Urinary Tract StoneMAGUSSNCT03257306
Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)
A study testing ureteral double-J stent removal using magnet and ureteral double-J stent removal using cystoscopy in people with Urinary Tract Stone and Kidney Stone, run by Turku University Hospital at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Urinary Tract Stone, Kidney Stone
- What is being tested?
- ureteral double-J stent removal using magnet and ureteral double-J stent removal using cystoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesFinland
- Study dates
- 9 Nov 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites, 3 recruiting
- Recruiting
Keski-Suomi Central Hospital
Jyväskylä
Heikki Seikkula, MD, PhD, heikki.seikkula@ksshp.fi
- Recruiting
Satakunta Central Hospital
Pori
Teemu Joutsi, MD, teemu.joutsi@satshp.fi
Lauri Reunanen, MD
- Recruiting
Turku University Hospital
Turku, 20521
Kari T Syvänen, MD, PhD, +3582313000, kari.syvanen@tyks.fi
Otto Ettala, MD, PhD, +3582313000, otto.ettala@tyks.fi
About this study
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.
Read the 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
- Being tested
- ureteral double-J stent removal using magnet, ureteral double-J stent removal using cystoscopy
- Keywords
- Urinary tract stone, ureter double-J stent
- Medical subject headings
- Urinary Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ureteral double-J stent removal using magnetProcedure or surgery
Double-J ureteric stent removed using magnet
ureteral double-J stent removal using cystoscopyProcedure or surgery
Double-J ureteric stent removed using cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| Magnetic double-J ureteric stent | Active comparator | Double-J ureteric stent removed using magnet Receives: 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 Receives: Procedure: ureteral double-J stent removal using magnet; Procedure: ureteral double-J stent removal using cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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. Scores less than 4 points of difference between the two study groups is considered as clinically insignificant.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks after stent placement and 4 weeks after stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start9 Nov 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract StoneStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized, single-blinded, multi-institutional, non-inferiority study
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Kuopio University Hospital, Satakunta Central Hospital, Jyväskylä Central Hospital
- Responsible party
- Principal investigator, Kari Syvanen, Turku University Hospital
- Investigators
- Kari T Syvänen, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257306
- Sponsor's protocol ID
- EMTK 66/1801/2017
- Acronym
- MAGUSS
- Status last verified
- Oct 2021
- First submitted
- 2 Aug 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)
- ClinicalTrials.gov ID
- NCT03257306
- Acronym / sponsor ID
- MAGUSS / EMTK 66/1801/2017
- Conditions
- Urinary Tract Stone, Kidney Stone
- Keywords
- Urinary tract stone, ureter double-J stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Kuopio University Hospital, Satakunta Central Hospital, Jyväskylä Central Hospital
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized, single-blinded, multi-institutional, non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Magnetic double-J ureteric stent | Active comparator | Procedure: ureteral double-J stent removal using magnet, Procedure: ureteral double-J stent removal using cystoscopyDouble-J ureteric stent removed using magnet |
| Standard double-J ureteric stent | Active comparator | Procedure: ureteral double-J stent removal using magnet, Procedure: ureteral double-J stent removal using cystoscopyDouble-J stent removed using cystoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ureteral double-J stent removal using magnetDouble-J ureteric stent removed using magnet | Procedure or surgery | Magnetic double-J ureteric stent, Standard double-J ureteric stent |
| ureteral double-J stent removal using cystoscopyDouble-J ureteric stent removed using cystoscopy | Procedure or surgery | Magnetic double-J ureteric stent, Standard double-J ureteric stent |
Primary outcome
Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: 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.
4 secondary outcomes
General health score in Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: 4 weeks after stent placement and 4 weeks after stent removal
Sexual score in Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: 4 weeks after stent placement and 4 weeks after stent removal
Working performance score in Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: 4 weeks after stent placement and 4 weeks after stent removal
Urinary symptom score in Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: 4 weeks after stent placement and 4 weeks after stent removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari T Syvänen, MD, PhD principal investigator
Turku University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ureteral double-J stent removal using magnet and ureteral double-J stent removal using cystoscopy in people with Urinary Tract Stone and Kidney Stone, run by Turku University Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kari T Syvänen, MD, PhD (+3582313000, kari.syvanen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ) (time frame: 4 weeks after stent placement and 4 weeks after stent removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.