Model System:

SCI

Reference Type:

Journal article

Accession No.:

J91214

Journal:

Topics in Spinal Cord Injury Rehabilitation

Year, Volume, Issue, Page(s):

, 28, 4, 12-21

Publication Website:

Abstract:

Article describes the protocol for a comparative effectiveness randomized controlled trial of intravesical Lactobacillus rhamnosus GG (LGG) versus saline bladder wash for self-management of urinary symptoms. Comparative effectiveness trial of self-administered LGG versus saline bladder wash among 120 participants with spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction at least 6 months post SCI. The study has both treatment and prophylaxis phases. After predictive enrichment at screening, randomized participants will enter the treatment phase (6 months) in which they instill either LGG or normal saline after trigger symptoms occur (more cloudy or more foul-smelling urine). In the prophylaxis phase (6 months), participants will instill their respective intervention every 3 days after the first occurrence of trigger symptoms. Study results will provide a comparison of effects on: the Urinary Symptom Questionnaire for Neurogenic Bladder (USQNB) bladder and urine symptoms and episodes of “presumed urinary tract infections”; number of days antibiotics were used (both self-reported); days of work, school, rehabilitation, or other activity lost due to urinary symptoms; engagement with the health care system; number of instillations; satisfaction; and safety.

Author(s):

Groah, Suzanne L.|Tractenberg, Rochelle E.|

Participating Centers: