Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi

NCT04759599 | Unknown DMC

• 1 other identifier: MD 1-11-2020
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the narrow focus (F1) versus the wide focus (F3) in terms of the efficacy of Shock Wave Lithotripsy (SWL) in the management of renal calculi 1-2 cm and their injurious effect on the kidney.

Conditions

Renal Stone; Treatment Side Effects

Outcome Measures

Primary Outcomes (1)

• Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free

  Assessment of efficacy of Shock Wave Lithotripsy (SWL) and its success by calculation of stone free (%) following each session with a maximum of 3 Shock Wave Lithotripsy (SWL) sessions, 2 weeks a part, using pelvi-abdominal Ultrasound (US) and Kidney-Ureter-Bladder (KUB) and the presence of significant residual stone \>4 mm will be considered "non-stone free" and the final stone free status (%) will be calculated at one month following the last session of Shock Wave Lithotripsy (SWL). Shock Wave Lithotripsy (SWL) failure will be defined as failure to reach stone free status (%) one month after 3rd session.

  1 year

Secondary Outcomes (4)

• Assessment of the degree of renal injury using renal injury markers

  1 year

• Assessment of the presence of peri-renal hematoma

  1 year

• Assessment of the changes in renal cortical thickness

  1 year

• Measurement of the changes in the Renal Resistive Index (RRI)

  1 year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1 will undergo Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks

Procedure: Shock Wave Lithotripsy (SWL)

Group 2

ACTIVE COMPARATOR

Group 2 will undergo Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks

Procedure: Shock Wave Lithotripsy (SWL)

Interventions

Shock Wave Lithotripsy (SWL) PROCEDURE

Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks or Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18years old) with 1-2 cm single renal stone.
• Normal functioning kidney.

You may not qualify if:

• Pregnancy.
• Bleeding diatheses.
• Radiolucent stones.
• Radio-opaque stones with Hounsfield Unit (HU) \> 1200
• Patients with a pacemaker.
• Active Urinary Tract Infection (UTI).
• Severe skeletal malformations.
• Morbid obesity with Body Mass Index (BMI) ≥40 kg/m2.
• Renal artery aneurysm at the same site of the stone.
• Anatomical obstruction distal to the stone.
• Patients with renal impairment with serum creatinine \> 1.2 mg/dL.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Faculty of Medicine, Benha University

Banhā, Kalyobiya, 13518, Egypt

RECRUITING

Related Publications (4)

• Turney BW, Reynard JM, Noble JG, Keoghane SR. Trends in urological stone disease. BJU Int. 2012 Apr;109(7):1082-7. doi: 10.1111/j.1464-410X.2011.10495.x. Epub 2011 Aug 26.

  PMID: 21883851 BACKGROUND

• Connors BA, Evan AP, Blomgren PM, Handa RK, Willis LR, Gao S. Effect of initial shock wave voltage on shock wave lithotripsy-induced lesion size during step-wise voltage ramping. BJU Int. 2009 Jan;103(1):104-7. doi: 10.1111/j.1464-410X.2008.07922.x. Epub 2008 Aug 1.

  PMID: 18680494 BACKGROUND

• Devarajan P. Biomarkers for the early detection of acute kidney injury. Curr Opin Pediatr. 2011 Apr;23(2):194-200. doi: 10.1097/MOP.0b013e328343f4dd.

  PMID: 21252674 BACKGROUND

• Veser J, Jahrreiss V, Seitz C, Ozsoy M. The effect of focus size and intensity on stone fragmentation in SWL on a piezoelectric lithotripter. World J Urol. 2020 Oct;38(10):2645-2650. doi: 10.1007/s00345-019-03069-y. Epub 2020 Jan 10.

  PMID: 31925550 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Yasser Noureldin, MD, PhD

  Benha University

  PRINCIPAL INVESTIGATOR

• Ahmed Abdelbaky, MD, PhD

  Benha University

  STUDY CHAIR

• Walid Ibrahim, MD, PhD

  Benha University

  STUDY DIRECTOR

• Ezzat Elnahife, MD

  Benha University

  STUDY DIRECTOR

• Salah El Hamshary, MD, PhD

  Benha University

  STUDY DIRECTOR

Central Study Contacts

Yasser Noureldin, MD, PhD

CONTACT

01225352115; dryasser.noor@fmed.bu.edu.eg

Ezzat Elnahife, MD

CONTACT

01008117250; ezatsaid14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 18, 2021
• Study Start: February 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

EG (1)