An interventional study of Supine ESWL and Prone ESWL in Urinary Tract Stones, Urinary Stones and Urinary Calculi, sponsored by Queen Mary Hospital, Hong Kong. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by Queen Mary Hospital, Hong Kong · Not applicable, Interventional, and Treatment
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).
Previous authors have reported using the greater and lesser sciatic foramina as a pathway for the shockwaves to reach the distal ureter. No serious complications had developed in the patients who underwent transgluteal approach. Only minor complications such as self-limiting hematuria, dysuria, or pain that had responded to oral analgesics. 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 transgluteal ESWL for distal ureteric stones had an improved stone-free rate of 78% in the transgluteal group versus 40% in the prone group after one session of shockwave lithotripsy and a stone-free rate of 92% versus 63% respectively after two sessions of shockwave lithotripsy. This has been speculated to be due to the presence of bowel gas attenuating the shockwaves as well as a long skin-to-stone distance in the prone position.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 130 is close to the median of 120 across 61 interventional studies indexed under Urinary Calculi.
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ESWL for distal ureteric stone is performed in the traditional prone position
Procedure: Prone ESWL · Device: Extracorporeal Shockwave Lithotripsy (ESWL)
ESWL for distal ureteric stone is performed in the supine position, with the shockwave generator head placed at a 30 degree angle to the vertical at the patient's gluteal muscles. Thus, the shockwaves will travel via the greater and lesser sciatic foramina to reach the stone
Procedure: Supine ESWL · Device: Extracorporeal Shockwave Lithotripsy (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.
ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen
Also known as: Transgluteal
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.
Stone-free rate
To review KUB to determine if distal ureteric stone have been passed
Time frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Complications rates concerning the two approaches of ESWL
To see if any complications arise from the procedures
Time frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Pain associated with the procedure for the two approaches of ESWL
* Using visual analogue scale to determine the pain scores of each intervention on the day of intervention * Number of tablets of analgesics used in-between follow up
Time frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Plan to share: No
The record gives a start of Nov 2014, a primary completion of Nov 2025 and a completion of Nov 2027. It does not say whether these dates are actual or estimated.
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Queen Mary Hospital, Hong Kong