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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Stone; Urinary Tract Stone
• Intervention / Treatment: Procedure: ureteral double-J stent removal using magnet; Procedure: ureteral double-J stent removal using cystoscopy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kari T Syvänen, MD, PhD; Phone Number: +3582313000; Email: kari.syvanen@tyks.fi
• Study Contact Backup: Name: Otto Ettala, MD, PhD; Phone Number: +3582313000; Email: otto.ettala@tyks.fi

Study Locations

• Finland
  • Jyväskylä, Finland
    • Recruiting
    • Keski-Suomi Central Hospital
    • Contact: Heikki Seikkula, MD, PhD; Email: heikki.seikkula@ksshp.fi
  • Pori, Finland
    • Recruiting
    • Satakunta Central Hospital
    • Contact: Teemu Joutsi, MD; Email: teemu.joutsi@satshp.fi
    • Sub-Investigator: Lauri Reunanen, MD
  • Turku, Finland, 20521
    • Recruiting
    • Turku University Hospital
    • Contact: Kari T Syvänen, MD, PhD; Phone Number: +3582313000; Email: kari.syvanen@tyks.fi
    • Contact: Otto Ettala, MD, PhD; Phone Number: +3582313000; Email: otto.ettala@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The number of unsuccessful removals of the magnetic stent.	Unsuccessful removal using magnet	4 weeks after stent placement

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Kuopio University Hospital; Satakunta Central Hospital; Jyväskylä Central Hospital
• Investigators: Principal Investigator: Kari T Syvänen, MD, PhD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Urinary tract stone; ureter double-J stent
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Calculi; Nephrolithiasis; Urinary Calculi; Kidney Calculi
• Other Study ID Numbers: EMTK 66/1801/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No