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NCT Number: NCT06814834

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Cairo Governorate, 12613, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral dissolution therapy

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

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

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complication rate

    Time frame: 3 months after the procedure

    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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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