Trial Outcomes & Findings for Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter (NCT NCT04250987)

NCT ID: NCT04250987

Last Updated: 2020-09-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2020-09-21

Participant Flow

Participant milestones

Measure	Participants Undergoing Catheterization With SpeediCath ® One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Participants Undergoing Catheterization With SpeediCath ® n=12 Participants One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Denmark	12 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Participants Undergoing Catheterization With SpeediCath ® n=12 Participants One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
Number of Participants With Readability of Pressure Sensor Measurements	11 Participants

Adverse Events

Participants Undergoing Catheterization With SpeediCath ®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President, Medical Affairs

Coloplast

Phone: +45 4911 1111

Email: clinical-studies@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place