Clinical trial NCT02298465: ESWL for Distal Ureteric Stone: Supine Versus Prone
Official title: Randomized Controlled Study on Extracorporeal Shockwave Lithotripsy for Distal Ureteric Stone: Transgluteal Versus Traditional Prone Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Tract Stones
Urinary Stones
Urinary Calculi
Keywords: ESWL
distal ureteric stone
transgluteal
supine ESWL
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who are unable to provide consent
* radiolucent stones
* active urinary tract infections
* pregnancy
* uncontrolled hypertension
* uncontrolled bleeding tendencies
* severe skeletal malformations
* arterial aneurysms within the vicinity of the stone (such as iliac artery aneurysms)
* unable to assume the appropriate position (prone or supine) for ESWL
* solitary kidneys
* transplanted kidneys
* presence of ureteric stents

Primary outcomes:
measure: Stone-free rate
timeFrame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Secondary outcomes:
measure: Complications rates concerning the two approaches of ESWL
timeFrame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
measure: Pain associated with the procedure for the two approaches of ESWL
timeFrame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Brian Ho, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jenkins AD, Gillenwater JY. Extracorporeal shock wave lithotripsy in the prone position: treatment of stones in the distal ureter or anomalous kidney. J Urol. 1988 May;139(5):911-5. doi: 10.1016/s0022-5347(17)42713-3.
citation: Zehntner CH, Marth D, Zingg EJ. ESWL treatment with ventral shock-wave application: therapy of iliac and distal ureteral calculi. Urology. 1991 Jul;38(1):51-3. doi: 10.1016/0090-4295(91)80013-w.
citation: Lu J, Sun X, He L. Sciaticum majus foramen and sciaticum minus foramen as the path of SWL in the supine position to treat distal ureteral stone. Urol Res. 2010 Dec;38(6):417-20. doi: 10.1007/s00240-010-0285-2. Epub 2010 Jul 13.
citation: Sun X, He L, Lu J, Cong X, Shen L, Wang Y, Zhu H. Greater and lesser ischiadic foramina as path of shock wave lithotripsy for distal ureteral stone in children. J Urol. 2010 Aug;184(2):665-8. doi: 10.1016/j.juro.2010.03.060. Epub 2010 Jun 19.
citation: Phipps S, Stephenson C, Tolley D. Extracorporeal shockwave lithotripsy to distal ureteric stones: the transgluteal approach significantly increases stone-free rates. BJU Int. 2013 Jul;112(2):E129-33. doi: 10.1111/j.1464-410X.2012.11738.x. Epub 2013 Jan 29.