An interventional study of ureteral double-J stent removal using magnet and ureteral double-J stent removal using cystoscopy in Urinary Tract Stone and Kidney Stone, sponsored by Turku University Hospital. Status unknown at 3 sites in Finland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Treatment
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.
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 170 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Turku University Hospital is the lead sponsor of 287 studies on the registry; 67 are open to participants now.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Calculi. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Double-J ureteric stent removed using magnet
Procedure: ureteral double-J stent removal using magnet · Procedure: ureteral double-J stent removal using cystoscopy
Double-J stent removed using cystoscopy
Procedure: ureteral double-J stent removal using magnet · Procedure: ureteral double-J stent removal using cystoscopy
Double-J ureteric stent removed using magnet
Double-J ureteric stent removed using cystoscopy
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.
Time frame: 4 weeks after stent placement and 4 weeks after stent removal
General health score in Ureteral Stent Symptom Questionnaire (USSQ)
4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
Time frame: 4 weeks after stent placement and 4 weeks after stent removal
Sexual score in Ureteral Stent Symptom Questionnaire (USSQ)
4 weeks after stent placement. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
Time frame: 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. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
Time frame: 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. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
Time frame: 4 weeks after stent placement and 4 weeks after stent removal
The discomfort experienced by the patients during stent removal determined in 100mm Visual Analogue Scale (VAS).
More than 10mm difference between the two groups is considered as clinically significant.
Time frame: 4 weeks after stent placement
The number of unsuccessful removals of the magnetic stent.
Unsuccessful removal using magnet
Time frame: 4 weeks after stent placement
Started Nov 2018 (actual). Primary completion is estimated for Dec 2022, 49 months after the start.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 49 months is above that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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