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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All patients, over 18 years of age, with distal ureteric stones with stone size of ≥3mm on kidney-ureter-bladder (KUB) X-ray who opted for ESWL treatment

Locations
Other Locations
China
Queen Mary Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Brian Ho, MBBS
brianshho@gmail.com
(852)2255-3023
Backup
Sau Loi Ng, BN, DN
ngsauloi2009@gmail.com
(852)2255-3625
Time Frame
Start Date: 2014-11
Estimated Completion Date: 2027-11
Participants
Target number of participants: 130
Treatments
Active_comparator: Prone ESWL
ESWL for distal ureteric stone is performed in the traditional prone position
Experimental: Supine 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
Sponsors
Leads: Queen Mary Hospital, Hong Kong

This content was sourced from clinicaltrials.gov