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11 February 2012
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| [ Print-friendly version ] |
| Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin |
| ISRCTN | ISRCTN76354426 |
| ClinicalTrials.gov identifier | |
| Public title | Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin |
| Scientific title | Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin: an interventional prospective randomised placebo-controlled trial |
| Acronym | N/A |
| Serial number at source | UROLUMG11/09 |
| Study hypothesis | Study drug induces a 70% decrease in the rate of urinary tract infections (UTIs) per patient/year in this study population. |
| Lay summary | |
| 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
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| Countries of recruitment | Italy |
| Disease/condition/study domain | Urinary tract infections (UTIs) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/12/2009 |
| Anticipated end date | 31/05/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 |
| Interventions |
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. |
| Primary outcome measure(s) | Rate of UTIs per patient per year. Outcome assessment at 1, 3, 6, 9 and 12 months. |
| Secondary outcome measure(s) |
Outcome assessment at 1, 3, 6, 9 and 12 months:
1. Time to UTI recurrence 2. Rate of adverse events |
| Sources of funding | Magna Graecia University (Italy) |
| Trial website | |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21272992 |
| Contact name | Prof Rocco Damiano |
| Address |
Unità Operativa e Scuola Specializzazione in Urologia
Università Magna Graecia di Catanzaro Campus di Germaneto viale Europa |
| City/town | Catanzaro |
| Zip/Postcode | 88100 |
| Country | Italy |
| Sponsor | Magna Graecia University (Italy) |
| Address |
Department of Urology
Policlinico Mater Domini Germaneto Viale Europa |
| City/town | Catanzaro |
| Zip/Postcode | 88100 |
| Country | Italy |
| Sponsor website: | http://www.unicz.it/urologia |
| Date applied | 03/11/2009 |
| Last edited | 02/02/2011 |
| Date ISRCTN assigned | 03/03/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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