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The Ideal Time Interval Between Repeated Shock Wave Lithotripsy Sessions For Renal Stones: A Randomized Controlled Trial

NCT04575480 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-10-05

No results posted yet for this study

Summary

There is no consensus about the required time intervals between repeated SWL sessions applied for renal stones with some centers waiting for 3 days, others for one week and others up to one month to repeat lithotripsy. In the 2019 EUA guidelines stated that "There are no conclusive data on the intervals required between repeated SWL sessions. However, clinical experience indicates that repeat sessions are feasible (within 1 day for ureteral stones).

The intense use of ESWL currently, the lack of knowledge about acute lesions caused by re-treatment within a short time interval and the empirical way by which treatment is conducted, stimulated us to search for a precise answers to the question What the ideal time interval between SWL sessions in the treatment of renal stone patients should be.

This randomized controlled trial will be conducted at Urology and Nephrology Center in Mansoura, Egypt. Patients more than 18 years old with single primary renal stone fulfilling inclusion criteria will be randomly allocated to 3 groups (50 patients each).Group 1 will undergo SWL with 3 days between each session. Group 2 will undergo SWL with 7 days between each session and Group 3 will undergo SWL with 14 days between each session.

Study parameters will be renal damage including the following items:

* Tubular damage will be assessed through estimation of changes in urinary excretion of renal tubular enzyme kidney injury molecule 1(KIM-1).
* Glomerular damage will be assessed by estimation of proteinuria and changes in GFR calculated by renal isotope scan.
* Renal morphological and haemodynamic changes.
* Treatment success is defined as clinically insignificant residual fragments less than 4 mm size.

Conditions

  • Ideal Time Interval

Interventions

PROCEDURE

Shock Wave Lithotripsy for renal stone.

The following protocol will be applied for all patients in study groups. SWL will be performed using the Dornier Gemini lithotripter (Dornier MedTech, Wessling, Germany) . A total of 3 000 shocks will be delivered at 80 shocks/min. The patient will receive 1 mg/kg pethidine i.v. for analgesia. Treatment will begin at machine power step 1, which will deliver 49 MPa focal pressure and 0.35 mJ/mm2. Power will be gradually increased by one step for each 200 shocks up to step 4, which deliver 70 MPa and 0.7 mJ/mm2. The maximum session number will be 3 session. Patient treated with \<2 sessions will be excluded from the analysis

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2022-07-15
Completion
2023-01-01
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575480 on ClinicalTrials.gov