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Consumer Evaluation of an Investigational Intermittent Catheter

14. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Overall Ease of Use of the Catheter
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
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
Zeitfenster: 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.
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
Zeitfenster: 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, 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Bladder Drainage and Bladder Emptying
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Worry That the Catheter Does Not Fully Empty the Bladder
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Urine Flow Restarting Before Complete Catheter Removal
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-reported occurrence of urine starting to flow again before the catheter was completely removed from the urethra/body. Assessed as Yes or No.
Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Pausing to Allow Remaining Urine to Drain Through the Catheter
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken to Help Remaining Urine Drain Through the Catheter
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Withdrawing the Catheter From the Urethra
Zeitfenster: 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.
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
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support the Recommended Catheterization Schedule
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Insertion
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Type of Discomfort During Catheter Insertion
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Insertion
Zeitfenster: 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.
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
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning or Twisting the Catheter During Advancement Through the Urethra
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-reported occurrence of turning or twisting the catheter during advancement through the urethra. Assessed as Yes or No.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken During Catheter Insertion
Zeitfenster: 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.
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
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning the Curved-Tip Catheter During Advancement Into the Bladder
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Burden Associated With Orienting or Turning a Curved-Tip Catheter
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Difficulty Pushing the Catheter Through the Urethra Into the Bladder
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Bladder Drainage
Zeitfenster: 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
Frequency of Discomfort During Bladder Drainage
Zeitfenster: 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
Participant-Reported Discomfort Symptoms During Bladder Drainage
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Removal
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Removal
Zeitfenster: 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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Discomfort Symptoms During Catheter Removal
Zeitfenster: 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
Participant-Reported Comfort Using the Catheter
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
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
Zeitfenster: 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.
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
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Allows the Bladder to Empty Fully
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence in Successfully Using the Catheter
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Time to Participant-Reported Confidence in Using the Catheter
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support Confidence During Use
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence When the Catheter Was Inserted
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
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
Zeitfenster: Through completion of both catheter-use periods, approximately 6 to 20 days
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.
Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Overall Satisfaction With the Catheter
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
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.
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
Zeitfenster: 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 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.
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
Zeitfenster: At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-reported overall preference between the investigational catheter and the participant's current intermittent catheter, assessed by categorical response indicating preferred catheter.
At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hollister Incorporated

Ermittler

  • Hauptermittler: Jessica Simmons, Hollister Incorporated

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Juli 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2026

Studienabschluss (Geschätzt)

1. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

9. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juli 2026

Zuerst gepostet (Tatsächlich)

20. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 6049-CONT

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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