Consumer Evaluation of an Investigational Intermittent Catheter

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.

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.

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.

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.

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.

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.

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.

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.

Participant-reported occurrence of urine starting to flow again before the catheter was completely removed from the urethra/body. Assessed as Yes or No.

Participant-reported occurrence of pausing to allow remaining urine to drain through the catheter during removal. Assessed as Yes or No.

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.

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.

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.

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.

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.

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.

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.

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.

Participant-reported occurrence of turning or twisting the catheter during advancement through the urethra. Assessed as Yes or No.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Participant-reported overall preference between the investigational catheter and the participant's current intermittent catheter, assessed by categorical response indicating preferred catheter.