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Intravesical LGG VS Saline Bladder Wash RCT

ConditionsSpinal Cord InjuriesNeurogenic Bladder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

About this trial

This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

SCI at least 6 months duration;

NLUTD (as determined by their SCI physician or urologist);

Utilizing intermittent catheterization for bladder management; and

Disqualifiers

Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);

Use of prophylactic antibiotics;

Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);

Immunodeficiency;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactobacillus RhamnosusGG

    Drug

    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.

  • Saline bladder wash

    Drug

    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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)Experimental treatment 1 intervention
Group B: Intravesical Bladder Wash (Treatment Phase)Other 1 intervention
Group C: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase)Experimental treatment 1 intervention
Group D: Intravesical Bladder Wash (Prophylaxis Phase)Other 1 intervention

Trial outcomes

Primary outcomes

1

International SCI Lower Urinary Tract Function Basic Data Set

A tool that describes urinary tract impairment, awareness of need to empty bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year. Score is not associated with outcome.

Time frame
Day 1
2

International SCI Core Data Set

Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcome.

Time frame
Day 1
3

NINDS Medical History CDE

A brief medical history using body system categories. Score is not associated with outcomes.

Time frame
Day 1
4

NINDS Prior and Concomitant Medications CDE

Contains whether or not the participant is taking a medication during the study protocol, name of the medication, reason for medication, medication dose, frequency, start and end dates, and free text. Score is not associated with outcomes.

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

Source ClinicalTrials.gov
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