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

NCT ID: NCT03257306

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2022-12-31

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.

Conditions

Urinary Tract Stone; Kidney Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magnetic double-J ureteric stent

Double-J ureteric stent removed using magnet

Group Type: ACTIVE_COMPARATOR

ureteral double-J stent removal using magnet

Intervention Type: PROCEDURE

Double-J ureteric stent removed using magnet

ureteral double-J stent removal using cystoscopy

Intervention Type: PROCEDURE

Double-J ureteric stent removed using cystoscopy

Standard double-J ureteric stent

Double-J stent removed using cystoscopy

Group Type: ACTIVE_COMPARATOR

ureteral double-J stent removal using magnet

Intervention Type: PROCEDURE

Double-J ureteric stent removed using magnet

ureteral double-J stent removal using cystoscopy

Intervention Type: PROCEDURE

Double-J ureteric stent removed using cystoscopy

Interventions

ureteral double-J stent removal using magnet

Double-J ureteric stent removed using magnet

Intervention Type: PROCEDURE

ureteral double-J stent removal using cystoscopy

Double-J ureteric stent removed using cystoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Satakunta Central Hospital

OTHER

Sponsor Role: collaborator

Jyväskylä Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kari Syvanen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kari T Syvänen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Keski-Suomi Central Hospital

Jyväskylä, , Finland

Site Status: RECRUITING

Satakunta Central Hospital

Pori, , Finland

Site Status: RECRUITING

Turku University Hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Kari T Syvänen, MD, PhD

Role: CONTACT

kari.syvanen@tyks.fi

+3582313000

Otto Ettala, MD, PhD

Role: CONTACT

otto.ettala@tyks.fi

+3582313000

Facility Contacts

Heikki Seikkula, MD, PhD

Role: primary

heikki.seikkula@ksshp.fi

Teemu Joutsi, MD

Role: primary

teemu.joutsi@satshp.fi

Kari T Syvänen, MD, PhD

Role: primary

kari.syvanen@tyks.fi

+3582313000

Otto Ettala, MD, PhD

Role: backup

otto.ettala@tyks.fi

+3582313000

Other Identifiers

EMTK 66/1801/2017

Identifier Type: -

Identifier Source: org_study_id