Urinary CathetersNCT05785858
FLUME Catheter Comfort Study
An observational study of Urinary Catheters and Bladder Pain and Discomfort, run by The Flume Catheter Company Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Catheters, Bladder Pain and Discomfort, Urine Leakage
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Penn State Department of Urology
Hershey, Pennsylvania, 17033
Halle Becker, 717-531-1053, hbecker3@pennstatehealth.psu.edu
Tullika Garg, MD
About this study
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.
Read the 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.
- Conditions
- Urinary Catheters, Bladder Pain and Discomfort, Urine Leakage, Bladder Spasm, Chronic Urinary Catheter, Urinary Retention
- Medical subject headings
- Urinary Retention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 day follow-up
Secondary outcomes (3)
Change in patient reported outcomes--Neurogenic Bladder Symptom Score Short Form incontinence domains
Patient reported outcomes will be collected and compared at two time points using the validated Neurogenic Bladder Symptom Score short form. Scores for the incontinence domain of the Neurogenic Bladder Symptom Score short form can range from 0 to 12, with 0 being the best and 12 being the worst.
Measured: Baseline and 30 day follow-up
Change in patient reported outcomes--Neurogenic Bladder Symptom Score Short Form quality of life domains
Patient reported outcomes will be collected and compared at two time points using the validated Neurogenic Bladder Symptom Score short form. Scores for the quality of life section of the Neurogenic Bladder Symptom Score Short Form domain can range from 0 to 4, with 0 being the best and 4 being the worst.
Measured: Baseline and 30 day follow-up
Change in patient reported outcomes--applicable Genitourinary pain index instrument questions
Patient reported outcomes will be collected and compared at two time points using the applicable portions of the Genitourinary pain index instrument. The Genitourinary pain index instrument scores can range from 0 to 31, with 0 being the best and 31 being the worst
Measured: Baseline and 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jun 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary CathetersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Flume Catheter Company Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, Milton S. Hershey Medical Center
- Responsible party
- Sponsor
- Investigators
- Charles Scales, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785858
- Sponsor's protocol ID
- Pro00111896
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29971436Mackay 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.
PubMed 34890686
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLUME Catheter Comfort Study
- ClinicalTrials.gov ID
- NCT05785858
- Acronym / sponsor ID
- Pro00111896
- Conditions
- Urinary Catheters, Bladder Pain and Discomfort, Urine Leakage, Bladder Spasm, Chronic Urinary Catheter, Urinary Retention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- The Flume Catheter Company LtdIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, Milton S. Hershey Medical Center
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in patient reported outcomes--Total Neurogenic Bladder Symptom Score Short Form
Time frame: Baseline and 30 day follow-up
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.
3 secondary outcomes
Change in patient reported outcomes--Neurogenic Bladder Symptom Score Short Form incontinence domains
Time frame: Baseline and 30 day follow-up
Change in patient reported outcomes--Neurogenic Bladder Symptom Score Short Form quality of life domains
Time frame: Baseline and 30 day follow-up
Change in patient reported outcomes--applicable Genitourinary pain index instrument questions
Time frame: Baseline and 30 day follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 29971436Saint 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.
- Background: PubMed 34890686Mackay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Scales, MD principal investigator
Duke Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Catheters and Bladder Pain and Discomfort, run by The Flume Catheter Company Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tullika Garg, MD (717-531-0003 ext. 322301, tgarg@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported outcomes--Total Neurogenic Bladder Symptom Score Short Form (time frame: Baseline and 30 day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05785858, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.