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

NCT06814834 | Completed

• 1 other identifier: MS-556-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after the procedure

Secondary Outcomes (1)

• Complication rate

  3 months after the procedure

Study Arms (3)

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.

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.

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.

Procedure: Oral dissolution therapy + extracorporeal shock wave lithotripsy

Interventions

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.

Oral dissolution therapy group

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.

Extracorporeal shock wave lithotripsy group

Oral dissolution therapy + extracorporeal shock wave lithotripsy PROCEDURE

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

Oral dissolution therapy + extracorporeal shock wave lithotripsy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 7, 2025
• Study Start: December 20, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)