Urinary Incontinence
Conditions
Brief summary
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.
Detailed description
This investigation was a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.
Interventions
DEVICEInvestigational prototype device
The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
DEVICEComparator device
The comparator is a urinary catheter for bladder drainage through the urethra.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
1. Has given written informed consent 2. Is at least 18 years and have full legal capacity 3. Is female 4. Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
Exclusion criteria
1. Has used an internal urinary catheter or cystoscopy within the past month 2. Has prior history of bladder surgery 3. Is symptomatic and/or on medication for overactive bladder 4. Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate) 5. Is pregnant and/or breast-feeding 6. Is participating in other clinical investigations during this investigation 7. Is menstruating during study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. | 2 days | Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions, |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prototype Catheter Healthy volunteers to test the prototype investigational intermittent catheter.
Test Catheter: The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use. | 21 |
| Comparator Catheter Healthy volunteers to test the comparator catheter.
Comparator catheter: The comparator is a urinary catheter for bladder drainage through the urethra, for intermittent use. | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| V2, Catheterization and Visualization | Adverse Event | 2 | 1 |
Baseline characteristics
| Characteristic | Prototype Catheter | Comparator Catheter | Total |
|---|---|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 14.7 | 38.4 years STANDARD_DEVIATION 16.7 | 39.7 years STANDARD_DEVIATION 15.6 |
| Prophylactic antibiotics | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 9 / 19 | 2 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.
Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions,
Time frame: 2 days
Population: Intention to treat (ITT)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Change in Bladder Mucosa Pre- and Post-catheterization for the Prototype Catheter | Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. | 0.84 score on a scale |
| Change in Bladder Mucosa Pre- and Post-catheterization for the Comparator Catheter | Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. | 0.76 score on a scale |