Compliance, Patient
Conditions
Brief summary
The purpose of the investigational device in the proposed clinical investigation is to capture pressure data prior to and during voiding using a CE-marked commercially available catheter.
Detailed description
This clinical investigation is based on an open explorative design evaluating the sensor ability to record readable data in healthy volunteers and the extent of artifacts influencing data quality and readability in healthy volunteers. Overall: * Single arm. Open-labelled, not randomized * Healthy volunteers Duration: Information visit: Oral and written information about the evaluation is given by the PI or his/her representative. Subjects can continue to visit 0, inclusion visit, the same day - if the subject has decided on participation and if practically possible. Visit 0 - Inclusion visit: Informed consent signed. Subjects can continue to visit 1 - test visit the same day - if practically possible. Visit 1 - test visit: 1h test visit at Rigshospitalet. Fertile females will be asked to perform a pregnancy test. Subject is asked about symptoms for urinary tract infections (frequent urination, stinging or pain at urination). If negative for these symptoms, the subject will be catheterised with (SpeediCath® Standard, male/female, Nelaton tip depending of the gender) with fitted pressure sensor. The urine is led into a standard urine flowmeter.
Interventions
DEVICESpeediCath(R)
IC SpeediCath ® connected to pressure sensor
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Single arm - open-label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity
Exclusion criteria
1. Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract 2. Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion) 3. Participation in any other clinical investiga-tions during this investigation (Inclusion → termination) 4. Known hypersensitivity toward any of the test products 5. Positive pregnancy tes for women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Readability of Pressure Sensor Measurements | 1 hour | Determination of whether the sensor could detect changes in pressure in kilopascal (kPa) and provide a readable graph depicting changes in kPa over time of use of IC. Each pressure sensor graph is assessed visually to determine whether the instrument can be used in future studies on a Yes/No basis. The total number of participants with readable pressure sensor measurements were counted. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Undergoing Catheterization With SpeediCath ® One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Participants Undergoing Catheterization With SpeediCath ® |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment Denmark | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Number of Participants With Readability of Pressure Sensor Measurements
Determination of whether the sensor could detect changes in pressure in kilopascal (kPa) and provide a readable graph depicting changes in kPa over time of use of IC. Each pressure sensor graph is assessed visually to determine whether the instrument can be used in future studies on a Yes/No basis. The total number of participants with readable pressure sensor measurements were counted.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Undergoing Catheterization With SpeediCath ® | Number of Participants With Readability of Pressure Sensor Measurements | 11 Participants |