Intermittent Catheterization in Spinal Cord Injured Men

Not Applicable

Terminated

• Conditions: Spinal Cord Injuries
• Interventions: Device: SelfCath (comparator); Device: Product B SelfCath and urine bag, Conveen Contour; Device: Product A SelfCath and urine bag, Conveen Security+

• Registration Number: NCT02230540
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study Start: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Results First Submitted: 2016-01-18
• Results First Submitted QC: 2016-01-18
• Status Verified: 2016-02
• Results First Posted: 2016-02-15
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequence B	Product B SelfCath and urine bag, Conveen Contour	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.
Sequence A	Product A SelfCath and urine bag, Conveen Security+	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.
Sequence A	SelfCath (comparator)	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.
Sequence B	SelfCath (comparator)	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.

Primary Outcome Measures

Name	Time	Method
Residual Volume Less Than 100ml	2-4 hours	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.

Trial Locations

Locations (1)

Per Bagi; 🇩🇰 Copenhagen, Denmark