Intermittent Catheterization in Spinal Cord Injured Men

Study Overview
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Brief Summary
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The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: SelfCath (comparator)
* Device: Product A SelfCath and urine bag, Conveen Security+
* Device: Product B SelfCath and urine bag, Conveen Contour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has given written informed consent Is at least 18 years of age and has full legal capacity Is a male Has an Spinal Cord Injury diagnosis Exclusion Criteria: Participating in other interventional clinical investigations or have previously participated in this investigation Known hypersensitivity toward any of the test products Serious abdominal scars Symptoms of urinary tract infections

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions. Measurement of residual urine at different positions. | Device: SelfCath (comparator)<br>* Commercially available CE-marked catheter for urinary drainage.<br>Device: Product A SelfCath and urine bag, Conveen Security+<br>* SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).<br>|
| Experimental: Sequence B<br>Based on results from sequence A, sequence B may or may not be initiated. Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product B in different positions. Measurement of residual urine at different positions. | Device: SelfCath (comparator)<br>* Commercially available CE-marked catheter for urinary drainage.<br>Device: Product B SelfCath and urine bag, Conveen Contour<br>* SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Volume Less Than 100ml | The primary endpoint was Residual volume less than 100 ml (Yes/No) assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from 300ml - collected volume <100ml to collected volume > 200ml, were used to interpret the primary endpoint. | 2-4 hours |