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

What this Trial Is About

Researchers are evaluating two different positions for performing extracorporeal shockwave lithotripsy (ESWL) to treat distal ureteric stones, which are stones located below the sacroiliac joint. ESWL is a common, non-invasive treatment that uses shockwaves to break up urinary stones. Traditionally, ESWL is done with patients lying face down (prone position), but some patients cannot tolerate this due to medical conditions like chronic obstructive pulmonary disease (COPD). This trial compares the traditional prone approach with a newer supine approach, where patients lie on their backs, to see which method leads to better stone clearance and fewer complications. The study is randomized and double-blinded, aiming to enroll 130 patients. The trial involves two groups: one receiving ESWL in the traditional prone position, with the shockwave generator placed on the abdomen, and the other receiving ESWL in the supine position, with the shockwave generator positioned at a 30-degree angle on the patient's buttock area to direct shockwaves via the sciatic foramina to the stone. ESWL is performed without sedation or anesthesia under fluoroscopy using a Dornier S2 lithotriptor. After treatment, patients are observed for two hours and given oral painkillers as needed. Follow-up includes kidney-ureter-bladder (KUB) X-rays at two weeks and monthly if necessary. If stones remain, additional ESWL sessions may be offered. Participants will be closely monitored with assessments for stone-free status at two, six, and ten weeks after treatment. Researchers will also track complications and pain associated with each ESWL approach. Patients can leave the study at any time and will continue usual care. The study duration varies by participant depending on response to treatment and follow-up results. Interim analyses will be conducted after half the patients are enrolled to review progress.

ESWL for Distal Ureteric Stone: Supine Versus Prone