Abstract
Study design
This study was a double-blind, placebo-controlled trial of a concentrated PACs compound (36 mg/capsule), in veterans with SCI and neurogenic lower urinary tract dysfunction (NLUTD) requiring intermittent catheterization (IC) over a 15-day period.
Objectives
The objective of this study was to evaluate the acute effects of concentrated proanthocyanidins (PACs) in the cranberry supplement ellura® on bacteriuria, leukocyturia, and subjective urine quality in catheter-dependent veterans with SCI.
Setting
Spinal cord injury center (outpatient clinic and inpatient unit).
Methods
Participants with positive urine bacterial colonization (≥50 K CFU/ml) were randomized to once daily concentrated PACs or identical placebo and followed with daily (in-patients) or twice weekly (out-patients) urine cultures with colony forming units per milliliter (cfu/ml) range (bacteriuria), microscopic urine white blood cells per high-powered field (wbc/hpf) quantification (leukocyturia), and surveys assessing urine clarity, odor, color, sediment, and overall satisfaction. A repeated measure analysis of variance was used to compare treatment vs. control and evaluate serial trends.
Results
A total of 13 male participants (7 randomized to concentrated PACs, 6 to placebo) completed the trial. There was no significant decrease over the study period in colony forming units per milliliter (cfu/ml) or log(wbc/hpf) in the treatment vs. the control group. Patients receiving concentrated PACs rated the clarity, odor, color, sediment, and overall satisfaction of their urine as insignificantly improved compared to placebo.
Conclusions
Acutely, there was no reduction of bacteriuria and pyuria or improvement in subjective urine quality for SCI patients treated with daily concentrated PACs.
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Funding
This study was funded in part by the Trophikos, LLC, the manufacturer of the cranberry supplement, ellura®.
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Sappal, S., Goetz, L.L., Vince, R. et al. Randomized trial of concentrated proanthocyanidins (PAC) for acute reduction of bacteriuria in male veterans with spinal cord injury utilizing clean intermittent catheterization. Spinal Cord Ser Cases 4, 58 (2018). https://doi.org/10.1038/s41394-018-0087-2
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DOI: https://doi.org/10.1038/s41394-018-0087-2
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