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

NCT03257306 | Unknown

• 1 other identifier: EMTK 66/1801/2017
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

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.

Conditions

Urinary Tract Stone; Kidney Stone

Keywords

Urinary tract stone; ureter double-J stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• General health score in Ureteral Stent Symptom Questionnaire (USSQ)

  4 weeks after stent placement and 4 weeks after stent removal

• Sexual score in Ureteral Stent Symptom Questionnaire (USSQ)

  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 and 4 weeks after stent removal

• Urinary symptom score in Ureteral Stent Symptom Questionnaire (USSQ)

  4 weeks after stent placement and 4 weeks after stent removal

Other Outcomes (2)

• The discomfort experienced by the patients during stent removal determined in 100mm Visual Analogue Scale (VAS).

  4 weeks after stent placement

• The number of unsuccessful removals of the magnetic stent.

  4 weeks after stent placement

Study Arms (2)

Magnetic double-J ureteric stent

ACTIVE COMPARATOR

Double-J ureteric stent removed using magnet

Procedure: ureteral double-J stent removal using magnet; Procedure: ureteral double-J stent removal using cystoscopy

Standard double-J ureteric stent

ACTIVE COMPARATOR

Double-J stent removed using cystoscopy

Procedure: ureteral double-J stent removal using magnet; Procedure: ureteral double-J stent removal using cystoscopy

Interventions

ureteral double-J stent removal using magnet PROCEDURE

Double-J ureteric stent removed using magnet

Magnetic double-J ureteric stent; Standard double-J ureteric stent

ureteral double-J stent removal using cystoscopy PROCEDURE

Double-J ureteric stent removed using cystoscopy

Magnetic double-J ureteric stent; Standard double-J ureteric stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• Kuopio University Hospital: collaborator
• Satakunta Central Hospital: collaborator
• Jyväskylä Central Hospital: collaborator

Study Sites (3)

Keski-Suomi Central Hospital

Jyväskylä, Finland

RECRUITING

Satakunta Central Hospital

Pori, Finland

RECRUITING

Turku University Hospital

Turku, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Urinary Calculi; Kidney Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases

Study Officials

• Kari T Syvänen, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kari T Syvänen, MD, PhD

CONTACT

+3582313000; kari.syvanen@tyks.fi

Otto Ettala, MD, PhD

CONTACT

+3582313000; otto.ettala@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized, single-blinded, multi-institutional, non-inferiority study

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 22, 2017
• Study Start: November 9, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

FI (3)