Intermittent Catheterization in Spinal Cord Injured Men

Spinal Cord Injuries Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02230540
• Other study ID #: CP250
• Status: Terminated
• Phase: N/A
• First received: August 28, 2014
• Last updated: February 17, 2016
• Start date: September 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2016
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• SelfCath (comparator)
Commercially available CE-marked catheter for urinary drainage.
• Product A SelfCath and urine bag, Conveen Security+
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
• Product B SelfCath and urine bag, Conveen Contour
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).

Locations

Country	Name	City	State
Denmark	Per Bagi	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No