Kidney StoneNCT01852669
Adjunct Inversion for Lower Pole Stone
A study testing Inversion, Shock Wave Lithotripsy and Hydration in people with Kidney Stone, run by Monash University.
Trial summary
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Inversion, Shock Wave Lithotripsy and Hydration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solitary lower pole caliceal stone which is > 5 mm and < 20mm
- Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
- Patient able to comply strictly with visits/medications
- Patient willing and agrees to enter study
Who cannot join
- Impaired function of the affected kidney
- Gross hydronephrosis of the affected kidney
- Associated distal obstruction
- Multiple stones
- Stone more than 2 cm in size
- Diverticular stone
Show all 10Show fewer
- Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
- Patients who are unable to tolerate the procedure
- Significant cardiac condition that does not allow the administration of force hydration or inversion.
- Uncontrolled hypertension
About this study
Official title: A Prospective, Randomized, Double Blind, Controlled Study Comparing Extracorporeal Shock Wave Lithotripsy (ESWL) With and Without Simultaneous Adjunct Controlled Inversion Therapy in the Treatment of Lower Pole Caliceal Stone
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.
- Conditions
- Kidney Stone
- Being tested
- Inversion, Shock Wave Lithotripsy, Hydration
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InversionProcedure or surgery
Patients inverted 30 degree head down in Trendelenburg position
Shock Wave LithotripsyProcedure or surgery
Also called ESWL
Shock wave lithotripsy
HydrationDrug
Also called Frusemide 20mg
Hydration of patient with 0.5L NaCl and 20mg frusemide IV
| Study group | Role | What they receive |
|---|---|---|
| Inversion, Hydration, ESWL | Experimental | ESWL with hydration and inversion Receives: Procedure: Inversion; Procedure: Shock Wave Lithotripsy; Drug: Hydration |
| ESWL, Hydration | Active comparator | ESWL with hydration Receives: Procedure: Shock Wave Lithotripsy; Drug: Hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Are Stone Free at 3 Months
To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startJan 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies 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
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Lam Wah Ee Hospital
- Responsible party
- Principal investigator, Shaun Lee Wen Huey, Monash University
- Investigators
- Liong Men Long, MBBS, Principal investigator, Lam Wah Ee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852669
- Sponsor's protocol ID
- LPS001
- Status last verified
- Apr 2015
- First submitted
- 2 May 2013
- Last updated
- 20 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Leong WS, Liong ML, Liong YV, Wu DB, Lee SW. Does simultaneous inversion during extracorporeal shock wave lithotripsy improve stone clearance: a long-term, prospective, single-blind, randomized controlled study. Urology. 2014 Jan;83(1):40-4. doi: 10.1016/j.urology.2013.08.004. Epub 2013 Sep 14.
PubMed 24044912
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind, Controlled Study Comparing Extracorporeal Shock Wave Lithotripsy (ESWL) With and Without Simultaneous Adjunct Controlled Inversion Therapy in the Treatment of Lower Pole Caliceal Stone
- ClinicalTrials.gov ID
- NCT01852669
- Acronym / sponsor ID
- LPS001
- Conditions
- Kidney Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Lam Wah Ee Hospital
- Study start
- Jan 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Posted 20 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inversion, Hydration, ESWL | Experimental | Procedure: Inversion, Procedure: Shock Wave Lithotripsy, Drug: HydrationESWL with hydration and inversion |
| ESWL, Hydration | Active comparator | Procedure: Shock Wave Lithotripsy, Drug: HydrationESWL with hydration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Solitary lower pole caliceal stone which is > 5 mm and < 20mm
- Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
- Patient able to comply strictly with visits/medications
- Patient willing and agrees to enter study
Key exclusion criteria (10 listed)
- Impaired function of the affected kidney
- Gross hydronephrosis of the affected kidney
- Associated distal obstruction
- Multiple stones
- Stone more than 2 cm in size
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 |
|---|---|---|
| InversionPatients inverted 30 degree head down in Trendelenburg position | Procedure or surgery | Inversion, Hydration, ESWL |
| Shock Wave LithotripsyAlso: ESWLShock wave lithotripsy | Procedure or surgery | ESWL, Hydration, Inversion, Hydration, ESWL |
| HydrationAlso: Frusemide 20mgHydration of patient with 0.5L NaCl and 20mg frusemide IV | Drug | ESWL, Hydration, Inversion, Hydration, ESWL |
Primary outcome
Number of Participants Who Are Stone Free at 3 Months
Time frame: 3 months
To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24044912Leong WS, Liong ML, Liong YV, Wu DB, Lee SW. Does simultaneous inversion during extracorporeal shock wave lithotripsy improve stone clearance: a long-term, prospective, single-blind, randomized controlled study. Urology. 2014 Jan;83(1):40-4. doi: 10.1016/j.urology.2013.08.004. Epub 2013 Sep 14.
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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. This study is not recruiting at the moment.
Liong Men Long, MBBS principal investigator
Lam Wah Ee Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Inversion, Shock Wave Lithotripsy and Hydration in people with Kidney Stone, run by Monash University.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Are Stone Free at 3 Months (time frame: 3 months). 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 NCT01852669, which also lists 1 linked publication.
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 20 Apr 2015.