RECRUITING

Intravesical LGG VS Saline Bladder Wash RCT

Conditions

Spinal Cord Injuries Neurogenic Bladder Intermittent Catheter

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial

Quick Facts

Study Start:2022-06-13

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05230511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18 years; 2. SCI at least 6 months duration; 3. NLUTD (as determined by their SCI physician or urologist); 4. Utilizing intermittent catheterization for bladder management; and 5. Community dwelling (discharged from the acute care setting).	1. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.); 2. Use of prophylactic antibiotics; 3. Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus); 4. Immunodeficiency; 5. Any oral antibiotics within the past 2 weeks; 6. Psychologic or psychiatric conditions influencing the ability to follow instructions; 7. Participation in another study in which results would be confounded; 8. 6 months since prior exposure to intravesical LGG®; and 9. Active cancer (or within 5 years) or active autoimmune disorder

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years;
2. SCI at least 6 months duration;
3. NLUTD (as determined by their SCI physician or urologist);
4. Utilizing intermittent catheterization for bladder management; and
5. Community dwelling (discharged from the acute care setting).

1. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
2. Use of prophylactic antibiotics;
3. Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
4. Immunodeficiency;
5. Any oral antibiotics within the past 2 weeks;
6. Psychologic or psychiatric conditions influencing the ability to follow instructions;
7. Participation in another study in which results would be confounded;
8. 6 months since prior exposure to intravesical LGG®; and
9. Active cancer (or within 5 years) or active autoimmune disorder

Contacts and Locations

Study Contact

Emily Leonard, PhD

CONTACT

(202) 877-1844

emily.m.leonard@medstar.net

Inger H Ljungberg, MPH

CONTACT

(202) 877-1694

inger.h.ljungberg@medstar.net

Principal Investigator

Suzanne Groah, MD, MSPH

PRINCIPAL_INVESTIGATOR

MedStar National Rehabilitation Hospital

Study Locations (Sites)

MedStar National Rehabilitation Hospital

Washington, District of Columbia, 20010

United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

Suzanne Groah, MD, MSPH, PRINCIPAL_INVESTIGATOR, MedStar National Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-13

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-06-13

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Intermittent Catheter

Additional Relevant MeSH Terms

Spinal Cord Injuries
Neurogenic Bladder