NCT00832078

Brief Summary

The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable healthy

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

January 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 5, 2012

Completed
Last Updated

September 5, 2012

Status Verified

August 1, 2012

Enrollment Period

3 months

First QC Date

January 26, 2009

Results QC Date

January 9, 2012

Last Update Submit

August 2, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Discomfort

    Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)

    After each catheterisation

Secondary Outcomes (3)

  • Handling

    After each catheterisation

  • Preference

    At study termination

  • Haematuria

    After each catheterisation

Study Arms (2)

Group A

OTHER

SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2

Device: SpeediCath Compact MaleDevice: Speedicath

Group B

OTHER

SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2

Device: SpeediCath Compact MaleDevice: Speedicath

Interventions

SpeediCath Compact MaleDEVICE

CH 12 hydrophilic coated intermitten compact catheter

Group AGroup B
SpeedicathDEVICE

CH 12 hydrophilic coated intermittent coated catheter

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Male
  • Signed informed consent
  • Negative urine multistix

You may not qualify if:

  • Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshopsitalet

Copenhagen, København Ø, 2100, Denmark

Location

Results Point of Contact

Title
Scientific Manager
Organization
Coloplast
dkkg@coloplast.com
+4549113557

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 29, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

September 5, 2012

Results First Posted

September 5, 2012

Record last verified: 2012-08

Locations

DK(1)