RECRUITING

FLUME Catheter Comfort Study

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 Flume catheter is a commercially available (FDA 510(k) cleared) urethral catheter with an innovative catheter design. The traditional Foley catheter design includes a protruding tip with drainage holes. The protruding tip may contribute to patient discomfort, pain and bladder spasms. The Flume catheter is designed such that the balloon envelops the tip on inflation, thus eliminating the protruding catheter tip, while the drainage holes are inset low in the balloon, providing protection to the bladder lining. Based on the change in design, the hypothesis of this observational cohort study is the Flume catheter will have better patient comfort scores (using validated patient reported outcomes measures) when compared to a traditional catheter.

Official Title

FLUME Catheter Comfort Study

Quick Facts

Study Start:2023-06-01
Study Completion:2024-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05785858

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:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Document informed consent
  2. 2. Age ≥ 18 years at time of study entry
  3. 3. Indwelling urethral catheter use for at least the 3 months prior to study enrollment.
  4. 4. Able to read, write, and speak English
  1. 1. Indwelling Foley catheter user for shorter than 3 months
  2. 2. Treatment for a urinary tract infection within 30 days prior to insertion of the Flume catheter, or reporting signs or symptoms of urinary tract infection at the time of catheter change, in the opinion of the treating clinician or site principal investigator.
  3. 3. Unable to read/write English at a 6th grade level
  4. 4. Neurologic diagnoses which could decrease/impair bladder sensation (e.g., spinal cord injury, multiple sclerosis)
  5. 5. History of bladder augmentation or urinary diversion
  6. 6. Existing catheter related genital adverse effects (e.g., meatal erosion)
  7. 7. Current use of indwelling catheter larger than 18 Fr in size
  8. 8. Otherwise unable to participate in or complete study procedures, in the opinion of the principal investigator.

Contacts and Locations

Study Contact

Tullika Garg, MD
CONTACT
717-531-0003
tgarg@pennstatehealth.psu.edu
Halle Becker
CONTACT
717-531-1053
hbecker3@pennstatehealth.psu.edu

Principal Investigator

Charles Scales, MD
PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute

Study Locations (Sites)

Penn State Department of Urology
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: The Flume Catheter Company Ltd

  • Charles Scales, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

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 Date2023-06-01
Study Completion Date2024-03-30

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2024-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Urinary Catheters
  • Bladder Pain and Discomfort
  • Urine Leakage
  • Bladder Spasm
  • Chronic Urinary Catheter
  • Urinary Retention