Hyaluronic acid and chondroitin sulphate versus placebo in the prevention of urinary infections in female patients with multiple sclerosis.
Completed
- Conditions
- Multiple SclerosisNervous System Diseases
- Registration Number
- ISRCTN10530863
- Lead Sponsor
- The Second University of Naples (Seconda Università degli studi di Napoli)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
1. Female
2. Age >18years
3. Diagnosis of MS according to the McDonald Revised criteria
4. Expanded Disability Status Scale less < 8
5. Documented history of recurrent cystitis defined as at least three episodes of uncomplicated infection documented by urine culture with the isolation of >10000 CFU/ml of an identified pathogen in the last year with clinical symptoms
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>Assessments measured at baseline and after 4,8 and 12 months.
- Secondary Outcome Measures
Name Time Method 1. Time to UTI recurrence (defined as the time relapsed between the first administration and the first recurring infection)<br>2. Variation in void frequency and volume<br>3. Impact of therapy on QoL<br>4. Rate of adverse events<br><br>Assessments measured at baseline and after 4,8 and 12 months.