Urinary Incontinence
Conditions
Brief summary
The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.
Detailed description
Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management. Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.
Interventions
DEVICECLINY catheter
Subjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age and has full legal capacity 2. Signed informed consent form 3. Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion 4. Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product 5. Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion
Exclusion criteria
1. Participation in any other clinical intervention study during this investigation 2. Previous participation in this investigation 3. Any known allergies towards ingredients in the investigational device 4. Symptoms of UTI at time of inclusion, as judged by the investigator 5. Antibiotic treatment within 2 weeks prior to the Baseline visit (V1) 6. Pregnancy 7. Breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. | Baseline (day 0) and Termination (day 28). | The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 28 days | Number of Adverse Events during the study |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CLINY Reusable Catheter Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | CLINY Reusable Catheter | — |
|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 11.1 | — |
| Height, Continuous | 175.3 Centimeters STANDARD_DEVIATION 10 | — |
| Left hand function, Categorical Do not know | 2 Participants | — |
| Left hand function, Categorical Normal dexterity | 25 Participants | — |
| Left hand function, Categorical Reduced dexterity | 6 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Reason for IC use, Categorical Benign Prostatic Hyperplasia | 4 Participants | — |
| Reason for IC use, Categorical Multiple Sclerosis | 8 Participants | — |
| Reason for IC use, Categorical Other | 6 Participants | — |
| Reason for IC use, Categorical Poor bladder emptying | 11 Participants | — |
| Reason for IC use, Categorical Spinal Cord Injury | 4 Participants | — |
| Region of Enrollment Denmark | 33 participants | — |
| Right hand function, Categorical Normal dexterity | 29 Participants | — |
| Right hand function, Categorical Reduced dexterity | 4 Participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
| Time since starting IC as bladder management method, Continuous (years) | 9.2 years STANDARD_DEVIATION 10.4 | — |
| Urethral Sensitivity, Categorical Impaired | 4 Participants | — |
| Urethral Sensitivity, Categorical None | 5 Participants | — |
| Urethral Sensitivity, Categorical Normal | 24 Participants | — |
| Weight, Continuous | 81.5 Kilograms STANDARD_DEVIATION 17.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 8 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.
The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score)
Time frame: Baseline (day 0) and Termination (day 28).
Population: The full analysis set constituted all subjects enrolled who had been exposed to at least one device, with at least one endpoint recorded (data non-missing).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| CLINY Reusable Catheter | Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. | Termination visit | 56.66 score on a scale |
| CLINY Reusable Catheter | Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. | Baseline visit | 79.09 score on a scale |
Secondary
Adverse Events
Number of Adverse Events during the study
Time frame: 28 days
Population: The full analysis set constituted all subjects enrolled who had been exposed to at least one device, with at least one endpoint recorded (data non-missing).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CLINY Reusable Catheter | Adverse Events | 11 Adverse events |