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NCT Number: NCT07711028

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

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospitals

Banhā, Benha, 74111, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shock Wave Iithotripsy

Procedure

ESWL in renal stone disease

Extracorporeal shock wave lithotripsy

Procedure

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.

Primary outcomes

  1. Stone free rate

    Time frame: Four weeks

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

EFFECT of PH on Outcomes of ESWL in Renal Stones

Acronym: PHESWL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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