Patient-driven Compression in Urography

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient-driven Compression in Urography

Conditions
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Urologic Diseases

Intervention / Treatment
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* Device: Patient-regulated compression device
* Device: Standard compression device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-regulated compression<br>Patient-regulated compression device | Device: Patient-regulated compression device<br>* Compression of the abdomen with a patient-regulated compression device<br>|
| Active Comparator: Standard compression<br>Standard compression device | Device: Standard compression device<br>* Compression of the abdomen with the standard compression device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose measured as Dose-area product | Radiation dose for the investigated exposures, measured as Dose-area product | Immediately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality measured with Visual Grading | Image quality for the investigated images, measured with Visual Grading | Immediately | 
| Patient experience (questionnaire) | A questionnaire will be analysed with qualitative content analysis | Immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urography, Radiation dosage, image enhancement