested case-control study 13 14 15 For1 peer2 review 3 only 4 16 Oriana Ciani , Erik Arendsen , Martin Romancik , Richard Lunik , Elisabetta 17 Costantini5, Manuel Di Biase 5, Giuseppe Morgia6, Eugenia Fragalà6, 18 7 8 9 19 Tomaskin Roman , Marian Bernat , Giorgio Guazzoni , Rosanna 20 1,10 9 21 Tarricone , Massimo Lazzeri 22 23 1 24 Centre For Research on Health and Social Care Management, Università 25 26 Bocconi, via Rontgen, 1, 20136, Milan, Italy 27 2 Diaconessenhuis, Dept. of Urology, Leiden, The Netherlands 28 3 29 St. Cyril and Method University Hospital, Dept. of Urology, Bratislava, 30 31 Slovakia 32 4 Fakultná nemocnica s poliklinikou, Dept. of Urology, Prešov, Slovakia 33 5 http://bmjopen.bmj.com/ 34 University of Perugia, Dept. of Surgical and Biomedical Science, Urology 35 36 and Andrology Clinic, Perugia, Italy 37 6 University of Catania, Dept. of Urology, Catania, Italy 38 7 39 Jessenius School of Medicine, University Hospital, Dept. of Urology, Martin, 40 41 Slovakia 42 8 Fakultná nemocnica s poliklinikou, Dept of Urology, Nové Zámky, Slovakia on September 29, 2021 by guest. Protected copyright. 43 9 44 Humanitas Clinical and Research Center, Humanitas University, Department 45 46 of Urology, Milan, Italy 47 10 Università Bocconi, Department of Policy Analysis and Public Management, 48 49 Via Roentgen, 1, 20136 Milano, Italy 50 51 Correspondence to: [email protected] 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 1 BMJ Open Page 2 of 25 BMJ Open: first published as 10.1136/bmjopen-2015-009669 on 31 March 2016. Downloaded from 1 2 3 Abstract 4 5 Objectives: To compare the clinical effectiveness of the intravesical 6 administration of combined hyaluronic acid and chondroitin sulphate (HA + 7 8 CS) vs. current standard management in adult women with recurrent urinary 9 10 tract infections (RUTIs). 11 Setting: A EU-based, multicenter, retrospective nested case-control study. 12 13 Participants: 276 adult women treated for RUTIs starting from 2009 to 2013. 14 15 Interventions:For Patients peer treated withreview either intravesical only administration of HA + 16 CS or standard of care (antimicrobial/immunoactive 17 18 prophylaxis/probiotics/cranberry). 19 20 Primary and secondary outcome measures: The primary outcome was 21 occurrence of bacteriologically confirmed recurrence within 12 months. 22 23 Secondary outcomes were time to recurrence, total number of recurrences, 24 25 health related quality of life and healthcare resource consumption. Crude and 26 adjusted results for unbalanced characteristics are presented. 27 28 Results: 181 patients treated with HA + CS and 95 patients treated with 29 30 standard of care from 7 centers were included. The crude and adjusted OR 31 32 (95% CI) for the primary endpoint were 0.77 (0.46 to 1.28) and 0.51 (0.27 to 33 0.96), respectively. The benefit of intravesical HA + CS therapy improves http://bmjopen.bmj.com/ 34 35 when the number of instillations is ≥ 5. 36 37 Conclusions: In real world setting, bladder instillations of combined HA + CS 38 reduces by 49% the risk of bacteriologically confirmed recurrences compared 39 40 to the current standard management of RUTIs. Total incidence rates and 41 42 hazard rates were instead non significantly different between the two groups on September 29, 2021 by guest. Protected copyright. 43 after adjusting for unbalanced factors. In contrast to what happens with 44 45 antibiotic prophylaxis, the effectiveness of HA + CS therapy improves over 46 47 time. In an era of worryingly increased antimicrobial resistance, these findings 48 confirm the promising role of the HA + CS reinstatement therapy for 49 50 prevention and treatment of RUTIs. 51 52 Trial registration: ClinicalTrials.gov NCT02016118 53 54 55 Article Summary 56 57 'Strengths and limitations of this study' 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 2 Page 3 of 25 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2015-009669 on 31 March 2016. Downloaded from 1 2 3 • Real world data show bladder instillations of combined hyaluronic acid 4 5 and chondroitin sulphate reduce the risk of bacteriologically confirmed 6 urinary tract infections vs current standard management 7 8 • Number of instillations is an important marker of success for this non- 9 10 antimicrobial therapy 11 12 • Due to the retrospective observational design, these findings need 13 confirmation from prospective and preferably randomised studies 14 15 For peer review only 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 42 on September 29, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 3 BMJ Open Page 4 of 25 BMJ Open: first published as 10.1136/bmjopen-2015-009669 on 31 March 2016. Downloaded from 1 2 3 4 Background 5 6 Urinary tract infection (UTI) is a major healthcare concern in women with an 7 annual incidence of 30 per 1000 (1). Nearly 33% of women will have had at 8 9 least one UTI episode, with characteristics of acute cystitis, requiring 10 11 antimicrobial therapy by the age of 24 years and as many as 60% of women 12 report having had a UTI in their lifetime (2, 3). 13 14 UTIs have a propensity to recur (4, 5); evidence shows that between 24% and 15 For peer review only 16 50% of initial episodes are followed by a second infection within six months 17 (6-9). A widely accepted definition of RUTIs is two or more UTI episodes over 18 19 six months, or three or more episodes over 12 months (10). On a population 20 21 scale, high incidence and prevalence of RUTIs results in considerable 22 healthcare costs, at the individual level the impact of this condition on health 23 24 related quality of life (HRQoL) is not negligible (11-13). 25 26 The pathogenesis of RUTI involves colonisation of the vagina with 27 uropathogenic bacteria and subsequent migration per urethra to the bladder. 28 29 About 68-77% of recurrences caused by Escherichia coli involve strains 30 31 genetically indistinguishable from those that caused previous infections (14). 32 The diagnosis is often made on clinical presentation with local genitourinary 33 http://bmjopen.bmj.com/ 34 symptoms of dysuria, frequency, and urgency or hesitancy appearing 35 36 suddenly (14). However, urine culture is useful in women presenting with 37 RUTI to confirm the diagnosis, direct antimicrobial therapy and exclude 38 39 infection from overactive bladder or interstitial cystitis (15). Evidence based 40 41 clinical practice guidelines recommend empiric initial therapy for acute on September 29, 2021 by guest. Protected copyright. 42 management or continuous antimicrobial therapy or self-initiated therapy and 43 44 prophylaxis, either antimicrobial or non-antimicrobial based (16, 17). 45 46 The choice of specific strategy for care depends on the number of 47 recurrences experienced per year, the patient’s preferences and careful 48 49 review of modifiable risk factors (14, 18). As the second most common reason 50 51 for prescribing antibiotics (following otitis media), there is currently increasing 52 concern about empiric use of these agents due to increased antimicrobial 53 54 resistance. Antibiotic use selects for resistant pathogens: a major risk factor 55 56 for an antibiotic-resistant UTI is prior antibiotic use (5). In an international 57 survey investigating the prevalence and susceptibility of pathogens causing 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 4 Page 5 of 25 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2015-009669 on 31 March 2016.
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