Consumer Evaluation of an Investigational Intermittent Catheter
14 luglio 2026 aggiornato da: Hollister Incorporated
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Illinois
-
Libertyville, Illinois, Stati Uniti, 60048
- Reclutamento
- Hollister Incorporated
-
Contatto:
- Hollister Incorporated
- Numero di telefono: (847) 680-1000
- Email: researchstudy@hollister.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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:
- 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.
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:
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Investigational Catheter
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.
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An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use
Lasso di tempo: 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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Overall Ease of Use of the Catheter
Lasso di tempo: 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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ease of Advancing the Catheter Through the Protective Tip Into the Urethra
Lasso di tempo: 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, 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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ease of Advancing the Catheter Through the Urethra to the Bladder
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Bladder Drainage and Bladder Emptying
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Worry That the Catheter Does Not Fully Empty the Bladder
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
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Occurrence of Urine Flow Restarting Before Complete Catheter Removal
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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Participant-reported occurrence of urine starting to flow again before the catheter was completely removed from the urethra/body.
Assessed as Yes or No.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Occurrence of Pausing to Allow Remaining Urine to Drain Through the Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
Participant-reported occurrence of pausing to allow remaining urine to drain through the catheter during removal.
Assessed as Yes or No.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Actions Taken to Help Remaining Urine Drain Through the Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ease of Withdrawing the Catheter From the Urethra
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ability to Insert the Catheter Without Contaminating or Touching the Portion That Enters the Body
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ability of the Catheter to Support the Recommended Catheterization Schedule
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Occurrence of Discomfort During Catheter Insertion
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Type of Discomfort During Catheter Insertion
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Frequency of Discomfort During Catheter Insertion
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Occurrence of Coughing or Deep Breathing to Assist Catheter Insertion Into the Bladder
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
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Occurrence of Turning or Twisting the Catheter During Advancement Through the Urethra
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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Participant-reported occurrence of turning or twisting the catheter during advancement through the urethra.
Assessed as Yes or No.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Actions Taken During Catheter Insertion
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Correct Orientation of the Funnel Notch Before Insertion Among Participants Using a Curved-Tip Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
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Occurrence of Turning the Curved-Tip Catheter During Advancement Into the Bladder
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Burden Associated With Orienting or Turning a Curved-Tip Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Difficulty Pushing the Catheter Through the Urethra Into the Bladder
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Occurrence of Discomfort During Bladder Drainage
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
|
Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Frequency of Discomfort During Bladder Drainage
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
|
Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Discomfort Symptoms During Bladder Drainage
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Occurrence of Discomfort During Catheter Removal
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Frequency of Discomfort During Catheter Removal
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Discomfort Symptoms During Catheter Removal
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
|
Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Comfort Using the Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Confidence That the Catheter Will Slide in Comfortably With Each Use
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
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Participant-Reported Confidence That the Catheter Will Slide in Easily With Each Use
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Confidence That the Catheter Allows the Bladder to Empty Fully
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
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Participant-Reported Confidence in Successfully Using the Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
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Time to Participant-Reported Confidence in Using the Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ability of the Catheter to Support Confidence During Use
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Confidence When the Catheter Was Inserted
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Ability of the Catheter to Help the Participant Feel Confident When Used
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
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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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Overall Satisfaction With the Catheter
Lasso di tempo: Through completion of both catheter-use periods, approximately 6 to 20 days
|
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.
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Through completion of both catheter-use periods, approximately 6 to 20 days
|
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Participant-Reported Bladder Emptying Time With the Investigational Catheter Compared With the Participant's Current Intermittent Catheter
Lasso di tempo: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
|
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.
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At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
|
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Participant-Reported Advancement Performance of the Investigational Catheter Compared With the Participant's Current Intermittent Catheter
Lasso di tempo: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
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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.
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At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
|
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Participant-Reported Likelihood of Using the Investigational Catheter if Commercially Available in the Participant's Usual Type and Package
Lasso di tempo: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
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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.
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At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
|
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Participant-Reported Overall Catheter Preference Between the Investigational Catheter and the Participant's Current Intermittent Catheter
Lasso di tempo: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
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Participant-reported overall preference between the investigational catheter and the participant's current intermittent catheter, assessed by categorical response indicating preferred catheter.
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At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Jessica Simmons, Hollister Incorporated
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
9 luglio 2026
Completamento primario (Stimato)
1 ottobre 2026
Completamento dello studio (Stimato)
1 ottobre 2026
Date di iscrizione allo studio
Primo inviato
9 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 luglio 2026
Primo Inserito (Effettivo)
20 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattie urogenitali maschili
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Disturbi della minzione
- Malattie della vescica urinaria
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Ritenzione urinaria
- Vescica urinaria, neurogena
Altri numeri di identificazione dello studio
- 6049-CONT
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .