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Intermittent Catheterization in Spinal Cord Injured Men

Primary Purpose

Spinal Cord Injuries

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
SelfCath (comparator)
Product A SelfCath and urine bag, Conveen Security+
Product B SelfCath and urine bag, Conveen Contour
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Per Bagi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence A

Sequence B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2014
Last Updated
February 17, 2016
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02230540
Brief Title
Intermittent Catheterization in Spinal Cord Injured Men
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SelfCath (comparator)
Intervention Description
Commercially available CE-marked catheter for urinary drainage.
Intervention Type
Device
Intervention Name(s)
Product A SelfCath and urine bag, Conveen Security+
Intervention Description
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
Intervention Type
Device
Intervention Name(s)
Product B SelfCath and urine bag, Conveen Contour
Intervention Description
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
Primary Outcome Measure Information:
Title
Residual Volume Less Than 100ml
Description
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.
Time Frame
2-4 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Bagi, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Per Bagi
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Intermittent Catheterization in Spinal Cord Injured Men

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