Comparison of Effectiveness of a Food Supplement Product vs Fosfomycin in the Treatment of Female Recurrent Urinary Tract Infections: Preliminary Results of a Multicenter Case-Control Study
Authors: Misasi Giulia , Catucci Claudia Lucia , Nardoni Samuele , Turchi Beatrice , Pisacreta Elena , Xhaferi Rudi , Simoncini Tommaso , De Nunzio Cosimo , Russo Eleonora , Li Marzi Vincenzo 
Published: December 2024

Introduction an objective: Urinary tract infections (UTIs) are a significant health concern with high costs and poor quality of life (QoL) impact. Managing recurrent UTIs (rUTI) in women requires effective treatments that relieve symptoms and reduce recurrence, while also sparing antibiotics due to rising resistance. This study evaluates the efficacy of a nutritional supplement in reducing UTI recurrences and improving QoL compared to antibiotic therapy. Materials and Methods: This is a multicentric case-control study involving female patients with rUTI. We compared the efficacy of a dietary supplement containing D-mannose 3gr, Palmitoylethanolamide 600 mg, N-acetylcysteine 600 mg, Lactobacillus rhamnosus 2x109, Hibiscus extract 400 mg- (1 sachet/day for 14 days per month for 6 months) against a low dose of Fosfomycin 3 g (one sachet every 10 days for 6 months). Patients were clinically (age, BMI, hormonal status, smoking, and sexual activity) and microbiologically (urine cultures with antibiograms) evaluated at baseline, after 3 months, and after 6 months of therapy. Validated questionnaires were administered to evaluate QoL (WHO-5) and satisfaction (PGI-I). UTI was defined by positive urine culture (bacterial load &ge;105 CFU/ml) and patient reported lower urinary tract symptoms (LUTS). Results: A total of 55 patients were enrolled in the nutritional supplement group (NGroup) and 34 in the Fosfomycin group (FGroup). In the NGroup, the median age was 62.2&plusmn;16.0, a median BMI of 27.2&plusmn;3.8, 13 (23.6%) were smokers, 29 (52.7%) were sexually active, and 42 (76.4%) were postmenopausal. The mean number of UTI at baseline was 1.87&plusmn;0.75, decreasing to 0.51&plusmn;0.63 at 3 months (p&lt;0.001) and 0.28&plusmn;0.54 at 6 months (p&lt;0.001). Adverse events (AEs) reported were 2 (3.6%) at 3 months and 1 (2.1%) at 6 months (mild gastrointestinal symptoms in all cases). Questionnaires indicated improvements in both QoL (WHO-5: 18.90&plusmn;3.91 at 3 months and 20.2 &plusmn; 2.55 at 6 months; p&lt;0.001) and satisfaction (PGI-I: 3.04&plusmn;1.61 at 3 months and 2.43&plusmn;1.26 at 6 months; p&lt;0.001). In the FGroup, demographic data revealed a median age of 62.9&plusmn;12.9, a median BMI of 23.5&plusmn;3.0, 10 (29.4%) were smokers, 30 (88.2%) were postmenopausal and 18 (54.5%) were sexually active. The mean number of UTI at baseline was 2.68&plusmn;0.81, also in this group we have an improvement at 3 months 0.87&plusmn;0.54 (p&lt;0.001), and at 6 months 0.67&plusmn;0.80 (p&lt;0.001). No AEs were reported. QoL improved (WHO-5: 17.80&plusmn;1.40 to 21.4&plusmn;2.19, p&lt;0.001), but satisfaction declined (PGI-I increased from 2.20&plusmn;0.41 to 4.05&plusmn;0.69; p&lt;0.001). No statistically significant differences were observed between the 2 groups in terms of demographic data (except for BMI), AEs, WHO-5 questionnaire scores, and UTI changes (p&gt;0.05). Lower satisfaction was observed in FGroup. Conclusions: Despite the limitations of this study, including a small patient population and the absence of a third placebo control group of patients, the oral preparation containing D-mannose, PEA, N-acetylcysteine, Lactobacillus rhamnosus and hibiscus extract may be a viable alternative to antibiotics for reducing rUTI in women.