Samay Sappal1, Lance L Goetz2,3, Randy Vince4, Adam P Klausner4. 1. 1School of Medicine, Virginia Commonwealth University, Richmond, VA USA. 2. 2Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA USA. 3. 3Spinal Cord Injury and Disorders Service, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, VA USA. 4. 4Division of Urology, Department of Surgery, Virginia Commonwealth University, Richmond, VA USA.
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.
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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