RECRUITING

Intravesical Lactobacillus for Urinary Symptoms Among People with NLUTD Who Use Indwelling Catheters

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

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.

Official Title

Intravesical Lactobacillus for Urinary Symptoms Among People with NLUTD Who Use Indwelling Catheters

Quick Facts

Study Start:2020-01-10
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04323735

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 CriteriaExclusion Criteria
  1. * Neurogenic bladder for at least 6 months;
  2. * Utilizing indwelling catheterization for bladder management;
  3. * Women must be premenopausal and not currently menstruating;
  4. * Community dwelling
  5. * physical disability
  1. * Use of prophylactic antibiotics;
  2. * Instillation of intravesical antimicrobials to prevent UTI;
  3. * Psychologic or psychiatric conditions influencing the ability to follow instructions;
  4. * Use of oral or IV antibiotics within the past 2 weeks;
  5. * Sexual activity within the previous 72 hours;
  6. * Participation in another study with which results could be confounded.

Contacts and Locations

Study Contact

Amanda K Rounds, PhD
CONTACT
202-877-1591
Amanda.K.Rounds@medstar.net
Inger H Ljungberg
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 Date2020-01-10
Study Completion Date2025-09

Study Record Updates

Study Start Date2020-01-10
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Indwelling catheter
  • Foley catheter
  • Suprapubic Catheter

Additional Relevant MeSH Terms

  • Neurogenic Bladder