Urinary Tract Infection (Diagnosis)
Conditions
Brief summary
The aim of this study is to evaluate whether a dietary supplement based on D-mannose, collagen, hyaluronic acid, chondroitin sulphate, enhanced by the properties of quercetin plus propolis (Proqutin ®) and Bacillus Coagulans, eventually associated with antimicrobial prophylaxis, could be effective in preventing recurrent UTIs and improving related quality of life.
Interventions
Fosfomycin trometamol 3 g administered orally in a single dose every ten days for three months, repeated every three months for a total treatment duration of 12 months.
Dietary supplement of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.
Fosfomycin trometamol 3 g administered orally in a single dose every ten days for three months, repeated every three months for a total treatment duration of 12 months, combined with an oral formulation of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.
Sponsors
Study design
Masking description
Participants are blind to treatment arm
Eligibility
Inclusion criteria
* a history of rUTIs (defined by EAU guidelines as a frequency of at least three UTIs per year, or two UTIs in the past six months in the last 12 months, confirmed by positive urine cultures * not undergone any previous treatment for their condition.
Exclusion criteria
* age under or over limit * concurrent antimicrobial treatment * any ongoing treatment that could influence study outcomes, * congenital or post-surgical urinary tract anomalies * immunodeficiency or HIV infection * ongoing pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of urinary tract infections per month | 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| ICIQ-FLUTS scores | 6 and 12 months |
| Number of women matching recurrent urinary tract infection criteria | 12 months |
Countries
Italy