Intermittent Catheterization in Spinal Cord Injured Men

February 17, 2016 updated by: Coloplast A/S
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Per Bagi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Volume Less Than 100ml
Time Frame: 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.
2-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Per Bagi, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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