Urinary RetentionNCT07714694
Consumer Evaluation of an Investigational Intermittent Catheter
A study testing An intermittent urethral urinary catheter with a tip, tube and drainage eyelets in people with Urinary Retention and Neurogenic Bladder, run by Hollister Incorporated at 1 site in United States.
Trial summary
This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Read more about this study
- Who is it for?
- Ages 22 years and older, men only
- Conditions the study is for
- Urinary Retention, Neurogenic Bladder
- What is being tested?
- An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 36Show fewer
- currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below:
- Hollister Incorporated VaPro Pocket Nelaton Tip (clear protective tip) (SKU 70144)
- Hollister Incorporated VaPro Pocket Coude (blue protective tip) (SKU 77144)
- Hollister Incorporated VaPro Coude (blue protective tip) (SKU 73144)
- Hollister Incorporated VaPro Plus Nelaton (clear protective tip) (SKU 74144)
- Hollister Incorporated VaPro Plus Pocket Nelaton (clear protective tip) (SKU 71144)
- Hollister Incorporated Onli Nelaton (SKU: 82144-30)
- Hollister Incorporated Onli Coudé (SKU: 85144)
- Wellspect LoFric Origo Nelaton (SKU: 443 14 40)
- Wellspect LoFric Origo Tiemann/Coudé (SKU: 444 14 40)
- Wellspect LoFric Origo Flexible Coudé with protective sleeve (SKU: 449 14 40)
- Wellspect LoFric Origo Flexible Coudé with insertion grip (SKU: 447 14 40)
- Coloplast SpeediCath Standard Male (SKU: 28414)
- Coloplast SpeediCath Male Coudé Tip (SKU: 28494)
- Coloplast SpeediCath Flex Coudé Pro (SKU: 20014)
- Convatec GentleCath Glide Male Straight Tip (SKU: 421567)
- Convatec GentleCath Glide Male Tiemann Tip (SKU: 421910)
- Convatec GentleCath Air Male Straight Tip (SKU:510690)
- Convatec GentleCath Air Male Coude Tip (SKU:510696)
- Convatec GentleCath Hydrophilic, 14FR, Straight (SKU: 508996)
- Convatec GentleCath Hydrophilic, 14FR, Coude (SKU: 509001)
- Convatec Cure - Hydrophilic Cure Catheter Straight Tip (SKU: HM14)
- Convatec Cure - Hydrophilic Cure Catheter Coudé Tip (SKU: HM14C)
- Bard - Magic3® Go Male, 14FR, Straight (SKU:53814G)
- Bard - Magic3® Go Male, 14FR, Coude (SKU:50814G)
- Bard - Magic3®, 14FR, Straight (SKU: 53614G)
- Bard - Magic3®, 14FR, Straight (SKU: 53614) aa. Bard - Magic3®, 14FR, Coude (SKU: 50614)
- 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.
Who cannot join
- 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:
- Acthar Gel
- corticotropin
- Agamree
Show all 31Show fewer
- vamorolone
- budesonide
- Cortef
- hydrocortisone
- Cortrophin Gel
- corticotrophin
- dexamethasone
- deflazacort
- prednisone
- Emflaza
- Eohilia
- fludrocortisone
- Jaythari
- Orapred ODT
- prednisolone
- Pyquvi
- Rayos
- Tarpeyo
- Uceris
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hollister Incorporated
Libertyville, Illinois, 60048
Hollister Incorporated, (847) 680-1000, researchstudy@hollister.com
About this study
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.
Read the detailed description
This is a prospective, single-arm, fixed-sequence, within-participant clinical evaluation of an investigational intermittent catheter. Eligible adult male participants in the United States who currently use hydrophilic intermittent catheters will first use 30 of their usual catheters and then 30 study catheters. During both catheter-use periods, participants will complete daily questionnaires regarding catheter use and health changes and will complete evaluation forms assessing ease of use, catheter performance, comfort, confidence, satisfaction, and comparative preference. Safety will be evaluated through reported health changes and adverse events. The study is intended to provide descriptive information regarding the initial safety, usability, and performance of the investigational catheter relative to participants' current intermittent catheter products.
- Conditions
- Urinary Retention, Neurogenic Bladder
- Being tested
- An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
- Medical subject headings
- Urinary Retention, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An intermittent urethral urinary catheter with a tip, tube and drainage eyeletsDevice
An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
| Study group | Role | What they receive |
|---|---|---|
| Investigational Catheter | Experimental | Participants will first use 30 of their usual intermittent catheters and then switch to 30 study catheters in a fixed-sequence, within-participant design. All participants receive the same study catheter; responses from the usual-catheter period provide within-participant control context. Receives: Device: An intermittent urethral urinary catheter with a tip, tube and drainage eyelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Secondary outcomes (42)
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.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Bladder Drainage and Bladder Emptying
Participant-reported ease of draining the bladder with 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 bladder drainage and emptying.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Worry That the Catheter Does Not Fully Empty the Bladder
Assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Higher scores indicate less worry and a more favorable response.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Urine Flow Restarting Before Complete Catheter Removal
Participant-reported occurrence of urine starting to flow again before the catheter was completely removed from the urethra/body. Assessed as Yes or No.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Pausing to Allow Remaining Urine to Drain Through the Catheter
Participant-reported occurrence of pausing to allow remaining urine to drain through the catheter during removal. Assessed as Yes or No.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken to Help Remaining Urine Drain Through the Catheter
Participant-reported actions taken to help remaining urine drain through the catheter, assessed as a check-all-that-apply item. Each response option will be summarized separately by number of participants selecting it.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Withdrawing the Catheter From the Urethra
Participant-reported ease of withdrawing the catheter from 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 withdrawal.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability to Insert the Catheter Without Contaminating or Touching the Portion That Enters the Body
Participant-reported agreement with the statement that the catheter can be inserted without contaminating or touching the portion that enters the body, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate a more favorable response.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support the Recommended Catheterization Schedule
Participant-reported agreement with the statement that the catheter helps the participant follow the catheterization schedule recommended by a doctor or nurse, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate a more favorable response.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Insertion
Participant-reported discomfort during catheter insertion, assessed on a 5-point ordinal scale coded 1 to 5: 1 = No discomfort, 2 = A little discomfort, 3 = Some discomfort, 4 = A lot of discomfort, and 5 = Extreme discomfort. Higher scores indicate worse discomfort.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Type of Discomfort During Catheter Insertion
Participant-reported type of discomfort experienced during catheter insertion, assessed as a check-all-that-apply item. Each symptom category will be summarized separately by number of participants selecting it.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Insertion
Participant-reported frequency of discomfort during catheter insertion, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Always, 2 = Often, 3 = Sometimes, and 4 = Rarely. Lower scores indicate more frequent discomfort.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Coughing or Deep Breathing to Assist Catheter Insertion Into the Bladder
Participant-reported occurrence of coughing and/or taking a deep breath to help the catheter enter the bladder during insertion. Assessed by categorical response: Cough, Deep Breath, Both, or Neither.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning or Twisting the Catheter During Advancement Through the Urethra
Participant-reported occurrence of turning or twisting the catheter during advancement through the urethra. Assessed as Yes or No.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken During Catheter Insertion
Participant-reported actions taken during catheter insertion, assessed as a check-all-that-apply item. Each response option will be summarized separately by number of participants selecting it.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Correct Orientation of the Funnel Notch Before Insertion Among Participants Using a Curved-Tip Catheter
Among participants using a curved-tip catheter, participant-reported frequency of lining up the notch on the funnel so the tip pointed up before insertion, assessed by ordinal categorical response ranging from all the time to not at all, plus categories for not knowing about the notch or not using a coudé catheter.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning the Curved-Tip Catheter During Advancement Into the Bladder
Among participants using a curved-tip catheter, participant-reported occurrence/frequency of turning the catheter during advancement into the bladder, assessed by ordinal categorical response ranging from all the time to not at all.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Burden Associated With Orienting or Turning a Curved-Tip Catheter
Participant-reported burden associated with lining up the funnel notch and/or turning a curved-tip catheter during insertion, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Much more burdensome, 2 = Moderately more burdensome, 3 = A little more burdensome, and 4 = Not more burdensome. Lower scores indicate greater burden.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Difficulty Pushing the Catheter Through the Urethra Into the Bladder
Participant-reported difficulty/ease of pushing the catheter through the urethra into 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 passage.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Bladder Drainage
Participant-reported discomfort during bladder drainage, assessed on a 5-point ordinal scale coded 1 to 5: 1 = No discomfort, 2 = A little discomfort, 3 = Some discomfort, 4 = A lot of discomfort, and 5 = Extreme discomfort. Higher scores indicate worse discomfort.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Bladder Drainage
Participant-reported frequency of discomfort during bladder drainage, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Always, 2 = Often, 3 = Sometimes, and 4 = Rarely. Lower scores indicate more frequent discomfort.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Discomfort Symptoms During Bladder Drainage
Participant-reported discomfort symptoms during bladder drainage, assessed as a check-all-that-apply item. Each symptom category will be summarized separately by number of participants selecting it.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Removal
Participant-reported discomfort during catheter removal, assessed on a 5-point ordinal scale coded 1 to 5: 1 = No discomfort, 2 = A little discomfort, 3 = Some discomfort, 4 = A lot of discomfort, and 5 = Extreme discomfort. Higher scores indicate worse discomfort.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Removal
Participant-reported frequency of discomfort during catheter removal, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Always, 2 = Often, 3 = Sometimes, and 4 = Rarely. Lower scores indicate more frequent discomfort.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Discomfort Symptoms During Catheter Removal
Participant-reported discomfort symptoms during catheter removal, assessed as a check-all-that-apply item. Each symptom category will be summarized separately by number of participants selecting it.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Comfort Using the Catheter
Participant-reported agreement with the statement "I feel comfortable using the catheter," assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater comfort.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Will Slide in Comfortably With Each Use
Participant-reported agreement with the statement that the catheter will slide in comfortably every time it is used, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Will Slide in Easily With Each Use
Participant-reported agreement with the statement that the catheter will slide in easily every time it is used, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Allows the Bladder to Empty Fully
Participant-reported agreement with the statement that the catheter allows the bladder to empty fully, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence in Successfully Using the Catheter
Participant-reported agreement with the statement "I am confident I can successfully use the catheter," assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Time to Participant-Reported Confidence in Using the Catheter
Participant-reported time required to feel confident using the catheter, assessed on an 11-category ordinal scale: Less than 1 day, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 1 week to 10 days, More than 10 days, or I still do not feel confident. Lower categories indicate earlier confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support Confidence During Use
Participant-reported agreement with the statement that the catheter allows the participant to feel confident, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence When the Catheter Was Inserted
Participant-reported confidence when the catheter was inserted, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Very confident, 2 = Somewhat confident, 3 = A little confident, and 4 = Not confident. Lower scores indicate greater confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Help the Participant Feel Confident When Used
Participant-reported agreement with the statement that the catheter helps the participant feel confident when used, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Overall Satisfaction With the Catheter
Participant-reported overall satisfaction with the catheter, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, and 5 = Very dissatisfied. Lower scores indicate greater satisfaction.
Measured: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Bladder Emptying Time With the Investigational Catheter Compared With the Participant's Current Intermittent Catheter
Participant-reported comparison of how long it took to empty the bladder with the investigational catheter relative to the participant's current intermittent catheter. Assessed by categorical comparative response.
Measured: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-Reported Advancement Performance of the Investigational Catheter Compared With the Participant's Current Intermittent Catheter
Participant-reported comparison of how the investigational catheter performed when advancing through the urethra into the bladder to drain urine relative to the participant's current intermittent catheter. Assessed by categorical comparative response.
Measured: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-Reported Likelihood of Using the Investigational Catheter if Commercially Available in the Participant's Usual Type and Package
Participant-reported likelihood of using the investigational catheter if it were commercially available in the participant's usual type and package, assessed by ordinal categorical response. More favorable responses indicate greater likelihood of use.
Measured: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-Reported Overall Catheter Preference Between the Investigational Catheter and the Participant's Current Intermittent Catheter
Participant-reported overall preference between the investigational catheter and the participant's current intermittent catheter, assessed by categorical response indicating preferred catheter.
Measured: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start9 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will first use 30 of their usual intermittent catheters and then will switch to 30 study catheters in a fixed-sequence, within-participant design. The study has one experimental arm because all participants receive the same study catheter; each participant serves as his own control through comparison of assessments made after the usual-catheter period and the study-catheter period.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Simmons, Principal investigator, Hollister Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714694
- Sponsor's protocol ID
- 6049-CONT
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Will individual participant data be available (including data dictionaries)? No What data in particular will be shared? Not available What other documents will be available? Not available When will data be available (start and end dates)? N/A With whom? N/A For what types of analyses? N/A By what mechanism will data be made available? N/A
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Evaluation of an Investigational Intermittent Catheter
- ClinicalTrials.gov ID
- NCT07714694
- Acronym / sponsor ID
- 6049-CONT
- Conditions
- Urinary Retention, Neurogenic Bladder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Jul 2026 (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.
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.
Detailed description
This is a prospective, single-arm, fixed-sequence, within-participant clinical evaluation of an investigational intermittent catheter. Eligible adult male participants in the United States who currently use hydrophilic intermittent catheters will first use 30 of their usual catheters and then 30 study catheters. During both catheter-use periods, participants will complete daily questionnaires regarding catheter use and health changes and will complete evaluation forms assessing ease of use, catheter performance, comfort, confidence, satisfaction, and comparative preference. Safety will be evaluated through reported health changes and adverse events. The study is intended to provide descriptive information regarding the initial safety, usability, and performance of the investigational catheter relative to participants' current intermittent catheter products.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will first use 30 of their usual intermittent catheters and then will switch to 30 study catheters in a fixed-sequence, within-participant design. The study has one experimental arm because all participants receive the same study catheter; each participant serves as his own control through comparison of assessments made after the usual-catheter period and the study-catheter period.
| Arm | Type | Receives |
|---|---|---|
| Investigational Catheter | Experimental | Device: An intermittent urethral urinary catheter with a tip, tube and drainage eyeletsParticipants will first use 30 of their usual intermittent catheters and then switch to 30 study catheters in a fixed-sequence, within-participant design. All participants receive the same study catheter; responses from the usual-catheter period provide within-participant control context. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An intermittent urethral urinary catheter with a tip, tube and drainage eyeletsAn intermittent urethral urinary catheter with a tip, tube and drainage eyelets | Device | Investigational Catheter |
Primary outcome
Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use
Time frame: Through 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 Catheter
Time frame: Through 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.
42 secondary outcomes
Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Advancing the Catheter Through the Protective Tip Into the Urethra
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Advancing the Catheter Through the Urethra to the Bladder
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Bladder Drainage and Bladder Emptying
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Worry That the Catheter Does Not Fully Empty the Bladder
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Urine Flow Restarting Before Complete Catheter Removal
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Pausing to Allow Remaining Urine to Drain Through the Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken to Help Remaining Urine Drain Through the Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Withdrawing the Catheter From the Urethra
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability to Insert the Catheter Without Contaminating or Touching the Portion That Enters the Body
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support the Recommended Catheterization Schedule
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Insertion
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Type of Discomfort During Catheter Insertion
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Insertion
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Coughing or Deep Breathing to Assist Catheter Insertion Into the Bladder
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning or Twisting the Catheter During Advancement Through the Urethra
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken During Catheter Insertion
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Correct Orientation of the Funnel Notch Before Insertion Among Participants Using a Curved-Tip Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning the Curved-Tip Catheter During Advancement Into the Bladder
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Burden Associated With Orienting or Turning a Curved-Tip Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Difficulty Pushing the Catheter Through the Urethra Into the Bladder
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Bladder Drainage
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Bladder Drainage
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Discomfort Symptoms During Bladder Drainage
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Removal
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Removal
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Discomfort Symptoms During Catheter Removal
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Comfort Using the Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Will Slide in Comfortably With Each Use
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Will Slide in Easily With Each Use
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Allows the Bladder to Empty Fully
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence in Successfully Using the Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Time to Participant-Reported Confidence in Using the Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support Confidence During Use
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence When the Catheter Was Inserted
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Help the Participant Feel Confident When Used
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Overall Satisfaction With the Catheter
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Bladder Emptying Time With the Investigational Catheter Compared With the Participant's Current Intermittent Catheter
Time frame: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-Reported Advancement Performance of the Investigational Catheter Compared With the Participant's Current Intermittent Catheter
Time frame: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. Will individual participant data be available (including data dictionaries)? No What data in particular will be shared? Not available What other documents will be available? Not available When will data be available (start and end dates)? N/A With whom? N/A For what types of analyses? N/A By what mechanism will data be made available? N/A
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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.
Jessica Simmons principal investigator
Hollister Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An intermittent urethral urinary catheter with a tip, tube and drainage eyelets in people with Urinary Retention and Neurogenic Bladder, run by Hollister Incorporated 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 36 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use (time frame: Through completion of both catheter-use periods, approximately 6 to 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.