Comparison of Microtrauma in Urethra After Usage of Different Catheters
NCT ID: NCT01600443
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2012-04-30
2012-05-31
Brief Summary
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Each subject will be randomized to use three different catheter types. Three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. The washout period between catheter switch will be at least one week.
The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization.
The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization.
The safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality.
The hypothesis that level of hematuria is equal after using different catheters will be tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is less than 5%.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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LoFric - SC - SCCM
Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
LoFric - SCCM - SC
Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
SC - SCCM - LoFric
Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
SC - LoFric - SCCM
Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
SCCM - LoFric - SC
Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
SCCM - SC - LoFric
Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
Interventions
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LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
Eligibility Criteria
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Inclusion Criteria
2. Healthy male volunteers aged 18 years and over (half of the included subjects shall be 18-50 years and the other half \>50 years old)
3. Negative urine dipstick test (no blood in the urine) before randomization
Exclusion Criteria
2. Intake of antibiotics at enrolment and during the study period
3. Urinary tract infection (UTI) at enrolment and during the study period
4. Known abnormalities or diseases of the lower urinary tract with the exception of BPH
5. Kidney stones
6. Tumour in the urinary tract
7. Known Sexually transferable diseases in the urinary tract during the study period
8. Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
9. Previous enrolment or randomisation of treatment in the present study
10. Simultaneous participation in another clinical study that might interfere with the endpoints of the study, as deemed by the investigator
11. Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
18 Years
MALE
Yes
Sponsors
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Wellspect HealthCare
INDUSTRY
Responsible Party
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Principal Investigators
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Ulf Malmkvist, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital
Locations
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Clinical Trial Unit, R&D Centre Skåne, Skåne University Hospital
Lund, , Sweden
Countries
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Other Identifiers
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LOF-0022
Identifier Type: -
Identifier Source: org_study_id
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