Multiple Sclerosis Nervous System Diseases
Conditions
Interventions
Eligible patients will receive 1 capsule twice a day of HA and CS (Ialuril soft gel ® HA 20 mg, CS 200 mg, Curcuma longa 200 mg, Quercetina 200 mg), or a placebo every day for two weeks and then
Sponsors
The Second University of Naples (Seconda Università degli studi di Napoli)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Age >18years 3. Diagnosis of MS according to the McDonald Revised criteria 4. Expanded Disability Status Scale less 10000 CFU/ml of an identified pathogen in the last year with clinical symptoms
Exclusion criteria
Exclusion criteria: 1. Age >80 years 2. UTIs in the previous year < 3 3. Concomitant UTI at the beginning of the study or ongoing prophylactic antibiotic treatment 4. Known neoplasia, urinary stone or abnormality of the urinary tract 5. Chronic kidney disease, diabetes mellitus, use of spermicides or intrauterine devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean rate of UTI episodes per patient per year. A UTI episode was defined in the form of significant bacteriuria as >10000 CFU/ml of midstream urine with clinical symptoms. Assessments measured at baseline and after 4,8 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to UTI recurrence (defined as the time relapsed between the first administration and the first recurring infection) 2. Variation in void frequency and volume 3. Impact of therapy on QoL 4. Rate of adverse events Assessments measured at baseline and after 4,8 and 12 months. | — |
Countries
Italy
Outcome results
None listed