Hyaluronic acid and chondroitin sulphate versus placebo in the prevention of urinary infections in female patients with multiple sclerosis.

• Register: ISRCTN
• Last refreshed on: 6 July 2015
• Main ID: ISRCTN10530863
• Date of registration: 07/04/2015
• Prospective Registration: Yes
• Primary sponsor: The Second University of Naples (Seconda Università degli studi di Napoli)
• Public title: Hyaluronic acid and chondroitin sulphate versus placebo in the prevention of urinary infections in female patients with multiple sclerosis.
• Scientific title: Hyaluronic acid and chondroitin sulphate (Ialuril soft gel ® HA 20 mg, CS 200 mg, curcuma longa 200 mg, quercetina 200 mg) versus placebo in the prevention of urinary infections in female patients with multiple sclerosis: a single centre, randomized, placebo-controlled, double-blind trial
• Date of first enrolment: 01/05/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10530863
• Study type: Interventional
• Study design: Placebo-controlled randomized trial (Treatment)

Countries of recruitment

Italy

Contacts

• Name: Marco De Sio

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Multiple Sclerosis
Nervous System Diseases

Intervention(s)

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 once a day for two months.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

0000/1

Source(s) of Monetary Support

IBSA (Institut Biochimique SA)