Spinal-injured neuropathic bladder antisepsis (SINBA) trial.
OBJECTIVE
To determine whether Methenamine Hippurate (MH) or cranberry tablets prevent urinary tract infections (UTI) in people with neuropathic bladder following spinal cord injury (SCI).


METHODS
Double-blind factorial-design randomized controlled trial (RCT) with 2 year recruitment period from November 2000 and 6 month follow-up.


METHODS
In total, 543 eligible predominantly community dwelling patients were invited to participate in the study, of whom 305 (56%) agreed.


METHODS
Eligible participants were people with SCI with neurogenic bladder and stable bladder management. All regimens were indistinguishable in appearance and taste. The dose of MH used was 1 g twice-daily. The dose of cranberry used was 800 mg twice-daily. The main outcome measure was the time to occurrence of a symptomatic UTI.


RESULTS
Multivariate analysis revealed that patients randomized to MH did not have a significantly longer UTI-free period compared to placebo (HR 0.96, 95% CI: 0.68-1.35, P=0.75). Patients randomized to cranberry likewise did not have significantly longer UTI-free period compared to placebo (HR 0.93, 95% CI: 0.67-1.31, P=0.70).


CONCLUSIONS
There is no benefit in the prevention of UTI from the addition of MH or cranberry tablets to the usual regimen of patients with neuropathic bladder following SCI.
Lee
B B
BB
Spinal Medicine Department, Prince of Wales Hospital, Sydney, New South Wales, Australia.
Haran
M J
MJ
Hunt
L M
LM
Simpson
J M
JM
Marial
O
O
Rutkowski
S B
SB
Middleton
J W
JW
Kotsiou
G
G
Tudehope
M
M
Cameron
I D
ID
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000892:Anti-Infective Agents, Urinary / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006626:Hippurates / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008709:Methenamine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D015999:Multivariate Analysis; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D013119:Spinal Cord Injuries / Q000150:complications*; D013607:Tablets; D017211:Treatment Failure; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy* / Q000209:etiology*; D014552:Urinary Tract Infections / Q000517:prevention & control*; D029799:Vaccinium macrocarpon / Q000737:chemistry*
D000892:Anti-Infective Agents, Urinary; D006626:Hippurates; D010936:Plant Extracts; D013607:Tablets; D008709:Methenamine; C011481:methenamine hippurate