Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)

Study Overview
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Brief Summary
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The specific aim of this study is to validate our hypothesis that the magnetic ureteral stents have the same amount of adverse effects as the more commonly used non-magnetic ureteral stents. If this hypothesis would be confirmed then the usage of magnetic ureteral stents would be justified for both reducing patient discomfort by way of fewer cystoscopies and possibly also decreasing the overall expenditures of treatment.

Detailed Description
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Many urological procedures involving the kidney and the ureters require a stent replacement to avoid un-wanted adverse invents caused by the procedure itself. The stenting, however, predisposes the patient to adverse effects of its own and the application and removal of the stent is a notable monetary expense. The use of magnetic ureteral stents that can be removed via catheter instead of requiring an additional cystoscopy for removal would reduce the discomfort to patients and also possibly decrease the expenditures of the overall treatment. However, the comparability of standard ureteral stents and the magnetic ureteral stents is largely unknown due to there being no published research on the subject as of this time. The specific aim of this study is to validate our hypothesis that the magnetic ureteral stents have the same amount of adverse effects as the more commonly used non-magnetic ureteral stents. The design is as prospective randomized, single-blinded, multi-institutional, non-inferiority study conducted in Hospital Districts of Southwest Finland, Päijät-Häme, Pohjois-Savo, Satakunta and Keski-Suomi. Using age and gender stratification, patients are randomised 1:1 fashion into having a magnetic (n=85) or standard ureter stent (n=85). The primary objectives are the mean differences between the two groups in pain and urinary symptoms scores determined by the Ureteral Stent Symptom Questionnaire (USSQ) 4 weeks after stent placement. The patients will be recruited starting from the 4rd quarter of 2018 and ending during the 3rd quarter of 2020. Preliminary analysis of all results will be available in September 2020 and reports are expected to be written during December 2020.

Official Title
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Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)

Conditions
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Urinary Tract Stone, Kidney Stone

Intervention / Treatment
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* Procedure: ureteral double-J stent removal using magnet
* Procedure: ureteral double-J stent removal using cystoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Language spoken: Finnish Clinically evaluated need for short term ureter stenting in course of extracorporeal shockwave lithotripsy-treatment or after pyeloscopy Mental status: Patients must be able to understand the meaning of the study Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: Current use of alpha blockers Patients undergoing emergency ureteroscopy and stenting Patients with a long term ureter stents Any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized, single-blinded, multi-institutional, non-inferiority study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnetic double-J ureteric stent<br>Double-J ureteric stent removed using magnet | Procedure: ureteral double-J stent removal using magnet<br>* Double-J ureteric stent removed using magnet<br>Procedure: ureteral double-J stent removal using cystoscopy<br>* Double-J ureteric stent removed using cystoscopy<br>|
| Active Comparator: Standard double-J ureteric stent<br>Double-J stent removed using cystoscopy | Procedure: ureteral double-J stent removal using magnet<br>* Double-J ureteric stent removed using magnet<br>Procedure: ureteral double-J stent removal using cystoscopy<br>* Double-J ureteric stent removed using cystoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ) | 4 weeks after stent placement. [5] Less than 5 points of difference between the two study groups is considered as clinically insignificant. | 4 weeks after stent placement and 4 weeks after stent removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health score in Ureteral Stent Symptom Questionnaire (USSQ) | 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant. | 4 weeks after stent placement and 4 weeks after stent removal | 
| Sexual score in Ureteral Stent Symptom Questionnaire (USSQ) | 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant. | 4 weeks after stent placement and 4 weeks after stent removal | 
| Working performance score in Ureteral Stent Symptom Questionnaire (USSQ) | 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant. | 4 weeks after stent placement and 4 weeks after stent removal | 
| Urinary symptom score in Ureteral Stent Symptom Questionnaire (USSQ) | 4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant. | 4 weeks after stent placement and 4 weeks after stent removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary tract stone, ureter double-J stent