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

Cairo University (CU)

Status: Completed

Conditions: Noninvasive; Radiolucent Renal Stones; Extracorporeal Shock Wave Lithotripsy; Medium; Small; Oral Dissolution Therapy

Treatments: Procedure: Oral dissolution therapy + extracorporeal shock wave lithotripsy; Drug: Oral dissolution therapy; Procedure: Extracorporeal shock wave lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06814834

MS-556-2023

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Oral dissolution therapy group

Active Comparator group

Description:

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.

Treatment:

Drug: Oral dissolution therapy

Extracorporeal shock wave lithotripsy group

Experimental group

Description:

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.

Treatment:

Procedure: Extracorporeal shock wave lithotripsy

Oral dissolution therapy + extracorporeal shock wave lithotripsy group

Experimental group

Description:

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

Treatment:

Procedure: Oral dissolution therapy + extracorporeal shock wave lithotripsy