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New catheter design aims to make Self-Catheterization easier and more comfortable

NCT ID NCT07714694

Symptom relief Sponsor: Hollister Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests a new type of intermittent catheter designed for people with urinary retention or neurogenic bladder who need to self-catheterize several times a day. Participants will use the investigational catheter and compare it to their usual product, providing feedback on ease of insertion, comfort, bladder drainage, and overall satisfaction. The goal is to see if the new catheter is safe, easy to use, and preferred over existing options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
What this could lead to
If successful, this catheter could offer a more comfortable and easier-to-use option for people who need to self-catheterize multiple times a day.
What could go wrong
This is a small, early-stage study focused on user feedback and initial safety, so results may not apply to all users or guarantee long-term benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. Hollister Incorporated VaPro Pocket Nelaton Tip (clear protective tip) (SKU 70144) 2. Hollister Incorporated VaPro Pocket Coude (blue protective tip) (SKU 77144) 3. Hollister Incorporated VaPro Coude (blue protective tip) (SKU 73144) 4. Hollister Incorporated VaPro Plus Nelaton (clear protective tip) (SKU 74144) 5. Hollister Incorporated VaPro Plus Pocket Nelaton (clear protective tip) (SKU 71144) 6. Hollister Incorporated Onli Nelaton (SKU: 82144-30) 7. Hollister Incorporated Onli Coudé (SKU: 85144) 8. Wellspect LoFric Origo Nelaton (SKU: 443 14 40) 9. Wellspect LoFric Origo Tiemann/Coudé (SKU: 444 14 40) 10. Wellspect LoFric Origo Flexible Coudé with protective sleeve (SKU: 449 14 40) 11. Wellspect LoFric Origo Flexible Coudé with insertion grip (SKU: 447 14 40) 12. Coloplast SpeediCath Standard Male (SKU: 28414) 13. Coloplast SpeediCath Male Coudé Tip (SKU: 28494) 14. Coloplast SpeediCath Flex Coudé Pro (SKU: 20014) 15. Convatec GentleCath Glide Male Straight Tip (SKU: 421567) 16. Convatec GentleCath Glide Male Tiemann Tip (SKU: 421910) 17. Convatec GentleCath Air Male Straight Tip (SKU:510690) 18. Convatec GentleCath Air Male Coude Tip (SKU:510696) 19. Convatec GentleCath Hydrophilic, 14FR, Straight (SKU: 508996) 20. Convatec GentleCath Hydrophilic, 14FR, Coude (SKU: 509001) 21. Convatec Cure - Hydrophilic Cure Catheter Straight Tip (SKU: HM14) 22. Convatec Cure - Hydrophilic Cure Catheter Coudé Tip (SKU: HM14C) 23. Bard - Magic3® Go Male, 14FR, Straight (SKU:53814G) 24. Bard - Magic3® Go Male, 14FR, Coude (SKU:50814G) 25. Bard - Magic3®, 14FR, Straight (SKU: 53614G) 26. 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. Exclusion Criteria: * 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: 1. Acthar Gel 2. corticotropin 3. Agamree 4. vamorolone 5. budesonide 6. Cortef 7. hydrocortisone 8. Cortrophin Gel 9. corticotrophin 10. dexamethasone 11. deflazacort 12. prednisone 13. Emflaza 14. Eohilia 15. fludrocortisone 16. Jaythari 17. Orapred ODT 18. prednisolone 19. Pyquvi 20. Rayos 21. Tarpeyo 22. 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.

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Conditions

The condition(s) this trial relates to.

Urinary Bladder, Neurogenic Urinary Retention

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurogenic bladder Urinary retention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hollister Incorporated

    RECRUITING

    Libertyville, Illinois, 60048, United States

    Contact Email: •••••@•••••

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