ESWL for Distal Ureteric Stone: Supine Versus Prone

• ClinicalTrials.gov Identifier: NCT02298465
• Recruitment Status: Recruiting
• First Posted: November 24, 2014
• Last Update Posted: September 16, 2020
• Sponsor: Queen Mary Hospital, Hong Kong
• Information provided by (Responsible Party): Brian Ho, Queen Mary Hospital, Hong Kong

Tracking Information

• First Submitted Date: November 18, 2014
• First Posted Date: November 24, 2014
• Last Update Posted Date: September 16, 2020
• Study Start Date: November 2014
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2014)

Stone-free rate [ Time Frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks. ]

To review KUB to determine if distal ureteric stone have been passed

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2014)

• Complications rates concerning the two approaches of ESWL [ Time Frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks. ]
  To see if any complications arise from the procedures
• Pain associated with the procedure for the two approaches of ESWL [ Time Frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks. ]
  • 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Urinary Tract Stones
• Urinary Stones
• Urinary Calculi

Intervention

• Procedure: Supine 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.
• Procedure: Prone ESWL
  ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen
  Other Name: Transgluteal
• Device: Extracorporeal 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.

Study Arms

• Active Comparator: Prone ESWL
  ESWL for distal ureteric stone is performed in the traditional prone position
  Interventions:

  • Procedure: Prone ESWL
  • Device: Extracorporeal Shockwave Lithotripsy (ESWL)
• 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
  Interventions:

  • Procedure: Supine ESWL
  • Device: Extracorporeal Shockwave Lithotripsy (ESWL)

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 21, 2014): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2027
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Brian Ho, MBBS; (852)2255-3023; brianshho@gmail.com

Contact: Sau Loi Ng, BN, DN; (852)2255-3625; ngsauloi2009@gmail.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02298465
• Other Study ID Numbers: QueenMaryH
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Brian Ho, Queen Mary Hospital, Hong Kong
• Study Sponsor: Queen Mary Hospital, Hong Kong
• Collaborators: Not Provided

Investigators

• Principal Investigator: Brian Ho, MBBS; Queen Mary Hospital, Hong Kong

• PRS Account: Queen Mary Hospital, Hong Kong
• Verification Date: September 2020