NCT04231149

Brief Summary

Performance and acceptance of new intermittent catheters tested in healthy volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

March 24, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

May 28, 2019

Results QC Date

January 29, 2020

Last Update Submit

March 5, 2025

Conditions

Compliance, Patient

Outcome Measures

Primary Outcomes (1)

  • Urine Flow Rate

    On day of study visits 1-5 rate of urine flow through catheter measured in mL/s

    2 hour

Secondary Outcomes (2)

  • Post-void Residual Urine

    2 hour

  • Number of Participants With Hematuria

    2 hour

Study Arms (3)

Test product 2

EXPERIMENTAL

Test catheter 2

Device: Test product 3Device: Comparator

Test product 3

EXPERIMENTAL

Test catheter 3

Device: Test product 2Device: Comparator

Comparator

ACTIVE COMPARATOR

SpeediCath Flex

Device: Test product 2Device: Test product 3

Interventions

Test product 2DEVICE

Test catheter 2

ComparatorTest product 3
Test product 3DEVICE

Test catheter 3

ComparatorTest product 2
ComparatorDEVICE

SpeediCath Flex

Test product 2Test product 3

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSubjects need a penis for male urinary catheter use
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Medical Affairs Vice President
Organization
Coloplast A/S
clinical-studies@coloplast.com
+45 4911 1111

Study Officials

  • Birte Jakobsen, MD

    Coloplast A/S

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

January 18, 2020

Study Start

November 5, 2018

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

March 24, 2025

Results First Posted

March 24, 2025

Record last verified: 2025-03

Locations

DK(1)