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

Not Applicable

• Conditions: Kidney Stone; Urinary Tract Stone
• Interventions: Procedure: ureteral double-J stent removal using magnet; Procedure: ureteral double-J stent removal using cystoscopy

• Registration Number: NCT03257306
• Lead Sponsor: Turku University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-22
• Study Start: 2018-11-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-08
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic double-J ureteric stent	ureteral double-J stent removal using cystoscopy	Double-J ureteric stent removed using magnet
Magnetic double-J ureteric stent	ureteral double-J stent removal using magnet	Double-J ureteric stent removed using magnet
Standard double-J ureteric stent	ureteral double-J stent removal using magnet	Double-J stent removed using cystoscopy
Standard double-J ureteric stent	ureteral double-J stent removal using cystoscopy	Double-J stent removed using cystoscopy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Keski-Suomi Central Hospital; 🇫🇮 Jyväskylä, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Satakunta Central Hospital; 🇫🇮 Pori, Finland