Oral Dissolution TherapyNCT06814834
The Efficacy of Oral Dissolution Therapy (ODT), Extracorporeal Shock Wave Lithotripsy (ESWL), and Combined ESWL and ODT as Non-Invasive Modalities for Treating Small and Medium-Sized Radiolucent Renal Stones
A study testing Oral dissolution therapy, Extracorporeal shock wave lithotripsy and Oral dissolution therapy + extracorporeal shock wave lithotripsy in people with Oral Dissolution Therapy and Extracorporeal Shock Wave Lithotripsy, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to compare oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), and a combination of ESWL and ODT as noninvasive modalities for treating small and medium-sized renal radiolucent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Dissolution Therapy, Extracorporeal Shock Wave Lithotripsy, Noninvasive
- What is being tested?
- Oral dissolution therapy, Extracorporeal shock wave lithotripsy and Oral dissolution therapy + extracorporeal shock wave lithotripsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 20 Dec 2024
- 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
- Age ≥ 18 years.
- Both sexes.
- Patients with a single radiolucent renal stone 0.5-2 cm at largest diameter diagnosed by non-contrast MSCT of the urinary tract (CTUT) ≤ 500 HU (Hounsfield Unit) and not seen on kidney, ureter, and bladder (KUB) X-ray.
Who cannot join
- Patients with Coagulation disorders, a pacemaker, severe deformity of the skeletal system, anatomical obstruction distal to the stone, and obesity (Body Mass Index more than or equal to 35 kilograms per meter square).
- Patients with renal insufficiency (creatinine more than 1.7 mg/dl).
- Patients with active urinary tract infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Compare the Efficacy of Oral Dissolution Therapy (ODT), Extracorporeal Shock Wave Lithotripsy (ESWL), and Combined ESWL and ODT as Non-Invasive Modalities for Treating Small and Medium-Sized Radiolucent Renal Stones
This study aimed to compare oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), and a combination of ESWL and ODT as noninvasive modalities for treating small and medium-sized renal radiolucent.
Read the detailed description
Various methods exist for managing small and medium-sized radiolucent renal stones. These range from observation to oral dissolution therapy (ODT), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL).
Oral dissolving therapy diminishes the recurrence rates of stones. It positively influences the medical management of stone activity following ESWL in cases with residual calculi. By integrating oral dissolution therapy with extracorporeal shock wave lithotripsy, cases may experience the advantages of both non-invasive techniques. The combination of oral dissolution therapy and ESWL is an efficient therapeutic modality for radiolucent renal stones, dramatically reducing the overall stone volume. It also reduces the frequency of necessary extracorporeal shock wave lithotripsy sessions compared to treatment with ESWL alone
- Conditions
- Oral Dissolution Therapy, Extracorporeal Shock Wave Lithotripsy, Noninvasive, Small, Medium, Radiolucent Renal Stones
- Being tested
- Oral dissolution therapy, Extracorporeal shock wave lithotripsy, Oral dissolution therapy + extracorporeal shock wave lithotripsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral dissolution therapyDrug
Patients received guidance for oral potassium-sodium-hydrogen-citrate (6:6:3:5) at a dosage of twenty milliequivalents three times every day, along with a daily fluid intake of two to three liters and a food plan to restrict protein and sodium consumption for a maximum of three months.
Extracorporeal shock wave lithotripsyProcedure or surgery
Patients received extracorporeal shock wave lithotripsy utilizing a Dornier lithotripter equipped with an integrated ultrasound for stone localization. If the patient required additional sessions, up to a maximum of four sessions, at a rate of 60-90 shocks per minute, the period between sessions was three weeks.
Oral dissolution therapy + extracorporeal shock wave lithotripsyProcedure or surgery
Patients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| Oral dissolution therapy group | Active comparator | Patients received guidance for oral potassium-sodium-hydrogen-citrate (6:6:3:5) at a dosage of twenty milliequivalents three times every day, along with a daily fluid intake of two to three liters and a food plan to restrict protein and sodium consumption for a maximum of three months. Receives: Drug: Oral dissolution therapy |
| Extracorporeal shock wave lithotripsy group | Experimental | Patients received extracorporeal shock wave lithotripsy utilizing a Dornier lithotripter equipped with an integrated ultrasound for stone localization. If the patient required additional sessions, up to a maximum of four sessions, at a rate of 60-90 shocks per minute, the period between sessions was three weeks. Receives: Procedure: Extracorporeal shock wave lithotripsy |
| Oral dissolution therapy + extracorporeal shock wave lithotripsy group | Experimental | Patients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy. Receives: Procedure: Oral dissolution therapy + extracorporeal shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free status
To assess the stone-free status, which is characterized by no evidence of any residual stones in renal units by MSCT of the urinary tract (CTUT) at 3 months following oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), or combined ODT and ESWL.
Measured: 3 months after the procedure
Secondary outcomes (1)
Complication rate
The complication rate of extracorporeal shock wave lithotripsy (ESWL) as hematuria, perinephric hematoma, renal colics, steinstrasse fragments, gastrointestinal tract upset, number of sessions needed, and the essential for auxiliary processes following 3 months as ureteroscopy (URS), Flexible URS, or percutaneous nephrolithotomy (PCNL).
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start20 Dec 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Dissolution TherapyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ateya, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814834
- Sponsor's protocol ID
- MS-556-2023
- Status last verified
- Feb 2025
- First submitted
- 22 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Compare the Efficacy of Oral Dissolution Therapy (ODT), Extracorporeal Shock Wave Lithotripsy (ESWL), and Combined ESWL and ODT as Non-Invasive Modalities for Treating Small and Medium-Sized Radiolucent Renal Stones
- ClinicalTrials.gov ID
- NCT06814834
- Acronym / sponsor ID
- MS-556-2023
- Conditions
- Oral Dissolution Therapy, Extracorporeal Shock Wave Lithotripsy, Noninvasive, Small, Medium, Radiolucent Renal Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 7 Feb 2025 (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.
This study aimed to compare oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), and a combination of ESWL and ODT as noninvasive modalities for treating small and medium-sized renal radiolucent.
Detailed description
Various methods exist for managing small and medium-sized radiolucent renal stones. These range from observation to oral dissolution therapy (ODT), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL).
Oral dissolving therapy diminishes the recurrence rates of stones. It positively influences the medical management of stone activity following ESWL in cases with residual calculi. By integrating oral dissolution therapy with extracorporeal shock wave lithotripsy, cases may experience the advantages of both non-invasive techniques. The combination of oral dissolution therapy and ESWL is an efficient therapeutic modality for radiolucent renal stones, dramatically reducing the overall stone volume. It also reduces the frequency of necessary extracorporeal shock wave lithotripsy sessions compared to treatment with ESWL alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral dissolution therapy group | Active comparator | Drug: Oral dissolution therapyPatients received guidance for oral potassium-sodium-hydrogen-citrate (6:6:3:5) at a dosage of twenty milliequivalents three times every day, along with a daily fluid intake of two to three liters and a food plan to restrict protein and sodium consumption for a maximum of three months. |
| Extracorporeal shock wave lithotripsy group | Experimental | Procedure: Extracorporeal shock wave lithotripsyPatients received extracorporeal shock wave lithotripsy utilizing a Dornier lithotripter equipped with an integrated ultrasound for stone localization. If the patient required additional sessions, up to a maximum of four sessions, at a rate of 60-90 shocks per minute, the period between sessions was three weeks. |
| Oral dissolution therapy + extracorporeal shock wave lithotripsy group | Experimental | Procedure: Oral dissolution therapy + extracorporeal shock wave lithotripsyPatients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Patients with a single radiolucent renal stone 0.5-2 cm at largest diameter diagnosed by non-contrast MSCT of the urinary tract (CTUT) ≤ 500 HU (Hounsfield Unit) and not seen on kidney, ureter, and bladder (KUB) X-ray.
Key exclusion criteria (3 listed)
- Patients with Coagulation disorders, a pacemaker, severe deformity of the skeletal system, anatomical obstruction distal to the stone, and obesity (Body Mass Index more than or equal to 35 kilograms per meter square).
- Patients with renal insufficiency (creatinine more than 1.7 mg/dl).
- Patients with active urinary tract infections.
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 |
|---|---|---|
| Oral dissolution therapyPatients received guidance for oral potassium-sodium-hydrogen-citrate (6:6:3:5) at a dosage of twenty milliequivalents three times every day, along with a daily fluid intake of two to three liters and a food plan to restrict protein and sodium consumption for a maximum of three months. | Drug | Oral dissolution therapy group |
| Extracorporeal shock wave lithotripsyPatients received extracorporeal shock wave lithotripsy utilizing a Dornier lithotripter equipped with an integrated ultrasound for stone localization. If the patient required additional sessions, up to a maximum of four sessions, at a rate of 60-90 shocks per minute, the period between sessions was three weeks. | Procedure or surgery | Extracorporeal shock wave lithotripsy group |
| Oral dissolution therapy + extracorporeal shock wave lithotripsyPatients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy. | Procedure or surgery | Oral dissolution therapy + extracorporeal shock wave lithotripsy group |
Primary outcome
Stone-free status
Time frame: 3 months after the procedure
To assess the stone-free status, which is characterized by no evidence of any residual stones in renal units by MSCT of the urinary tract (CTUT) at 3 months following oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), or combined ODT and ESWL.
1 secondary outcome
Complication rate
Time frame: 3 months after the procedure
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 7 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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 Oral dissolution therapy, Extracorporeal shock wave lithotripsy and Oral dissolution therapy + extracorporeal shock wave lithotripsy in people with Oral Dissolution Therapy and Extracorporeal Shock Wave Lithotripsy, run by Cairo 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 3 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 7 Feb 2025. 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 status (time frame: 3 months after the procedure). 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 7 Feb 2025.