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Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05896345
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
43
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.

Condition or Disease Intervention/Treatment Phase
  • Device: SWL
  • Combination Product: SWL and ODT
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone. A Randomised Controlled Trial
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SWL

Shockwave Lithotripsy (SWL)

Device: SWL
Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone
Active Comparator: SWL and ODT

Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)

Combination Product: SWL and ODT
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

Outcome Measures

Primary Outcome Measures

  1. Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm [3 month]

    percentage of patient who are stone free

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 1-2.5 cm renal stone

  • Normal Serum creatinine

  • Radiolucent stone with Hounsfield units less than 400

Exclusion Criteria:

  • Bleeding diatheses.

  • Patients with a pacemaker.

  • uncontrolled UTIs.

  • Severe skeletal malformations.

  • Arterial aneurysm in the vicinity of the stone.

  • Anatomical obstruction distal to the stone.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology and Nephrology Center Mansoura Outside U.S./Canada Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05896345
Other Study ID Numbers:
  • Paediatrics RLS
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases

Study Results

No Results Posted as of Jun 9, 2023