Intravesical Lactobacillus rhamnosus GG versus Saline Bladder Wash: Protocol for a Randomized, Controlled, Comparative Effectiveness Clinical Trial.

ABSTRACT:

Background

Complicated urinary tract infection (cUTI) is pervasive and costly among people with spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction (NLUTD).

Objectives

To describe the protocol for a comparative effectiveness randomized controlled trial of intravesical Lactobacillus rhamnosus GG (LGG) versus saline bladder wash (BW) for self-management of urinary symptoms.

Methods

Comparative effectiveness trial of self-administered LGG versus saline bladder wash among 120 participants with SCI+NLUTD 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 t

SUBMITTER: Groah SL 

PROVIDER: S-EPMC9678213 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature