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

EFFECT of PH on Outcomes of ESWL in Renal Stones

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07711028
Acronym
PHESWL
Enrollment
146
Registered
2026-07-17
Start date
2026-01-20
Completion date
2026-10-31
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shockwave Therapy

Brief 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

Interventions

PROCEDUREShock Wave Iithotripsy

ESWL in renal stone disease

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

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Shock Wave Lithotripsy Protocol All SWL interventions were performed as outpatient procedures. Patients underwent a maximum of three treatment sessions. 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Single renal calculus. * Stones less than 2 cm in its maximum diameter.

Exclusion criteria

* Patients receiving any pH-altering medications. * Patients have multiple renal stones. * Patients have indwelling ureteral stents.

Design outcomes

Primary

MeasureTime frame
Stone free rateFour weeks

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026