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Role of Urine PH in Shock Wave Lithotripsy Outcomes in Renal Stone Disease

NCT07711028 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-07-20

No results posted yet for this study

Summary

urolethiasis (kidney stones) is common globally, with recurrence in 50% of patients.

* Shock Wave Lithotripsy (SWL) is a minimally invasive treatment for stones \< 2 cm.
* Hypothesis: Urine pH might influence SWL success and could be manipulated pre-procedure. Aim of the work is to evaluate the role urine pH on the outcomes of shock wave lithotripsy in renal stones. patients and methods The study will be conducted over 146 patients( with single renal stone \< 2 cm) in Urology department of Banha university Hopitals from Dec 2025 till Dec 2026. Exclusions: patients on pH altering drugs, multiple stones,stents. Procedure: SWL Siemens Lithoscope up to 3 sessions per patient. Data collected : Age, BMI, urine pH, specific gravity(SG), stone size, location, Hounsfield unit(HU), skin to stone distance (SSD). Analysis Chi-square\& t-test; significance at p\<0.05. Results Will be tabulated and statistically analyzed

Conditions

  • Shockwave Therapy

Interventions

PROCEDURE

Shock Wave Iithotripsy

ESWL in renal stone disease

PROCEDURE

Extracorporeal shock wave lithotripsy

The procedures utilized advanced lithotripsy systems, specifically the Siemens Lithoskop and a piezoelectric lithotripter (Piezolith 3000 Plus, Richard Wolf, Germany) equipped with direct-focusing shockwave technology and triple focus size localization capabilities (F1 =2 mm, F2 =4 mm, F3 =8 mm). During the procedure, an integrated ultrasound device was primarily used to locate and continuously monitor the targeted stone in real-time, significantly minimizing radiation exposure. Fluoroscopy was employed only briefly and strictly to confirm the anatomical position and radiolucency of lower calyceal stones. The procedural parameters were standardized across the cohort: the shockwave delivery rate was set at 90 pulses per minute, with a strict safety cap of 3000 shockwaves per session. The mechanical fragmentation strategy utilized a progressive focusing technique. Treatment commenced with the smallest focal size (F1) to safely initiate stone breakdown.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2026-07-20
Completion
2026-10-31

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 NCT07711028 on ClinicalTrials.gov