Recruiting

FLUME

Sponsor:

The Flume Catheter Company Ltd

Code:

NCT05785858

Conditions

Urinary Catheters

Bladder Pain and Discomfort

Urine Leakage

Bladder Spasm

Chronic Urinary Catheter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Urinary Catheters

Bladder Pain and Discomfort

Urine Leakage

Bladder Spasm

Chronic Urinary Catheter

Study ID

NCT05785858

Start date

Jun 1, 2023

Status verified date

Sep, 2023

Completion date

Mar 30, 2024

Anticipated

Primary completion date

Mar 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Document informed consent
2. Age ≥ 18 years at time of study entry
3. Indwelling urethral catheter use for at least the 3 months prior to study enrollment.
4. Able to read, write, and speak English

Exclusion Criteria:

1. Indwelling Foley catheter user for shorter than 3 months
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. Unable to read/write English at a 6th grade level
4. Neurologic diagnoses which could decrease/impair bladder sensation (e.g., spinal cord injury, multiple sclerosis)
5. History of bladder augmentation or urinary diversion
6. Existing catheter related genital adverse effects (e.g., meatal erosion)
7. Current use of indwelling catheter larger than 18 Fr in size
8. Otherwise unable to participate in or complete study procedures, in the opinion of the principal investigator.

Study Design

Enrollment

41 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in patient reported outcomes--Total Neurogenic Bladder Symptom Score Short Form [ Time Frame: Baseline and 30 day follow-up ]

Central Contacts and Locations

Central contacts

Tullika Garg, MD

717-531-0003tgarg@pennstatehealth.psu.edu

Halle Becker

717-531-1053hbecker3@pennstatehealth.psu.edu

Locations

Penn State Department of Urology

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Halle Becker

717-531-1053hbecker3@pennstatehealth.psu.edu

Principal Investigator:

Tullika Garg, MD

More Information

Sponsor

The Flume Catheter Company Ltd

Last update posted

Sep 13, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Flume Catheter Company Ltd on 2023-09-13.