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ESWL for Distal Ureteric Stone: Supine Versus Prone

Primary Purpose

Urinary Tract Stones, Urinary Stones, Urinary Calculi

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Supine ESWL
Prone ESWL
Extracorporeal Shockwave Lithotripsy (ESWL)
Sponsored by
Queen Mary Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Stones focused on measuring ESWL, distal ureteric stone, transgluteal, supine ESWL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prone ESWL

Supine ESWL

Arm Description

ESWL for distal ureteric stone is performed in the traditional prone position

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

Outcomes

Primary Outcome Measures

Stone-free rate
To review KUB to determine if distal ureteric stone have been passed

Secondary Outcome Measures

Complications rates concerning the two approaches of ESWL
To see if any complications arise from the procedures
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

Full Information

First Posted
November 18, 2014
Last Updated
August 8, 2023
Sponsor
Queen Mary Hospital, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02298465
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Mary Hospital, Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Stones, Urinary Stones, Urinary Calculi
Keywords
ESWL, distal ureteric stone, transgluteal, supine ESWL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prone ESWL
Arm Type
Active Comparator
Arm Description
ESWL for distal ureteric stone is performed in the traditional prone position
Arm Title
Supine ESWL
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Supine ESWL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prone ESWL
Other Intervention Name(s)
Transgluteal
Intervention Description
ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shockwave Lithotripsy (ESWL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stone-free rate
Description
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.
Secondary Outcome Measure Information:
Title
Complications rates concerning the two approaches of ESWL
Description
To see if any complications arise from the procedures
Time Frame
2 weeks. If stone still present, then 6 weeks and 10 weeks.
Title
Pain associated with the procedure for the two approaches of ESWL
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Ho, MBBS
Phone
(852)2255-3023
Email
brianshho@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sau Loi Ng, BN, DN
Phone
(852)2255-3625
Email
ngsauloi2009@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Ho, MBBS
Organizational Affiliation
Queen Mary Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Ho, MBBS, FCSHK
Phone
(852)2255-3023
Email
brianshho@gmail.com
First Name & Middle Initial & Last Name & Degree
Sau Loi Ng, BN, DN
Phone
(852)2255-3625
Email
ngsauloi2009@gmail.com
First Name & Middle Initial & Last Name & Degree
Jason Wong, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3361661
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.
Results Reference
background
PubMed Identifier
1866859
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.
Results Reference
background
PubMed Identifier
20625895
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.
Results Reference
background
PubMed Identifier
20639031
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.
Results Reference
background
PubMed Identifier
23360696
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.
Results Reference
background

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ESWL for Distal Ureteric Stone: Supine Versus Prone

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