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| autoid | 23 |
| crg_id | CRG090500012 |
| titleoftrial | Spinal-Injured Neuropathic Bladder Antisepsis (SINBA) Trial |
| acronymnoftrial | SINBA |
| website | http:www.medicalinformatics.net |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Lee |
| leadgivennames | Bon San Bonne |
| leadposition | Staff Specialist |
| leaddepartment | Spinal Medicine Department |
| leadorganisation | Prince of Wales Hospital Sydney |
| leadaddress | The Prince of Wales Hospital, level 2 High Street entrance Randwick Sydney NSW 2031 Australia |
| leademail | blee@medicalinformatics.net |
| leadphone | +61 2 90164684 |
| leadfax | +61 2 9382 5602 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Lee |
| contactgivennames | Bon San Bonne |
| contactposition | Staff Specialist |
| contactdepartment | Spinal Medicine Department |
| contactorganisation | Prince of Wales Hospital |
| contactaddress | The Prince of Wales Hospital, level 2 High Street entrance Randwick Sydney NSW 2031 Australia |
| contactemail | blee@medicalinformatics.net |
| contactphone | +61 2 90164684 |
| contactfax | +61 2 9382 5602 |
| funding | industry |
| otherfunding | Insurance industry |
| fundingnameofsponsors | Motor Accident Authority NSW (financial),Brucia Pharmaceutical (non financial) |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | 2000 |
| actualstart | |
| proposedcompletiondate | 2003 |
| actualcompletiondate | |
| multi_center_study | yes |
| numberofcentres | 3 |
| multi_national_study | no |
| countrycentres | Australia |
| researchquestion | Do the Urinary Antiseptics Methenamine Hippurate or Crancerry prevent Urinary Tract Infections in people with Spinal Cord Injuries |
| study_status_recruitment | Recruitment completed |
| study_status_recruitment_follow | Completed |
| healthcarecondition | Urinary Tract Infection |
| intervention1 | Methenamine Hippurate and Cranberry Placebo |
| intervention2 | Cranberry and Methenamine Hippurate Placebo |
| intervention3 | Cranberry Placebo and Methenamine Hippurate Placebo |
| intervention4 | Methenamine Hippurate and Cranberry |
| participants_gender | both |
| participants_other | adults |
| age | N/A |
| totalrecruitment | 350 |
| inclusion | The eligibility criteria for the trial were: spinal cord injury with neurogenic bladder; stable bladder management with either indwelling urethral or suprapubic catheter, intermittent catheterization, or reflex voiding with or without a condom drainage device; absence of complex urological or serious renal or hepatic pathology; not being prescribed antibiotics at the time of enrolment and absence of symptoms of a urinary tract infection at the time of enrolment. Patients had to be willing to stop any intercurrent urinary antiseptics prior to entering the trial. Patients were ineligible if they had a previous allergy to any of the tested interventions. |
| exclusion | Patients had to be willing to stop any intercurrent urinary antiseptics prior to entering the trial. Patients were ineligible if they had a previous allergy to any of the tested interventions. (See also Inclusion criteria) |
| primaryoutcomes | The primary endpoint was an occurrence of a symptomatic urinary tract infection |
| secondaryoutcomes | Secondary outcome measures were bacteriological urinary analysis at time of primary endpoint and adverse events |
| reference | Bon San Bonne Lee, Mark Haran, Lianne Hunt, Judy Simpson, Obayd Marial, Sue Rutkowski, James Middleton, George Kotsiou, Mark Tudehope. Spinal-Injured Neuropathic Bladder Antisepsis (SINBA) Trial. 43rd ISCos 2004, Annual Scientific Meeting, Sept 26-29 2004, Athens Greece Lee BB, Haran MJ, Hunt LM, Simpson JM, Marial O, Rutkowski SB, Middleton JW, Kotsiou G, Tudehope M, Cameron ID Spinal-injured neuropathic bladder antisepsis (SINBA) trial. Spinal Cord 2006; 1-9 [advanced online publication Oct 17 2006]. doi:10.1038/sj.sc.3101974).Print publication: Spinal Cord 45, August 2007 pages 542-550. |