RecruitingNot ApplicableNCT02298465

ESWL for Distal Ureteric Stone: Supine Versus Prone

Randomized Controlled Study on Extracorporeal Shockwave Lithotripsy for Distal Ureteric Stone: Transgluteal Versus Traditional Prone Approach


Sponsor

Queen Mary Hospital, Hong Kong

Enrollment

130 participants

Start Date

Nov 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

Extracorporeal shockwave lithotripsy (ESWL) for urinary stone is common and widespread nowadays. Approximately 80% of urinary stones are treated by ESWL. Traditionally distal ureteric stones are treated with ESWL in the prone position. However, as some patients cannot tolerate lying in the prone due to medical illness such as chronic obstructive pulmonary disease (COPD), some authors have reported using the supine approach of ESWL for treatment of distal ureter stones. No serious complications had developed in the patients who underwent supine approach. Only minor complications such as self-limiting blood in the urine, painful passage of urine, or local pain that had responded to oral painkillers. There were no serious complications encountered in children as well. In the most recent retrospective review by Tolley et al, they had revealed that patients who had underwent supine ESWL for distal ureteric stones had an improved stone-free rate compared with the traditional prone approach. Patient with radio-opaque distal ureteric stones (stones below the sacroiliac joint) on KUB X-ray, who have opted for ESWL treatment, are randomized into two groups: one undergoing ESWL in the supine position and the other undergoing ESWL in the prone position. Patients will be observed for two hours after ESWL before being discharged. Oral painkillers as necessary will be provided to the patient. The patients will have a KUB Xray at 2 weeks post-ESWL, and then monthly afterwards if required. If there are residual stones at the 2-week follow-up, the patient will be offered ESWL again. Patients are free to withdraw from the study at any time and will continue to be managed as per usual. The investigators aim to have 130 patients, with 65 patients in each group with an interim analyses to be performed when 66 patients have been recruited (33 patients in each group).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two positions — lying on your back (supine) versus lying face-down (prone) — for a procedure called Extracorporeal Shock Wave Lithotripsy (ESWL), which uses sound waves to break up kidney stones in the lower ureter. Researchers want to find out which position leads to better stone clearance and fewer complications. You may be eligible if... - You are 18 years of age or older - You have a stone in the lower ureter that is 3mm or larger, visible on X-ray - You have chosen ESWL as your treatment method You may NOT be eligible if... - You cannot give consent - Your stone is radiolucent (not visible on X-ray) - You have an active urinary tract infection - You are pregnant - You have uncontrolled high blood pressure or bleeding problems - You have severe skeletal deformities or arterial aneurysms near the stone - You cannot assume the required treatment position - You have a solitary or transplanted kidney - You have a ureteric stent in place Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESupine ESWL

ESWL to distal ureteric stone is performed in the supine position with the shockwave generator placed in the patient's buttock area. The aim is to direct the shockwaves through the greater and lesser sciatic foramina to reach the distal ureter.

PROCEDUREProne ESWL

ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen

DEVICEExtracorporeal Shockwave Lithotripsy (ESWL)

The ESWL machine we use is the Dornier S2 lithotriptor. ESWL is performed without any sedation or anesthesia under fluoroscopy. Painkillers are given upon request.


Locations(1)

Queen Mary Hospital

Hong Kong, China

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NCT02298465


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