Comparison of Microtrauma in Urethra After Usage of Different Catheters

Study Overview
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Brief Summary
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The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a prospective, randomised, cross-over, single-centre study. 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%.

Official Title
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A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.

Conditions
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Hematuria

Intervention / Treatment
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* Device: LoFric
* Device: SpeediCath
* Device: SpeediCath Compact Male


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Provision of informed consent 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) Negative urine dipstick test (no blood in the urine) before randomization Exclusion Criteria: Intake of anticoagulants at enrolment and during the study period Intake of antibiotics at enrolment and during the study period Urinary tract infection (UTI) at enrolment and during the study period Known abnormalities or diseases of the lower urinary tract with the exception of BPH Kidney stones Tumour in the urinary tract Known Sexually transferable diseases in the urinary tract during the study period Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site) Previous enrolment or randomisation of treatment in the present study Simultaneous participation in another clinical study that might interfere with the endpoints of the study, as deemed by the investigator Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoFric - SC - SCCM<br>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. | Device: LoFric<br>* Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.<br>Device: SpeediCath<br>* Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.<br>Device: SpeediCath Compact Male<br>* Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.<br>|
| Experimental: LoFric - SCCM - SC<br>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. | Device: LoFric<br>* Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.<br>Device: SpeediCath<br>* Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.<br>Device: SpeediCath Compact Male<br>* Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.<br>|
| Experimental: SC - SCCM - LoFric<br>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. | Device: LoFric<br>* Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.<br>Device: SpeediCath<br>* Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.<br>Device: SpeediCath Compact Male<br>* Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.<br>|
| Experimental: SC - LoFric - SCCM<br>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. | Device: LoFric<br>* Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.<br>Device: SpeediCath<br>* Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.<br>Device: SpeediCath Compact Male<br>* Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.<br>|
| Experimental: SCCM - LoFric - SC<br>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. | Device: LoFric<br>* Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.<br>Device: SpeediCath<br>* Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.<br>Device: SpeediCath Compact Male<br>* Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.<br>|
| Experimental: SCCM - SC - LoFric<br>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. | Device: LoFric<br>* Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.<br>Device: SpeediCath<br>* Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.<br>Device: SpeediCath Compact Male<br>* Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematuria | Blood in urine (measured by microscopic urine sediment evaluation) will be assessed at the first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days. | Approximately 2 hours after last catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematuria | Blood in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days. | At first, second and third catheterization, approximately 2 hours apart | 
| Pyuria | White blood cells in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days. | At first, second and third catheterization, approximately 2 hours apart | 
| Pyuria | White blood cells in urine (measured by microscopic urine sediment evaluation) will be assessed at first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days. | Approximately 2 hours after last catheterization |