Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Comparative Study of Two Different Urine Catheters.
1 other identifier
interventional
41
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Shorter than P25 for not_applicable
1 active site
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, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedResults Posted
Study results publicly available
August 9, 2011
CompletedOctober 7, 2011
October 1, 2011
4 months
May 4, 2010
March 22, 2011
October 4, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Discomfort Measured on the Visual Analog Scale (VAS)
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Secondary Outcomes (5)
Irritation During Voiding After Catheterization
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Insertion Effort
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Visible Blood
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Haematuria
2 hours after catheterisation at visits 1 and 2
Study Arms (2)
Monza
EXPERIMENTALnonCE marked intermittent catheter
control
ACTIVE COMPARATORSpeediCath coated catheter
Interventions
intermittent catheterisation
Eligibility Criteria
You may qualify if:
- years or older
- Male
- signed informed Consent,
- Neg. 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
- Coloplast A/Slead
Study Sites (1)
Rigshospitalet, dep. 2112
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trine Møller Kruse
- Organization
- Clinical Regulatory Development, Global R&D
Study Officials
- STUDY DIRECTOR
Rikke Otttesen, CTM
Coloplast A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
May 4, 2010
First Posted
June 11, 2010
Study Start
January 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
October 7, 2011
Results First Posted
August 9, 2011
Record last verified: 2011-10