Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin
| ISRCTN | ISRCTN76354426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76354426 |
| Secondary identifying numbers | UROLUMG11/09 |
- Submission date
- 03/11/2009
- Registration date
- 03/03/2010
- Last edited
- 02/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rocco Damiano
Scientific
Scientific
Unità Operativa e Scuola Specializzazione in Urologia
Università Magna Graecia di Catanzaro
Campus di Germaneto
viale Europa
Catanzaro
88100
Italy
Study information
| Study design | Interventional prospective randomised double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2009 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Italy
Study participating centre
Unità Operativa e Scuola Specializzazione in Urologia
Catanzaro
88100
Italy
88100
Italy
Sponsor information
Magna Graecia University (Italy)
University/education
University/education
Department of Urology
Policlinico Mater Domini
Germaneto
Viale Europa
Catanzaro
88100
Italy
| Website | http://www.unicz.it/urologia |
|---|---|
"ROR" |
https://ror.org/0530bdk91 |
Funders
Funder type
University/education
Magna Graecia University (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No |
