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

NCT ID: NCT06814834

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-12-20

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral dissolution therapy group

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.

Group Type: ACTIVE_COMPARATOR

Oral dissolution therapy

Intervention Type: DRUG

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 lithotripsy group

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.

Group Type: EXPERIMENTAL

Extracorporeal shock wave lithotripsy

Intervention Type: PROCEDURE

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 lithotripsy group

Patients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy.

Group Type: EXPERIMENTAL

Oral dissolution therapy + extracorporeal shock wave lithotripsy

Intervention Type: PROCEDURE

Patients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy.

Interventions

Oral dissolution therapy

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.

Intervention Type: DRUG

Extracorporeal shock wave lithotripsy

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.

Intervention Type: PROCEDURE

Oral dissolution therapy + extracorporeal shock wave lithotripsy

Patients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Ateya

Lecturer of Urology, Faculty of Medicine, Cairo University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

MS-556-2023

Identifier Type: -

Identifier Source: org_study_id