FLUME Catheter Comfort Study

NCT05785858 | Unknown

• 1 other identifier: Pro00111896
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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; Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Change in patient reported outcomes--Total Neurogenic Bladder Symptom Score Short Form

  Patient reported outcomes will be collected and compared at two time points using the validated Neurogenic Bladder Symptom Score short form. Scores for the Total Neurogenic Bladder Symptom Score Short Form can range from 0-28, with 0 being the best and 28 being the worst.

  Baseline and 30 day follow-up

Secondary Outcomes (3)

• Change in patient reported outcomes--Neurogenic Bladder Symptom Score Short Form incontinence domains

  Baseline and 30 day follow-up

• Change in patient reported outcomes--Neurogenic Bladder Symptom Score Short Form quality of life domains

  Baseline and 30 day follow-up

• Change in patient reported outcomes--applicable Genitourinary pain index instrument questions

  Baseline and 30 day follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a clinical indication for exchange of an indwelling (long term) urethral catheter will be screened for participation based on the inclusion and exclusion criteria. Participants will be enrolled at Penn State Medical Center Urology Clinics. We anticipate that the participants enrolled will be representative of the general population presenting to the participating clinic for long-term catheter care. Based on our power calculations for the analysis population, we will assume a 25% dropout rate so we will enroll 41 participants with the expectation only 34 will complete and be eligible to be included in the analysis population.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Flume Catheter Company Ltd: lead
• Duke Clinical Research Institute: collaborator
• Milton S. Hershey Medical Center: collaborator

Study Sites (1)

Penn State Department of Urology

Hershey, Pennsylvania, 17033, United States

RECRUITING

Related Publications (2)

• Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417.

  PMID: 29971436 BACKGROUND

• Mackay A, Sosland R, Tran K, Stewart J, Boone T, Khavari R. Prospective Evaluation of Intradetrusor Injections of OnabotulinumtoxinA in Adults With Spinal Dysraphism. Urology. 2022 Mar;161:146-152. doi: 10.1016/j.urology.2021.09.045. Epub 2021 Dec 8.

  PMID: 34890686 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Charles Scales, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tullika Garg, MD

CONTACT

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

Halle Becker

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: June 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)