Effects of Intravesical Lactobacillus Rhamnosus GG on Urinary Symptom Burden in People with Neurogenic Lower Urinary Tract Dysfunction

被引:31
作者
Tucker, Jason D. [1 ,2 ]
Goetz, Lance L. [3 ]
Duncan, Michael B. [1 ]
Gilman, Jared B. [2 ]
Elmore, Lynne W. [4 ]
Sell, Scott A. [5 ]
McClure, Michael J. [6 ]
Quagliano, Peter, V [7 ]
Martin, Caroline C. [8 ]
机构
[1] iOrthoBiologix, Charlotte, NC 28277 USA
[2] Virginia Commonwealth Univ Hlth Syst, Dept Phys Med & Rehabil, Richmond, VA 23298 USA
[3] Hunter Holmes McGuire Vet Affairs Med Ctr, Spinal Cord Injury & Disorders Serv, Richmond, VA USA
[4] Amer Canc Soc, Atlanta, GA 30329 USA
[5] St Louis Univ, Pk Coll Engn Aviat & Technol, Dept Biomed Engn, St Louis, MO 63103 USA
[6] Virginia Commonwealth Univ, Dept Biomed Engn, Richmond, VA USA
[7] Hunter Holmes McGuire Vet Affairs Med Ctr, Dept Radiol, Richmond, VA USA
[8] Hunter Holmes McGuire Vet Affairs Med Ctr, Dept Pathol, Richmond, VA USA
关键词
SPINAL-CORD-INJURY; CLINICAL-PRACTICE; INFECTION; BLADDER; PREVENTION; GUIDELINES;
D O I
10.1002/pmrj.12561
中图分类号
R49 [康复医学];
学科分类号
100215 ;
摘要
Objective To test the effectiveness of intravesical Lactobacillus rhamnosus GG (LGG) to reduce the burden of urinary symptoms for individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC). Design A three-phase study (6 months each in baseline, intervention, and washout). Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly. Setting Nationwide (United States). Participants Ninety-six adults and seven children with SCI/D. Interventions In response to one or both of the SMP-Pro trigger urinary symptoms, "cloudier" or "foul smelling" urine, participants self-administered using a clean urinary catheter an LGG+ Normal Saline instillate once or twice in a 30-hour period. Main Outcome Measures Change in USQNB-IC burden was adjusted individually according to the previous phase for four symptom types. Adjusted changes in burden between the intervention and washout phases were analyzed using one-sample t-tests. Holm correction was applied for the four types of symptoms: A, clinically actionable; B1, bladder function; B2, urine quality; and C, other. Results During the intervention phase, participants met SMP-Pro instillation criteria 3.83 times on average (range 1-20). An average of 5.6 doses of LGG were instilled. For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted P < .05). Conclusions Self-instilled LGG seemed to improve "clinically actionable" (A) and "urine quality" (B2) symptom burden. No changes were observed for those who did not instill. This first-in-human clinical trial supports ongoing research of intravesical LGG, and the SMP-Pro for urinary symptoms.
引用
收藏
页码:707 / 719
页数:13
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