Consumer Evaluation of an Investigational Intermittent Catheter
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age22+
SponsorHollister Incorporated
About this trial
This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Participants will use the study catheter and provide feedback on their experience, including ease of insertion, advancement through the urethra, bladder drainage, withdrawal, comfort, confidence, satisfaction, and overall ease of use.
Safety will be evaluated through reported health changes and adverse events. Device performance and user experience will be assessed using participant questionnaires and comparisons with the participant's current intermittent catheter, including questions related to catheter handling, comfort during catheterization, perceived ability to empty the bladder, likelihood of future use, and product preference.
The study is intended to generate descriptive information on the initial clinical use of the investigational catheter and to help characterize its safety, usability, comfort, satisfaction, and performance relative to participants' current intermittent catheter products.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
is living in the USA
is male
is at least 22 years of age
can speak, read, and write in English
Disqualifiers
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)
Acthar Gel
corticotropin
Trial design
Design model
Single group
Treatments tested in this trial
An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
DeviceAn intermittent urethral urinary catheter with a tip, tube and drainage eyelets
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Investigational CatheterExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use
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.
Time frame
Through completion of both catheter-use periods, approximately 6 to 20 days2
Participant-Reported Overall Ease of Use of the Catheter
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.
Time frame
Through completion of both catheter-use periods, approximately 6 to 20 daysSecondary outcomes
1
Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening
Participant-reported ease of inserting the protective tip into the urethral opening, 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 insertion. Applicable for the study catheter and usual catheters with a protective tip.
Time frame
Through completion of both catheter-use periods, approximately 6 to 20 days2
Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening
Participant-reported ease of inserting the catheter itself into the urethral opening for usual catheters without a protective tip, 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 insertion.
Time frame
Through completion of both catheter-use periods, approximately 6 to 20 days3
Participant-Reported Ease of Advancing the Catheter Through the Protective Tip Into the Urethra
Participant-reported ease of advancing the catheter through the protective tip into the urethra, 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 advancement.
Time frame
Through completion of both catheter-use periods, approximately 6 to 20 days4
Participant-Reported Ease of Advancing the Catheter Through the Urethra to the Bladder
Participant-reported ease of advancing the catheter through the urethra to the bladder, 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 advancement.
Time frame
Through completion of both catheter-use periods, approximately 6 to 20 daysSponsors and contacts
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Source ClinicalTrials.gov