MAG-EX study protocol: magnetic stent versus stent on extraction string in patients after ureteroscopy-a multi-centre...

Area of Science:

• Urology
• Medical Devices
• Clinical Trials

Background:

• Post-operative ureteric stents are crucial after urolithiasis interventions to prevent obstruction.
• Premature stent dislodgement and cystoscopic removal incur significant clinical and economic burdens.
• Alternative stents like magnetic stents and SOES aim to simplify stent removal.

Purpose of the Study:

• To compare the reliability of magnetic stents versus SOES in preventing premature removal and the need for cystoscopic removal.
• To evaluate patient-reported outcomes, including symptom scores and satisfaction, between the two stent types.
• To analyze the cost-effectiveness of magnetic stents compared to SOES in post-ureteroscopy patients.

Main Methods:

• A prospective, multicentre, randomized clinical trial (MAG-EX) involving 276 adult patients undergoing ureteroscopy for unilateral stone disease.
• Participants were randomized to receive either SOES or magnetic stents.
• Primary outcome: rate of premature or cystoscopic removal within one week; Secondary outcomes: patient-reported measures (USSQ, VAS, PROMs), satisfaction, and cost analysis.

Main Results:

• The trial is designed to detect an 8% difference in complication rates with 80% power.
• Data collection will occur at stent removal and 30 days post-insertion.
• Analysis will be conducted in a blinded manner.

Conclusions:

• The MAG-EX trial will provide crucial data to guide the selection of ureteric stents for post-ureteroscopy patients.
• Findings will inform clinicians, patients, and healthcare providers on the most suitable alternative stent type.
• This comparison aims to optimize patient care and reduce healthcare system burden associated with ureteric stents.