Clinical trial NCT03257306: Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)
Official title: Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Stone
Kidney Stone
Keywords: Urinary tract stone
ureter double-J stent
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Kuopio University Hospital
name: Satakunta Central Hospital
name: Jyväskylä Central Hospital
First posted: 2017-08-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized, single-blinded, multi-institutional, non-inferiority study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: 4 weeks after stent placement and 4 weeks after stent removal
Secondary outcomes:
measure: General health score in Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: 4 weeks after stent placement and 4 weeks after stent removal
measure: Sexual score in Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: 4 weeks after stent placement and 4 weeks after stent removal
measure: Working performance score in Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: 4 weeks after stent placement and 4 weeks after stent removal
measure: Urinary symptom score in Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: 4 weeks after stent placement and 4 weeks after stent removal
Other outcomes:
measure: The discomfort experienced by the patients during stent removal determined in 100mm Visual Analogue Scale (VAS).
timeFrame: 4 weeks after stent placement
measure: The number of unsuccessful removals of the magnetic stent.
timeFrame: 4 weeks after stent placement
Locations:
city: Jyväskylä
country: Finland
facility: Keski-Suomi Central Hospital
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Kari T Syvänen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: