Intravesical LGG VS Saline Bladder Wash RCT

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 13, 2022

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2026

Conditions
Spinal Cord InjuriesNeurogenic Bladder
Interventions
DRUG

Lactobacillus RhamnosusGG

LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.

DRUG

Saline bladder wash

Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.

Trial Locations (1)

20010

RECRUITING

MedStar National Rehabilitation Hospital, Washington D.C.

All Listed Sponsors
lead

Medstar Health Research Institute

OTHER