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

Kidney Stone Clinical Trial

— MAGUSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03257306
• Other study ID #: EMTK 66/1801/2017
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Turku University Hospital
• Contact: Kari T Syvänen, MD, PhD
• Phone: +3582313000
• Email: kari.syvanen[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Urinary Calculi
• Urinary Tract Stone

Intervention

Procedure:
• ureteral double-J stent removal using magnet
Double-J ureteric stent removed using magnet
• ureteral double-J stent removal using cystoscopy
Double-J ureteric stent removed using cystoscopy

Locations

Country	Name	City	State
Finland	Keski-Suomi Central Hospital	Jyväskylä
Finland	Satakunta Central Hospital	Pori
Finland	Turku University Hospital	Turku

Sponsors (4)

Lead Sponsor	Collaborator
Turku University Hospital	Jyväskylä Central Hospital, Kuopio University Hospital, Satakunta Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The discomfort experienced by the patients during stent removal determined in 100mm Visual Analogue Scale (VAS).	More than 10mm difference between the two groups is considered as clinically significant.	4 weeks after stent placement
Other	The number of unsuccessful removals of the magnetic stent.	Unsuccessful removal using magnet	4 weeks after stent placement
Primary	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	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
Secondary	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
Secondary	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
Secondary	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