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Patient-driven Compression in Urography

Primary Purpose

Urologic Diseases

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Patient-regulated compression device
Standard compression device
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urologic Diseases focused on measuring Urography, Radiation dosage, image enhancement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatients with a request for a urographic study

Exclusion Criteria:

  • Emergency studies,
  • cannot participate actively with compression,
  • contraindications to compression of the abdomen,
  • pregnancy,
  • inability to understand the language of the questionnaire

Sites / Locations

  • Department of Radiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient-regulated compression

Standard compression

Arm Description

Patient-regulated compression device

Standard compression device

Outcomes

Primary Outcome Measures

Radiation dose measured as Dose-area product
Radiation dose for the investigated exposures, measured as Dose-area product

Secondary Outcome Measures

Image quality measured with Visual Grading
Image quality for the investigated images, measured with Visual Grading
Patient experience (questionnaire)
A questionnaire will be analysed with qualitative content analysis

Full Information

First Posted
December 2, 2015
Last Updated
February 24, 2016
Sponsor
Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02622269
Brief Title
Patient-driven Compression in Urography
Official Title
Patient-driven Compression in Urography
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression. Evaluation of radiation dose, image quality and patients' experiences
Detailed Description
Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse. Two compression devices are investigated in each patient, in randomized order. Aims of the study: Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression. Evaluate image quality with the two devices. Describe patients' experiences from using the two devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases
Keywords
Urography, Radiation dosage, image enhancement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-regulated compression
Arm Type
Experimental
Arm Description
Patient-regulated compression device
Arm Title
Standard compression
Arm Type
Active Comparator
Arm Description
Standard compression device
Intervention Type
Device
Intervention Name(s)
Patient-regulated compression device
Intervention Description
Compression of the abdomen with a patient-regulated compression device
Intervention Type
Device
Intervention Name(s)
Standard compression device
Intervention Description
Compression of the abdomen with the standard compression device
Primary Outcome Measure Information:
Title
Radiation dose measured as Dose-area product
Description
Radiation dose for the investigated exposures, measured as Dose-area product
Time Frame
Immediately
Secondary Outcome Measure Information:
Title
Image quality measured with Visual Grading
Description
Image quality for the investigated images, measured with Visual Grading
Time Frame
Immediately
Title
Patient experience (questionnaire)
Description
A questionnaire will be analysed with qualitative content analysis
Time Frame
Immediately after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients with a request for a urographic study Exclusion Criteria: Emergency studies, cannot participate actively with compression, contraindications to compression of the abdomen, pregnancy, inability to understand the language of the questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håkan Geijer, MD, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Patient-driven Compression in Urography

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