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

Coloplast

Status: Completed

Conditions: Compliance, Patient

Treatments: Device: SpeediCath(R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04250987

CP304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

IC connected to a sensor

Experimental group

Description:

Single use of a IC connected to a sensor

Treatment:

Device: SpeediCath(R)