Urologic DiseasesNCT03243682
The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones
A study testing Bidirectional Shock Wave Lithotripsy and Standard Shock Wave Lithotripsy in people with Urologic Diseases and Stones, Kidney, run by Mansoura University at 1 site in Egypt.
Trial summary
compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating bidirectional approach versus the standard approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Stones, Kidney, Stone, Urinary
- What is being tested?
- Bidirectional Shock Wave Lithotripsy and Standard Shock Wave Lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2016to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient criteria:
- Ability to give informed consent.
- Normal laboratory profile as regarding serum creatinine, liver function, platelets count and prothrombin time.
- Stone criteria:
- Single renal stone less than two cm or upper lumbar ureteric stone less than one cm.
- Radio-opaque stones.
Who cannot join
- Bleeding tendency.
- Poor kidney function.
- Pregnancy.
- Abdominal aortic aneurysm.
- Indwelling DJ ureteric stent or percutaneous nephrostomy tube (PCN).
- Congenital anomalies of the urinary tract.
- Untreated urinary tract infection.
- Obstructed urinary tract distal to the stone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones. A Randomized Clinical Trial
compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating bidirectional approach versus the standard approach.
Read the detailed description
Shock wave lithotripsy (SWL) has been considered the preferred method for treating upper urinary tract stones since 1980s due to its minimally invasive characters and low morbidity. The overall stone free rates have been reported to be 80% to 90% .
In the presence of pregnancy, untreated urinary tract infection, decompensated coagulopathy, uncontrolled arrhythmia and abdominal aortic aneurysm, other treatment methods should be considered .
SWL is associated with some complications. The most common complications of SWL are renal colic (40%), gross hematuria (32%), urinary obstruction (30.9%), symptomatic bacteriuria (9.7%) and perirenal hematoma or subclinical subcapsular hematoma (4.6%).
There are many factors affecting the success of SWL as patient age, sex, body mass index (BMI), stone size, site and number, radiological renal features, congenital renal anomalies and presence of double-J (DJ) ureteric stent .
Regarding the renal stones, stones smaller than 10 mm had a success rate of 90%, while those larger than 10 mm had a success rate of 70%. Stones located in the renal pelvis and upper pole had a success rate of 87.3 and 88.5% respectively, while those located in the lower pole had a success rate of 69.5%. A single renal stone had a 78.3% success rate compared to 62.8% in multiple renal stones . Regarding the ureteric stones, stone size more than 10 mm was one of the strongest independent predictors of failure of SWL
Patients appear to have the best chance for successful SWL when they have small BMI and their stones are single and located in the renal pelvis . Skin to stone distance (SSD) measured by non-contrast computerized tomography scan (NCCT) has a significant role in the treatment of renal stones using SWL. Slow shock wave rate (60/min) is associated with increase in the success rate and decrease in pain, complication and number of session to achieve success when compared to rapid shock wave rate (120/min)
Some techniques were developed to increase the efficacy of SWL. In 1999, the bidirectional synchronous twin-pulse technique with variable angles between the shock wave reflectors was developed and it improved the quality and rate of stone disintegration in vitro and it was more effective than the traditional single generator and also it decreases the overall treatment times
The TWINHEADS 101 lithotripter comprises two identical under and over table reflectors to permit synchronous shock waves emission from two perpendicular directions to the same focal point. This technique intensifies and localizes the cavitations effects by the interacting focal zones of both reflectors, resulting in a better quality and rate of stone disintegration, especially with a right angle between the axes of the reflectors.
The first prospective clinical study was done in 2005 regarding synchronous twin-pulse SWL and it seems safe and effective for treating patients with renal and upper ureteric stones. The stone-free rate was 74% after one session and 100% after two sessions within a month
Based on the principle of the TWINHEADS lithotripter, we will use Dornier Gemini lithotripter to emit the shock waves from two different directions to the same focal point asynchronously for renal and upper lumbar ureteric stones.
- Being tested
- Bidirectional Shock Wave Lithotripsy, Standard Shock Wave Lithotripsy
- Keywords
- Shock wave lithotripsy, Bidirectional, Stones
- Medical subject headings
- Urologic Diseases, Kidney Calculi, Urinary Calculi, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bidirectional Shock Wave LithotripsyProcedure or surgery
Also called Bidirectional SWL
the alternating bidirectional (under and over table) approach during SWL for renal and upper lumbar ureteric stones
Standard Shock Wave LithotripsyProcedure or surgery
Also called Standard SWL
the standard unidirectional approach during SWL for renal and upper lumbar ureteric stones
| Study group | Role | What they receive |
|---|---|---|
| Bidirectional Shock Wave Lithotripsy | Active comparator | alternating bidirectional (under and over table) approach Receives: Procedure: Bidirectional Shock Wave Lithotripsy |
| Standard Shock Wave Lithotripsy | Active comparator | standard unidirectional approach Receives: Procedure: Standard Shock Wave Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate three months after the last session
residual less than 4 mm by non-contrast computerized tomography scan (NCCT)
Measured: 18 months
Secondary outcomes (1)
severity of complications after SWL in both groups
Clavien-Dindo scale of surgical complications
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Sep 2016
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies 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
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahamed Hegazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243682
- Sponsor's protocol ID
- Bidirectional SWL
- Status last verified
- Jul 2017
- First submitted
- 29 Jul 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hegazy M, El-Assmy A, Ali-El-Dein B, Sheir KZ. The alternating bidirectional versus the standard approach during shock wave lithotripsy for upper lumbar ureteric stones: a randomized controlled trial. World J Urol. 2021 Jan;39(1):247-253. doi: 10.1007/s00345-020-03148-5. Epub 2020 Mar 23.
PubMed 32206888
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03243682
- Acronym / sponsor ID
- Bidirectional SWL
- Keywords
- Shock wave lithotripsy, Bidirectional, Stones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 9 Aug 2017 (actual)
- 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.
compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating bidirectional approach versus the standard approach.
Detailed description
Shock wave lithotripsy (SWL) has been considered the preferred method for treating upper urinary tract stones since 1980s due to its minimally invasive characters and low morbidity. The overall stone free rates have been reported to be 80% to 90% .
In the presence of pregnancy, untreated urinary tract infection, decompensated coagulopathy, uncontrolled arrhythmia and abdominal aortic aneurysm, other treatment methods should be considered .
SWL is associated with some complications. The most common complications of SWL are renal colic (40%), gross hematuria (32%), urinary obstruction (30.9%), symptomatic bacteriuria (9.7%) and perirenal hematoma or subclinical subcapsular hematoma (4.6%).
There are many factors affecting the success of SWL as patient age, sex, body mass index (BMI), stone size, site and number, radiological renal features, congenital renal anomalies and presence of double-J (DJ) ureteric stent .
Regarding the renal stones, stones smaller than 10 mm had a success rate of 90%, while those larger than 10 mm had a success rate of 70%. Stones located in the renal pelvis and upper pole had a success rate of 87.3 and 88.5% respectively, while those located in the lower pole had a success rate of 69.5%. A single renal stone had a 78.3% success rate compared to 62.8% in multiple renal stones . Regarding the ureteric stones, stone size more than 10 mm was one of the strongest independent predictors of failure of SWL
Patients appear to have the best chance for successful SWL when they have small BMI and their stones are single and located in the renal pelvis . Skin to stone distance (SSD) measured by non-contrast computerized tomography scan (NCCT) has a significant role in the treatment of renal stones using SWL. Slow shock wave rate (60/min) is associated with increase in the success rate and decrease in pain, complication and number of session to achieve success when compared to rapid shock wave rate (120/min)
Some techniques were developed to increase the efficacy of SWL. In 1999, the bidirectional synchronous twin-pulse technique with variable angles between the shock wave reflectors was developed and it improved the quality and rate of stone disintegration in vitro and it was more effective than the traditional single generator and also it decreases the overall treatment times
The TWINHEADS 101 lithotripter comprises two identical under and over table reflectors to permit synchronous shock waves emission from two perpendicular directions to the same focal point. This technique intensifies and localizes the cavitations effects by the interacting focal zones of both reflectors, resulting in a better quality and rate of stone disintegration, especially with a right angle between the axes of the reflectors.
The first prospective clinical study was done in 2005 regarding synchronous twin-pulse SWL and it seems safe and effective for treating patients with renal and upper ureteric stones. The stone-free rate was 74% after one session and 100% after two sessions within a month
Based on the principle of the TWINHEADS lithotripter, we will use Dornier Gemini lithotripter to emit the shock waves from two different directions to the same focal point asynchronously for renal and upper lumbar ureteric stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bidirectional Shock Wave Lithotripsy | Active comparator | Procedure: Bidirectional Shock Wave Lithotripsyalternating bidirectional (under and over table) approach |
| Standard Shock Wave Lithotripsy | Active comparator | Procedure: Standard Shock Wave Lithotripsystandard unidirectional approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient criteria:
- Stone criteria:
Key exclusion criteria (8 listed)
- Bleeding tendency.
- Poor kidney function.
- Pregnancy.
- Abdominal aortic aneurysm.
- Indwelling DJ ureteric stent or percutaneous nephrostomy tube (PCN).
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 |
|---|---|---|
| Bidirectional Shock Wave LithotripsyAlso: Bidirectional SWLthe alternating bidirectional (under and over table) approach during SWL for renal and upper lumbar ureteric stones | Procedure or surgery | Bidirectional Shock Wave Lithotripsy |
| Standard Shock Wave LithotripsyAlso: Standard SWLthe standard unidirectional approach during SWL for renal and upper lumbar ureteric stones | Procedure or surgery | Standard Shock Wave Lithotripsy |
Primary outcome
stone free rate three months after the last session
Time frame: 18 months
residual less than 4 mm by non-contrast computerized tomography scan (NCCT)
1 secondary outcome
severity of complications after SWL in both groups
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Derived from this study: PubMed 32206888Hegazy M, El-Assmy A, Ali-El-Dein B, Sheir KZ. The alternating bidirectional versus the standard approach during shock wave lithotripsy for upper lumbar ureteric stones: a randomized controlled trial. World J Urol. 2021 Jan;39(1):247-253. doi: 10.1007/s00345-020-03148-5. Epub 2020 Mar 23.
Related trials for Urologic Diseases
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingObservational study
Study of Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
RecruitingObservational study
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Bladder Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bidirectional Shock Wave Lithotripsy and Standard Shock Wave Lithotripsy in people with Urologic Diseases and Stones, Kidney, run by Mansoura University at 1 site in Egypt.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Aug 2017. 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 Egypt. 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?
Results are not available in the source record.
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?
stone free rate three months after the last session (time frame: 18 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 NCT03243682, 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 9 Aug 2017.