Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter

Conditions
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Compliance, Patient

Intervention / Treatment
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* Device: SpeediCath(R)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Exclusion Criteria: Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion) Participation in any other clinical investiga-tions during this investigation (Inclusion → termination) Known hypersensitivity toward any of the test products Positive pregnancy tes for women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm - open-label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC connected to a sensor<br>Single use of a IC connected to a sensor | Device: SpeediCath(R)<br>* IC SpeediCath ® connected to pressure sensor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour |