Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UROLUMG11/09
Study information
Scientific title
Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin: an interventional prospective randomised placebo-controlled trial
Acronym
Study hypothesis
Study drug induces a 70% decrease in the rate of urinary tract infections (UTIs) per patient/year in this study population.
Ethics approval
Institutional Review Board (IRB) of Magna Graecia University, Italy, approved on the 17th September 2009 (ref: CE/441/09)
Study design
Interventional prospective randomised double-blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urinary tract infections (UTIs)
Intervention
Patients will be randomised to receive:
1. Intravesical instillations of sodium HA (high molecular weight) 1.6% and CS 2.0% dose 50 ml of saline
2. Intravesical instillations of 50 ml saline (controls)
Both groups will be given therapy once weekly for 4 weeks and then once week or monthly for 5 months. Total follow-up: 12 months.
Intervention type
Drug
Phase
Phase II
Drug names
Hyaluronic acid, chondroitin
Primary outcome measure
Rate of UTIs per patient per year. Outcome assessment at 1, 3, 6, 9 and 12 months.
Secondary outcome measures
Outcome assessment at 1, 3, 6, 9 and 12 months:
1. Time to UTI recurrence
2. Rate of adverse events
Overall trial start date
01/12/2009
Overall trial end date
31/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 18 - 80 years old
2. Spontaneous urination
3. Greater than three uncomplicated UTIs/previous year
4. Free from UTIs at the beginning of study
5. No ongoing prophylactic antibiotic treatment
6. Able to provide informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Greater than 50 ml residual urine
2. Neurological bladder disease
3. Known neoplasia, urinary stone or urinary tract abnormality
4. Use of indwelling catheter
5. Renal insufficiency
6. Diabetes
7. Current corticosteroid use
8. Pregnancy
9. Immunosuppressive disease
Recruitment start date
01/12/2009
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Italy
Trial participating centre
Unità Operativa e Scuola Specializzazione in Urologia
Catanzaro
88100
Italy
Sponsor information
Organisation
Magna Graecia University (Italy)
Sponsor details
Department of Urology
Policlinico Mater Domini
Germaneto
Viale Europa
Catanzaro
88100
Italy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Magna Graecia University (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21272992
Publication citations
-
Results
Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R, Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial., Eur. Urol., 2011, 59, 4, 645-651, doi: 10.1016/j.eururo.2010.12.039.