Consumer Evaluation of an Investigational Intermittent Catheter

This study is looking for men who use intermittent catheters (thin, flexible tubes used to drain the bladder) to test a new investigational intermittent urethral urinary catheter. You would use this new catheter and give feedback on how easy it is to use, how comfortable it feels, and how well it drains your bladder. Researchers will also track any health changes or side effects you experience. The goal is to understand how safe and effective the investigational catheter is compared to the hydrophilic intermittent catheter you currently use. This study is open to men in the USA, at least 22 years old, who self-catheterize at least 3 times a day and have been using a specific type of hydrophilic intermittent catheter for at least one month.

Study design: This is a single-arm study, meaning all participants will receive the investigational catheter. About 50 men will participate.
What's involved: You will first use 30 of your usual catheters, then 30 of the study catheters. During both periods, you will complete daily questionnaires and evaluation forms for approximately 6 to 20 days.
Compensation: Not stated in the trial record.
Follow-up: You will be followed through the completion of both catheter-use periods, which is approximately 6 to 20 days.

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Consumer Evaluation of an Investigational Intermittent Catheter

Recruiting

NAAges 22+InterventionalTreatment

Hollister Incorporated

~50 participants

Updated 2026-07-20 on ClinicalTrials.gov

What's tested:An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use

Measured over Through completion of both catheter-use periods, approximately 6 to 20 days

+1 more outcome measured

Conditions

Urinary Retention

Neurogenic Bladder

Where it's being run

1 sites across 1 states

Illinois1

Study leadership

Jessica Simmons · PRINCIPAL_INVESTIGATOR · Hollister Incorporated

Who to contact

Hollister Incorporated

[email protected]

(847) 680-1000

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

is living in the USA

is male

is at least 22 years of age

can speak, read, and write in English

is self-catheterizing 3 or more times a day

has been performing unassisted, self-catheterizations, with a Hydrophilic IC, for at least 1 month

currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below:

is willing and able to follow the study protocol procedures including completing online questionnaires as demonstrated by signing the Informed Consent

is willing to switch from their current, typical intermittent catheter to the study-provided study products (e.g., study catheters) during the latter portion of the study

is willing to provide permission via the study informed consent and HIPAA Authorization Form for study staff to contact prescribing healthcare provider for a copy of their active prescription. Alternatively subject can opt to provide study staff with their active prescription.

Exclusion

is currently receiving chemotherapy, has received chemotherapy within the past 30 days, or is scheduled to receive chemotherapy during the study (i.e., in the next 34 days)

is currently undergoing, has previously underwent, or is planning to undergo radiation therapy to the bladder, prostate, or rectum during the study (i.e., in the next 34 days)

is currently using one or more of the following oral or injectable steroid therapies for 30 days or more:

currently has urinary tract infection (UTI) symptoms or has been diagnosed with a UTI by a healthcare provider in the last 2 weeks

has a retracted penis

has skin irritation or lesions (sores) on the penis

Performs non-urethral catheterization

Has participated in a study involving actual use of a study urethral IC (i.e. inserting/removing) within the last 30 days

Is currently an employee of Hollister Incorporated or any other intermittent catheter manufacturer.

What this trial measures

Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter UseThrough completion of both catheter-use periods, approximately 6 to 20 days
Number and nature of participant-reported health changes and adverse events collected during both the control-catheter period and the study-catheter period. Safety events will be categorized by incidence, severity, and relatedness.
Participant-Reported Overall Ease of Use of the CatheterThrough completion of both catheter-use periods, approximately 6 to 20 days
Participant-reported overall ease of use of the catheter, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier overall use.

Trialytics