Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05785858
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FLUME Catheter Comfort Study
Sponsor:
The Flume Catheter Company Ltd
Organization:
Study Overview
Official Title:
FLUME Catheter Comfort Study
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Background:
Urethral catheters function to drain the urinary bladder when medically indicated or when individuals are unable to empty their bladder by other means. This potential benefit of urinary drainage is balanced by substantial risks of the presence of a urinary catheter in the bladder. While much of the current literature focuses on Catheter Associated Urinary Tract Infections (CAUTI), patients experience substantial pain and discomfort as well. For example, in a cohort of 2000 participants, 50% reported pain or discomfort from the catheter, 20% experienced bladder spasms, and 40% experienced restricted activity1. These non-infectious complications create a substantial burden and decrement in quality of life when a catheter is required.
Rationale:
The Flume catheter is a commercially available catheter (FDA 510(k) cleared) with an innovative catheter design (figure 2). The traditional Foley catheter design includes a protruding tip with drainage holes, which clinically creates edema and disruption of the urothelial lining of the bladder. This protruding tip may also 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 this change in design, it is plausible that patients may experience less irritation of the urinary bladder, with a concomitant decrease in pain, discomfort, and bladder spasms. The study described herein seeks to compare patient comfort with a traditional catheter vs a Flume catheter.
Flume Catheter Comfort Study is a prospective, observational cohort study comparing patient-reported measures of comfort between the innovative Flume catheter design and the traditional catheter typically used by study participants. Only chronic catheter participants who receive catheter exchanges every 30 days are eligible to participate. As such, a pre-post study design (baseline and 30 day follow up) will allow for individual patients to act as their own control group pre- and post-Flume catheter insertion.
Urethral catheters function to drain the urinary bladder when medically indicated or when individuals are unable to empty their bladder by other means. This potential benefit of urinary drainage is balanced by substantial risks of the presence of a urinary catheter in the bladder. While much of the current literature focuses on Catheter Associated Urinary Tract Infections (CAUTI), patients experience substantial pain and discomfort as well. For example, in a cohort of 2000 participants, 50% reported pain or discomfort from the catheter, 20% experienced bladder spasms, and 40% experienced restricted activity1. These non-infectious complications create a substantial burden and decrement in quality of life when a catheter is required.
Rationale:
The Flume catheter is a commercially available catheter (FDA 510(k) cleared) with an innovative catheter design (figure 2). The traditional Foley catheter design includes a protruding tip with drainage holes, which clinically creates edema and disruption of the urothelial lining of the bladder. This protruding tip may also 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 this change in design, it is plausible that patients may experience less irritation of the urinary bladder, with a concomitant decrease in pain, discomfort, and bladder spasms. The study described herein seeks to compare patient comfort with a traditional catheter vs a Flume catheter.
Flume Catheter Comfort Study is a prospective, observational cohort study comparing patient-reported measures of comfort between the innovative Flume catheter design and the traditional catheter typically used by study participants. Only chronic catheter participants who receive catheter exchanges every 30 days are eligible to participate. As such, a pre-post study design (baseline and 30 day follow up) will allow for individual patients to act as their own control group pre- and post-Flume catheter insertion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: