Trial Outcomes & Findings for Product Evaluation of a Newly Developed Intermittent Catheter. (NCT NCT02966015)

Results Overview

The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

1 week

Results posted on

2018-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Tiemann/Coudé Users The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter	Traditional Sleeve Catheter Users The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
Inclusion Visit STARTED	95	58
Inclusion Visit COMPLETED	87	55
Inclusion Visit NOT COMPLETED	8	3
Test Period STARTED	87	55
Test Period COMPLETED	87	55
Test Period NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tiemann/Coudé Users The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter	Traditional Sleeve Catheter Users The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
Inclusion Visit did not answer questionnaire	8	3

Baseline Characteristics

Product Evaluation of a Newly Developed Intermittent Catheter.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tiemann/Coudé Users n=95 Participants The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter	Traditional Sleeve Catheter Users n=58 Participants The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.	Total n=153 Participants Total of all reporting groups
Age, Customized Participants older than 18 years	95 participants n=99 Participants	58 participants n=107 Participants	153 participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	95 Participants n=99 Participants	58 Participants n=107 Participants	153 Participants n=206 Participants

PRIMARY outcome

Timeframe: 1 week

The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.

Outcome measures

Outcome measures
Measure	Tiemann/Coudé Users n=95 Participants The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter	Traditional Sleeve Catheter Users n=58 Participants The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
Number of Participants Successfully Able to Insert Catheter	82 Participants	58 Participants

Adverse Events

Tiemann/Coudé Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Sleeve Catheter Users

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

Head of clinical operations

Clinical operations,Medical Affairs

Phone: +45 49113267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60