Više o proizvodu femidoc® Utipro® Plus

za stručnu javnost

Proizvod femidoc® Utipro® Plus je medicinski proizvod u kapsulama, namijenjen za prevenciju i upravljanje ponavljajućim infekcijama mokraćnog sustava. S primarnim mehaničkim djelovanjem u crijevima smanjuje crijevno bakterijsko opterećenje uropatogenom E. coli, koja je glavni uzročnik ponavljajućeg cistitisa. Predstavlja alternativu i podršku antibiotskoj terapiji.

Podrška stručnjaka

Proizvod preporučuju međunarodno priznati stručnjaci iz područja urologije, ginekologije, gerijatrije i opće medicine.

Mehanizam djelovanja

Proizvod primarno djeluje u crijevima, a sekundarno u mokraćnom sustavu. Djeluje mehanički, smanjujući razmnožavanje uropatogenih bakterija, čime se smanjuje rizik od infekcije mokraćnog sustava.

Česta pitanja

1. Koliko vremena je potrebno da proizvod počne djelovati?

Kliničke studije pokazuju da femidoc® Utipro® Plus poboljšava simptome cistitisa u roku 5 dana liječenja i smanjuje potrebu za antibioticima (1).

2. Može li se femidoc® Utipro® Plus uzimati dugoročno?

Da, terapija se može ponavljati po potrebi u ciklusima. Klinička praksa pokazuje pozitivne učinke dugotrajnog uzimanja na prevenciju ponovnih infekcija mokraćnog sustava (2). Dugotrajno uzimanje do 9 mjeseci nema poznatih nuspojava.

3. Može li se femidoc® Utipro® Plus uzimati zajedno s antibioticima ili drugim lijekovima?

Da, proizvod nema poznatih interakcija s lijekovima.

4. Metaboliziraju li se aktivne tvari u probavnom traktu?

Ne, glavna aktivna tvar, ksiloglukan, ne metabolizira se u probavnom traktu te dospijeva do crijevne stijenke u netaknutom obliku.

5. Utječe li ksiloglukan na apsorpciju hranjivih tvari ili lijekova?

Ne, film od ksiloglukana i geloze stvara selektivnu barijeru koja pojačava i imitira postojeću crijevnu sluznicu, a ne utječe na apsorpciju hranjivih tvari ili lijekova.

6. Sprečava li film od ksiloglukana i geloze u crijevima djelovanje probiotičkih bakterija?

Ne, film od ksiloglukana i geloze ne ometa djelovanje komensalnih bakterija niti učinkovitost probiotika.

7. Kada uzimati Utipro Plus, prije, tijekom ili nakon obroka?

Unos hrane ne utječe na učinkovitost proizvoda, stoga se kapsule mogu uzimati s hranom ili bez nje.

8. Trebam li progutati kapsulu ili se može otvoriti za konzumaciju?

Preporučuje se uzimanje proizvoda prema priloženim uputama. Kapsulu je moguće otvoriti i sadržaj pomiješati s vodom ili hranom, ali organoleptičke
karakteristike (okus i miris) praška možda neće biti ugodne za izravnu konzumaciju. Unatoč tomu, proizvod zadržava svoju učinkovitost.

9. Je li femidoc® Utipro® Plus prikladan za dijabetičare?

Da. Proizvod femidoc® Utipro® Plus sadrži zanemarivu količinu sladila sukroze.

10. Je li proizvod prikladan za pacijente s crijevnim bolestima (npr. IBS, IBD)?

Da, proizvod femidoc® Utipro® Plus prikladan je i za pacijente s istovremeno prisutnim crijevnim bolestima.

1. Garcia-Larrosa, A.; Alexe, O. 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. Clin. Microbiol. 2016, 5, 1

2. Kostev K, Cai T. Cystitis and Utipro ® Plus: Real-World Evidence. Healthcare. 2023; 11(18):2564.

Znanost u pozadini

Proizvod je registrirani medicinski proizvod, potkrijepljen nizom kliničkih studija i meta-analizom. Uključen je u stručne smjernice Švicarskog udruženja ginekologa i opstetričara (SSGO, 2020) kao ne-antibiotski pristup za liječenje akutnih i ponavljajućih nekompliciranih infekcija mokraćnog sustava.

Type of evidence	Authors	Title	Summary
Guidelines	Betschart C. et al., 2020	Guideline of the Swiss Society of Gynaecology and Obstetrics (SSGO) on acute and recurrent urinary tract infections in women, including pregnancy	Utipro® Plus among the antibiotic-free approaches for the treatment of acute and recurrent uncomplicated UTIs.
A Systematic Review and Meta-Analysis	Cai T. et al., 2022	Xyloglucan, Hibiscus and Propolis in the Management of Uncomplicated Lower Urinary Tract Infections	A medical device containing xyloglucan, hibiscus and propolis is superior to comparator regimens in terms of clinical effectiveness in adult women with microbiologically confirmed or clinical suspicion of uncomplicated cystitis and is associated with a high patient compliance.
Multicentre, randomised, parallel group, double-blind, phase IV study	Costache R. C. et al., 2019	Xyloglucan-Gelose combination versus Placebo as Adjuvant Therapy to First line Antimicrobials for Uncomplicated Urinary Tract Infection in Adults	The combination of xyloglucan and gelose was safe, well tolerated and reduced bacteriological and symptomatic parameters, in particular urinary incontinence and urgency of micturition.
Randomized placebo-controlled clinical trial	Salvatorelli N. et al., 2016	A new approach to the treatment of uncomplicated cystitis	The medical device can help in preventing the recurrence of uncomplicated cystitis as well as helps to reduce antibiotic use in management of urinary tract infection in women.
Randomized double-blind, placebo-controlled trial	Garcia-Larrosa A. et al., 2016	Efficacy and safety of a medical device versus placebo in the early treatment of patients with symptoms of urinary tract infection	The medical device was more effective than placebo in improving UTI symptoms and it reduced the need for antibiotic rescue.
Observational, prospective, and multicenter study	Ortega P. et al., 2022	Clinical Experience with a Medical Device Containing Xyloglucan, Hibiscus, and Propolis for the Control of Acute Uncomplicated Urinary Tract – like Symptoms	The objective of the study was to evaluate the efficacy of a medical device in clinical practice with a cohort of women from Switzerland, paying special attention to the history of UTIs. A total of 84 women (81.6%) did not require an additional consultation, whereas 17 (16.5%) required a second one.
Observational, prospective study	T. Cai et al., 2019	Xyloglucan, hibiscus and propolis to reduce symptoms and antibiotics use in recurrent UTIs: a prospective study	This medical device is able to improve quality of life in women with rUTIs, and to reduce recurrence rate and the use of antibiotics.
Observational, retrospective, cross-sectional study	Kostev K. and Cai T., 2023	Cystitis and Utipro® Plus: Real-World Evidence	The use of Utipro® Plus is able to decrease UTI recurrence and can lead to the reduction of antibiotic prescriptions and disease burden in individuals affected by uncomplicated cystitis.
Review	Guglietta A., 2017	Recurrent urinary tract infections in women: risk factors, etiology, pathogenesis and prophylaxis	Review of the role of alternative non-antibiotic based approaches, such as mechanical barrier protection of the intestinal mucosa in UTI management.
Review	Rodriguez Mañas L., 2020	Urinary tract infections in the elderly: a review of disease characteristics and current treatment options	New treatment strategies that offer a safe and effective non-antimicrobial means of managing UTIs could have an important role in the elderly.
Review	Piqué N. et al., 2018	Xyloglucan, a plant polymer with barrier protective properties over the mucous membranes: an overview	Xyloglucan, endowed with film-forming protective barrier properties, is a safe no-pharmacological alternative for the management of different diseases.
In vivo study	Olier M. et al., 2017	Evaluation of reticulated gelatine hibiscus propolis against intestinal commensal species commonly associated with urinary tract infections	The medical device alters the intestinal niche occupied by uropathogens such as E. coli.
In vivo study	Esposito E. et al., 2020	Efficacy of Xyloglucan against Escherichia coli Extraintestinal Urinary Tract Infection: An in vivo Study	The study supports the potential beneficial effect of xyloglucan or xyloglucan-gelose in preventing extraintestinal UTIs by means of reducing E. coli colonies.
In vivo study	Esposito E. et al., 2018	Protective Effects of Xyloglucan in Association with the Polysaccharide Gelose in an Experimental Model of Gastroenteritis and Urinary Tract Infections	Rats were infected by oral administration of Salmonella enterica and Enterococcus hirae. The compound reduced the number of bacterial colonies in the urinary tract favoring elimination by feces. The results obtained in the present study suggest that the protective barrier properties of xyloglucan plus gelose allow the prevention of GE and UTI in models of infections in rats.
In vitro study	Fraile B. et al., 2017	Xyloglucan, hibiscus and propolis for the prevention of urinary tract infections. Results of in vitro studies	Xyloglucan, hibiscus and propolis did not alter E. coli cell integrity in intestinal and uroepithelial cell models and were devoid of antibacterial activity. The non-pharmacological barrier properties of these components confirm the role of the medical device for the management of urinary tract infections.
In vitro study	De Servi B. et al., 2016	Efficacy of a medical device containing xyloglucan gelatin against Escherichia coli invasion of intestinal epithelial cells: results of an in vitro study	The medical device creates a protective physical barrier on epithelial intestinal cells in vitro, which reduces the settling of E coli reservoirs.
Case reports	Cai T., Konstantidinis C., Ward S., 2021	A non-pharmacological approach to the treatment of urinary tract infections: case reports with Utipro® Plus	Publication on case series referring about the benefits of Utipro® Plus in some challenging cases of urinary infections. In this new publication, the product has proven its usefulness as a non-pharmacological approach in recurrent UTIs, thus allowing a rational use of antibiotics.