Urinary Tract StonesNCT02298465
ESWL for Distal Ureteric Stone: Supine Versus Prone
A study testing Supine ESWL, Prone ESWL and Extracorporeal Shockwave Lithotripsy (ESWL) in people with Urinary Tract Stones and Urinary Stones, run by Queen Mary Hospital, Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Stones, Urinary Stones, Urinary Calculi
- What is being tested?
- Supine ESWL, Prone ESWL and Extracorporeal Shockwave Lithotripsy (ESWL)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are unable to provide consent
- radiolucent stones
- active urinary tract infections
- pregnancy
- uncontrolled hypertension
- uncontrolled bleeding tendencies
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Brian Ho, MBBS, FCSHK, (852)2255-3023, brianshho@gmail.com
Sau Loi Ng, BN, DN, (852)2255-3625, ngsauloi2009@gmail.com
About this study
Official title: Randomized Controlled Study on Extracorporeal Shockwave Lithotripsy for Distal Ureteric Stone: Transgluteal Versus Traditional Prone Approach
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).
Read the 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.
- Conditions
- Urinary Tract Stones, Urinary Stones, Urinary Calculi
- Being tested
- Supine ESWL, Prone ESWL, Extracorporeal Shockwave Lithotripsy (ESWL)
- Keywords
- ESWL, distal ureteric stone, transgluteal, supine ESWL
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine ESWLProcedure or surgery
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.
Prone ESWLProcedure or surgery
Also called Transgluteal
ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen
Extracorporeal Shockwave Lithotripsy (ESWL)Device
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 group | Role | What they receive |
|---|---|---|
| Prone ESWL | Active comparator | ESWL for distal ureteric stone is performed in the traditional prone position Receives: Procedure: Prone ESWL; Device: Extracorporeal Shockwave Lithotripsy (ESWL) |
| Supine ESWL | Experimental | 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 Receives: Procedure: Supine ESWL; Device: Extracorporeal Shockwave Lithotripsy (ESWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
To review KUB to determine if distal ureteric stone have been passed
Measured: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Secondary outcomes (2)
Complications rates concerning the two approaches of ESWL
To see if any complications arise from the procedures
Measured: 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
Measured: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Ho, Queen Mary Hospital, Hong Kong
- Investigators
- Brian Ho, MBBS, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298465
- Sponsor's protocol ID
- QueenMaryH
- Status last verified
- Aug 2023
- First submitted
- 18 Nov 2014
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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. doi: 10.1016/s0022-5347(17)42713-3.
PubMed 3361661Zehntner 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.
PubMed 1866859Lu 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.
PubMed 20625895Sun 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.
PubMed 20639031Phipps 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.
PubMed 23360696
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on Extracorporeal Shockwave Lithotripsy for Distal Ureteric Stone: Transgluteal Versus Traditional Prone Approach
- ClinicalTrials.gov ID
- NCT02298465
- Acronym / sponsor ID
- QueenMaryH
- Conditions
- Urinary Tract Stones, Urinary Stones, Urinary Calculi
- Keywords
- ESWL, distal ureteric stone, transgluteal, supine ESWL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone ESWL | Active comparator | Procedure: Prone ESWL, Device: Extracorporeal Shockwave Lithotripsy (ESWL)ESWL for distal ureteric stone is performed in the traditional prone position |
| Supine ESWL | Experimental | Procedure: Supine 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (12 listed)
- Patients who are unable to provide consent
- radiolucent stones
- active urinary tract infections
- pregnancy
- uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine ESWLESWL 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 or surgery | Supine ESWL |
| Prone ESWLAlso: TransglutealESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen | Procedure or surgery | Prone ESWL |
| 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. | Device | Prone ESWL, Supine ESWL |
Primary outcome
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
2 secondary outcomes
Complications rates concerning the two approaches of ESWL
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
Time frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 3361661Jenkins 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.
- Background: PubMed 1866859Zehntner 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.
- Background: PubMed 20625895Lu 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.
- Background: PubMed 20639031Sun 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.
- Background: PubMed 23360696Phipps 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Ho, MBBS principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine ESWL, Prone ESWL and Extracorporeal Shockwave Lithotripsy (ESWL) in people with Urinary Tract Stones and Urinary Stones, run by Queen Mary Hospital, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Ho, MBBS ((852)2255-3023, brianshho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (time frame: 2 weeks. If stone still present, then 6 weeks and 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298465, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.