Sample Collection and Instruction Optimization (SCIO)

June 3, 2026 updated by: Pierre Van Damme, Universiteit Antwerpen

SCIO: Sample Collection and Instruction Optimization

The aim of this study is to improve the instructions for use and to evaluate the usability of a novel first-void urine collection device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants are asked to try a novel first-void urine collection device and give feedback on the instructions and usability of the device through a questionnaire. Further, only the volume of the collected sample is measured. A first group of 30 participants (15 men and 15 women) will be asked for a one-time visit. If any substantial changes need to be made based on the results of the questionnaire, a second group of 30 participants will be asked to evaluate the adapted version.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • University of Antwerp - Centre for the Evaluation of Vaccination
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Naïve to first-void urine collection (standard urine cup is allowed)
  • Able to understand the information brochure and what the study is about

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First-void urine collection
Use of first-void urine device and filling out questionnaire on the instructions for use and the usability after collection.
Device: First-void urine collection device
Use of a first-void urine collection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback usability
Time Frame: Immediately after use of the first-void urine collection device by participants
Collected data on the usability through questionnaire
Immediately after use of the first-void urine collection device by participants
Feedback instructions for use
Time Frame: Immediately after use of the first-void urine collection device by participants
Data collected on the instructions for use through questionnaire
Immediately after use of the first-void urine collection device by participants

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume first-void urine collected
Time Frame: Baseline (single visit)
Volume (in mL) of first-void urine sample collected by using the device
Baseline (single visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B3002026000061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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