Kidney Stone, Urinary Tract Stone
Conditions
Keywords
Urinary tract stone, ureter double-J stent
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.
Interventions
PROCEDUREureteral double-J stent removal using magnet
Double-J ureteric stent removed using magnet
PROCEDUREureteral double-J stent removal using cystoscopy
Double-J ureteric stent removed using cystoscopy
Sponsors
Kuopio University Hospital
Satakunta Central Hospital
Jyväskylä Central Hospital
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized, single-blinded, multi-institutional, non-inferiority study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The discomfort experienced by the patients during stent removal determined in 100mm Visual Analogue Scale (VAS). | 4 weeks after stent placement | More than 10mm difference between the two groups is considered as clinically significant. |
| The number of unsuccessful removals of the magnetic stent. | 4 weeks after stent placement | Unsuccessful removal using magnet |
Countries
Finland
Contacts
Primary ContactKari T Syvänen, MD, PhD
Backup ContactOtto Ettala, MD, PhD
Outcome results
None listed