BridgeMD
New treatment option for Urinary Retention
Official title Consumer Evaluation of an Investigational Intermittent Catheter
ClinicalTrials.gov ID: NCT07714694
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, men only
You may be able to join if
- 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
You likely can't join if
- is currently receiving chemotherapy, has received chemotherapy within the past 30 days, or is scheduled to receive chemotherapy during the study...
- is currently undergoing, has previously underwent, or is planning to undergo radiation therapy to the bladder, prostate, or rectum during the study...
- is currently using one or more of the following oral or injectable steroid therapies for 30 days or more:
- Acthar Gel
- corticotropin
- Agamree
See the full eligibility criteria
Who can 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
- 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...
What rules you out
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Libertyville, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Libertyville, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.