An interventional study of An intermittent urethral urinary catheter with a tip, tube and drainage eyelets in Urinary Retention and Neurogenic Bladder, sponsored by Hollister Incorporated. Recruiting at 1 site in United States. Open to male participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Hollister Incorporated · Not applicable, Interventional, and Treatment
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.
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.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →Hollister Incorporated is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below:
Exclusion Criteria:
is currently using one or more of the following oral or injectable therapies for 30 days or more:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
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 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.
Time frame: Through completion of both catheter-use periods, approximately 6 to 20 days
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 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.
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
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 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.
Time frame: 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.
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
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.
Time frame: 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.
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
Participant-reported occurrence of pausing to allow remaining urine to drain through the catheter during removal. Assessed as Yes or No.
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
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
Participant-reported occurrence of turning or twisting the catheter during advancement through the urethra. Assessed as Yes or No.
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Plan to share: 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
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Oct 2026, 3 months after the start.
Of 82 interventional studies with no phase under Urinary Retention, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 3 months is below that.
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Hollister Incorporated