Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin

ISRCTN	ISRCTN76354426
DOI	https://doi.org/10.1186/ISRCTN76354426
Protocol serial number	UROLUMG11/09
Sponsor	Magna Graecia University (Italy)
Funder	Magna Graecia University (Italy)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Rocco Damiano
Scientific

Unità Operativa e Scuola Specializzazione in Urologia
Università Magna Graecia di Catanzaro
Campus di Germaneto
viale Europa
Catanzaro
88100
Italy

Primary study design	Interventional
Study design	Interventional prospective randomised double-blind placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin: an interventional prospective randomised placebo-controlled trial
Study objectives	Study drug induces a 70% decrease in the rate of urinary tract infections (UTIs) per patient/year in this study population.
Ethics approval(s)	Institutional Review Board (IRB) of Magna Graecia University, Italy, approved on the 17th September 2009 (ref: CE/441/09)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hyaluronic acid, chondroitin
Primary outcome measure(s)	Rate of UTIs per patient per year. Outcome assessment at 1, 3, 6, 9 and 12 months.
Key secondary outcome measure(s)	Outcome assessment at 1, 3, 6, 9 and 12 months: 1. Time to UTI recurrence 2. Rate of adverse events
Completion date	31/05/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/12/2009
Date of final enrolment	31/05/2010

Unità Operativa e Scuola Specializzazione in Urologia

Catanzaro
88100
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes