RECRUITING

Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life

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 goal of this clinical trial is to evaluate the feasibility and tolerability of 0.05% Chlorhexidine Gluconate (CGH) bladder instillations in an outpatient setting at the time of suprapubic catheter (SPC) exchange in patients with history of recurrent urinary tract infections (UTI). The main questions are: 1. is instillation of 150mL of CGH for five-minute duration at the time of SPC exchange feasible in an outpatient setting and tolerable for patients. 2. does this protocol decrease the rate of unplanned health care visits and improve patient quality of life. Patients will undergo the treatment protocol during their routine suprapubic catheter exchanges.

Official Title

Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters

Quick Facts

Study Start:2024-04-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06163469

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. * Indwelling suprapubic catheter with insertion date at least 1 year prior to study enrollment date.
  2. * History of urinary tract infections, treated for at least 1 positive urine culture in last 6 months
  1. * Current radiographic evidence of urolithiasis
  2. * History of vesicoureteral reflux
  3. * History of renal transplantation
  4. * History of bladder augmentation
  5. * Inability to stop use of other rUTI prophylaxis treatments for the duration of their trial enrollment
  6. * Life expectancy of less than 12 months prior to consent.
  7. * Known hypersensitivity or allergy to chlorhexidine.
  8. * Women who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Joshua Sterling, MD, MSc
CONTACT
203-737-3619
joshua.sterling@yale.edu

Principal Investigator

Joshua Sterling, MD, MSc
PRINCIPAL_INVESTIGATOR
Yale School of Medicine

Study Locations (Sites)

Yale New Haven Health
New Haven, Connecticut, 06519
United States

Collaborators and Investigators

Sponsor: Yale University

  • Joshua Sterling, MD, MSc, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

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 Date2024-04-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • recurrent UTI
  • bladder irrigation

Additional Relevant MeSH Terms

  • Neurogenic Bladder
  • Urinary Retention