Urologic DiseasesNCT03388060
(SWL) Versus (ODT) Versus Combined SWL And ODT For Radiolucent Stone
A study testing Ultrasound guided SWL, Dissolution therapy and Combined ultrasound guided SWL and dissolution therapy in people with Urologic Diseases and Stone, Urinary, run by Mansoura University at 1 site in Egypt.
Trial summary
compare the efficacy of of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm renal stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Stone, Urinary, Stone, Kidney
- What is being tested?
- Ultrasound guided SWL, Dissolution therapy and Combined ultrasound guided SWL and dissolution therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 30 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
- Adult patient with 1-2.5 cm renal stones.
- Normal Serum creatinine
- Radiolucent stone by X-ray
Who cannot join
- Pregnancy.
- Bleeding diatheses.
- Patients with a pacemaker.
- Uncontrolled UTIs.
- Severe skeletal malformations.
- Severe obesity which prevent targeting of the stone; BMI (40 or more).
- Arterial aneurysm in the vicinity of the stone.
- Anatomical obstruction distal to the stone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shockwave Lithotripsy (SWL) Versus Oral Dissolution Therapy (ODT) Versus Combined SWL And ODT For Radiolucent Renal Stone Randomised Controlled Trial
compare the efficacy of of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm renal stones.
Read the detailed description
Urolithiasis is a common morbidity worldwide, affecting 10% to 15% of the population in Europe and North America. A higher prevalence of stone disease is found in hot or dry areas, including 20% to 25% in the Middle East. Radiolucent stones are mostly uric acid (UA) calculi, which varies geographically with worldwide incidence ranges from 5 to 40% and about 7- 10 percent of all calculi. Other rare radiolucent stones include xanthine and 2,8-dihydroxyadenine calculi.
The main etiologic factors for the development of uric acid nephrolithiasis are low urinary pH, hyperuricosuria, and low urinary volume. Practically, all of those who form uric acid stones have persistently low urinary pH, and most excrete normal amounts of uric acid. This suggests the potential importance of urinary pH manipulation in dissolving UA stones. Dissolution therapy for UA calculi is based on hydration and raising the urinary pH. European guidelines recommended that urine pH should be increased to a level above 6. The early published papers discussed the efficacy of oral chemo-dissolution therapy reporting high success rates. Since that era, there have been only a few publications, with widely variable results (15-80% complete dissolution rate).
Retrograde intrarenal surgery (RIRS), shockwave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL) are the three main non-medical modalities for treating medium-sized renal stones. Resorlu et al., retrospectively compare the outcomes of SWL, PNL, and RSIS for 10-20 mm radiolucent renal calculi of 437 patients and concluded that success rates "defined as stone-free status or asymptomatic insignificant residual fragments <3 mm." were 66.5, 91.4, and 87 % for SWL, PNL, and RIRS (p<0.001). in a prospective randomized of 135 patient with 1 to 2 cm radiolucent lower calyceal renal calculi, the 3-month stone-free rate of SWL, RIRS and miniperc was 73.8%, 86.1% and 95.1%, respectively (p =0.01).
Comparing the medical in the form of dissolution therapy versus non-medical in the form of SWL, Elderwy et al, in a prospective study on 87 children with radiolucent renal calculi with length less than 25 mm and a normal upper urinary tract or grade I HN, found that stone-free rate was 72.9% for dissolution therapy vs 82.1% after a single session of shock wave lithotripsy (p = 0.314).
Dissolution success is related to stone size as well as compliance. Larger stones demand longer therapy, and in these cases SWL may increase treatment efficacy by increasing stone surface area. So when Mokhless et al., use combined extracorporeal shock wave lithotripsy and dissolution therapy in radiolucent stone 12-65 mm in the largest diameter, stone-free rate of 100% was achieved in all 24 children after 3 months.9 To the best of our knowledge, there is no controlled trial comparing the efficacy of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm single renal stone.
- Conditions
- Urologic Diseases, Stone, Urinary, Stone, Kidney, ESWL, Radiolucent Calculus of Urinary Tract, Dissolution
- Being tested
- Ultrasound guided SWL, Dissolution therapy, Combined ultrasound guided SWL and dissolution therapy
- Keywords
- Oral Dissolution Therapy, Kidney stone, ESWL
- Medical subject headings
- Urologic Diseases, Urinary Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided SWLProcedure or surgery
Ultrasound guided SWL for radiolucent renal stone
Dissolution therapyProcedure or surgery
Alkalinization dissolution therapy for radiolucent renal stone
Combined ultrasound guided SWL and dissolution therapyProcedure or surgery
Combined ultrasound guided SWL and alkalinization dissolution therapy for radiolucent renal stone
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided SWL | Active comparator | ultrasound guided SWL for Radiolucent stone Receives: Procedure: Ultrasound guided SWL |
| Dissolution therapy | Active comparator | Dissolution therapy for Radiolucent stone Receives: Procedure: Dissolution therapy |
| Combined ultrasound guided SWL and dissolution therapy | Active comparator | Combined treatment for Radiolucent stone. Receives: Procedure: Combined ultrasound guided SWL and dissolution therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Free renal units from stones
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 posted2 Jan 2018
- Study start1 Apr 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelbaset, Mansoura University
- Investigators
- Khalid Sheir, MD, Study chair, Shock wave unit chief - Urology and nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388060
- Sponsor's protocol ID
- RL STONE
- Status last verified
- Aug 2018
- First submitted
- 23 Dec 2017
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Lithotripsy (SWL) Versus Oral Dissolution Therapy (ODT) Versus Combined SWL And ODT For Radiolucent Renal Stone Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03388060
- Acronym / sponsor ID
- RL STONE
- Conditions
- Urologic Diseases, Stone, Urinary, Stone, Kidney, ESWL, Radiolucent Calculus of Urinary Tract, Dissolution
- Keywords
- Oral Dissolution Therapy, Kidney stone, ESWL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 2 Jan 2018 (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 efficacy of of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm renal stones.
Detailed description
Urolithiasis is a common morbidity worldwide, affecting 10% to 15% of the population in Europe and North America. A higher prevalence of stone disease is found in hot or dry areas, including 20% to 25% in the Middle East. Radiolucent stones are mostly uric acid (UA) calculi, which varies geographically with worldwide incidence ranges from 5 to 40% and about 7- 10 percent of all calculi. Other rare radiolucent stones include xanthine and 2,8-dihydroxyadenine calculi.
The main etiologic factors for the development of uric acid nephrolithiasis are low urinary pH, hyperuricosuria, and low urinary volume. Practically, all of those who form uric acid stones have persistently low urinary pH, and most excrete normal amounts of uric acid. This suggests the potential importance of urinary pH manipulation in dissolving UA stones. Dissolution therapy for UA calculi is based on hydration and raising the urinary pH. European guidelines recommended that urine pH should be increased to a level above 6. The early published papers discussed the efficacy of oral chemo-dissolution therapy reporting high success rates. Since that era, there have been only a few publications, with widely variable results (15-80% complete dissolution rate).
Retrograde intrarenal surgery (RIRS), shockwave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL) are the three main non-medical modalities for treating medium-sized renal stones. Resorlu et al., retrospectively compare the outcomes of SWL, PNL, and RSIS for 10-20 mm radiolucent renal calculi of 437 patients and concluded that success rates "defined as stone-free status or asymptomatic insignificant residual fragments <3 mm." were 66.5, 91.4, and 87 % for SWL, PNL, and RIRS (p<0.001). in a prospective randomized of 135 patient with 1 to 2 cm radiolucent lower calyceal renal calculi, the 3-month stone-free rate of SWL, RIRS and miniperc was 73.8%, 86.1% and 95.1%, respectively (p =0.01).
Comparing the medical in the form of dissolution therapy versus non-medical in the form of SWL, Elderwy et al, in a prospective study on 87 children with radiolucent renal calculi with length less than 25 mm and a normal upper urinary tract or grade I HN, found that stone-free rate was 72.9% for dissolution therapy vs 82.1% after a single session of shock wave lithotripsy (p = 0.314).
Dissolution success is related to stone size as well as compliance. Larger stones demand longer therapy, and in these cases SWL may increase treatment efficacy by increasing stone surface area. So when Mokhless et al., use combined extracorporeal shock wave lithotripsy and dissolution therapy in radiolucent stone 12-65 mm in the largest diameter, stone-free rate of 100% was achieved in all 24 children after 3 months.9 To the best of our knowledge, there is no controlled trial comparing the efficacy of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm single renal stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided SWL | Active comparator | Procedure: Ultrasound guided SWLultrasound guided SWL for Radiolucent stone |
| Dissolution therapy | Active comparator | Procedure: Dissolution therapyDissolution therapy for Radiolucent stone |
| Combined ultrasound guided SWL and dissolution therapy | Active comparator | Procedure: Combined ultrasound guided SWL and dissolution therapyCombined treatment for Radiolucent stone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient with 1-2.5 cm renal stones.
- Normal Serum creatinine
- Radiolucent stone by X-ray
Key exclusion criteria (8 listed)
- Pregnancy.
- Bleeding diatheses.
- Patients with a pacemaker.
- Uncontrolled UTIs.
- Severe skeletal malformations.
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 |
|---|---|---|
| Ultrasound guided SWLUltrasound guided SWL for radiolucent renal stone | Procedure or surgery | Ultrasound guided SWL |
| Dissolution therapyAlkalinization dissolution therapy for radiolucent renal stone | Procedure or surgery | Dissolution therapy |
| Combined ultrasound guided SWL and dissolution therapyCombined ultrasound guided SWL and alkalinization dissolution therapy for radiolucent renal stone | Procedure or surgery | Combined ultrasound guided SWL and dissolution therapy |
Primary outcome
Stone free rate
Time frame: 3 months
Free renal units from stones
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
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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.
Khalid Sheir, MD study chair
Shock wave unit chief - Urology and nephrology center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided SWL, Dissolution therapy and Combined ultrasound guided SWL and dissolution therapy in people with Urologic Diseases and Stone, Urinary, 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 3 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: finished, as of the sponsor's last update on 6 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2018.