📃 Paper Title: Shockwave Lithotripsy versus Ureteroscopic Treatment as Therapeutic Interventions for Stones of the Ureter (TISU): A Multicentre Randomised Controlled Non-inferiority Trial
🧍 Author: Ranan Dasgupta
🕒 Year: 2021
📚 Journal: European Urology
🌎 Country: UK
ㅤContext to the study:
Can you tell me about a study that compared shockwave lithotripsy with ureteroscopy for treatment of ureteric stones?
ㅤ✅ Take-home message of study:
The proportion of patients who need re-intervention for the management of ureteric stones is 12% higher in those treated with SWL compared to URS at 6 months (22% for SWL vs 10% for URS)
SWL considered "non-inferior" as difference of 12% was less than predefined threshold of 20%
There were similar levels of serious adverse events when comparing SWL and URS for ureteric stone management at 6 months (4% for SWL vs 3% for URS)
The shockwave lithotripsy pathway is more cost-effective in an NHS setting, but results in lower quality of life.
ㅤ Randomised Controlled Trial: Multicentre (n=25), non-inferiority design
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Study participants:
Total participants = 613
Inclusion criteria:
Single ureteric stone requiring intervention- any part of ureter
Clinical suitability for either SWL or ureteroscopy (URS)
CTKUB confirmed diagnosis
Age >=16 years
Intervention and Comparison:
Shock wave lithotripsy (n=306)
Up to two sessions with fixed site lithotripter
Ureteroscopy (n=307)
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Key study outcomes:
Patients follow up at 6 months:
Proportion of patients needing further intervention to clear stone:
SWL = 22%
URS = 10%
Serious complication rate (defined as Clavien-Dindo level >=3)
SWL = 4%
URS = 3%
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Study Limitations:
Low return and completion rates of patient questionnaires.
The study was initially powered for 500 patients in each arm - and each arm only recruited approx 300 patients each. A trial of 450 participants per arm was required for the lower bound of the estimated 95% CI to exclude -20%, with 90% power.
Primary clinical outcome measure was resolution of the stone episode (stone clearance), which was operationally defined as 'no further intervention required to facilitate stone clearance' - as opposed to reimaging
As per intention to treat analysis:
A significant proportion of patients received a different treatment to the group in which they were analysed
Patients who had passed their stone were included in the analysis (even where they did not receive any intervention)
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