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Trial Outcomes & Findings for Safety and Performance of a New Coating for Urinary Intermittent Catheters (NCT NCT01800903)

NCT ID: NCT01800903

Last Updated: 2020-09-10

Results Overview

Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

1 day

Results posted on

2020-09-10

Participant Flow

40 subjects were included in the safety population. 4 subjects discontinued because they were unable to catheterize with given catheter. these drop-outs were distributed evenly among the catheter types: 1. subject: ZN-C 2. subjects: ZN-D 1 subjects: SC These subjects were excluded from the ITT population as no endpoints were registered for them

Participant milestones

Participant milestones
Measure
SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter
First SpeediCath catheter then ZN-D catheter then ZN-C catheter
SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter
First SpeediCath catheter then ZN-C catheter then ZN-D catheter
ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter
First ZN-D catheter then SpeediCath catheter then ZN-C catheter
ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter
First ZN-D catheter then ZN-C catheter then SpeediCath catheter
ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter
First ZN-C catheter then SpeediCath catheter then ZN-D catheter
ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter
First ZN-C catheter then ZN-D catheter then SpeediCath catheter
First Test Period
STARTED
7
6
4
7
6
6
First Test Period
COMPLETED
7
6
4
7
6
6
First Test Period
NOT COMPLETED
0
0
0
0
0
0
Second Test Period
STARTED
7
6
4
7
6
6
Second Test Period
COMPLETED
6
6
4
7
6
6
Second Test Period
NOT COMPLETED
1
0
0
0
0
0
Third Test Period
STARTED
6
6
4
7
6
6
Third Test Period
COMPLETED
6
6
4
7
6
6
Third Test Period
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter
First SpeediCath catheter then ZN-D catheter then ZN-C catheter
SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter
First SpeediCath catheter then ZN-C catheter then ZN-D catheter
ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter
First ZN-D catheter then SpeediCath catheter then ZN-C catheter
ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter
First ZN-D catheter then ZN-C catheter then SpeediCath catheter
ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter
First ZN-C catheter then SpeediCath catheter then ZN-D catheter
ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter
First ZN-C catheter then ZN-D catheter then SpeediCath catheter
Second Test Period
unable to catheterise
1
0
0
0
0
0

Baseline Characteristics

Safety and Performance of a New Coating for Urinary Intermittent Catheters

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=36 Participants
The intention to treat population consists of 36 healthy male subjects
Age, Continuous
26.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.

Outcome measures

Outcome measures
Measure
ZN-D Catheter
n=35 Participants
Subjects who tested the ZN-D catheter
ZN-C Catheter
n=35 Participants
Subjects who tested the ZN-C catheter
SpeediCath
n=36 Participants
Subjects who tested the Speedicath catheter
Overall Discomfort During Catheterization
2.6 cm
Standard Deviation 2.2
2.4 cm
Standard Deviation 1.7
1.8 cm
Standard Deviation 1.5

Adverse Events

All Participants

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

Trine Møller Senior Clinical Manager

Coloplast A/S

Phone: +45 4911 2174

Results disclosure agreements

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