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

NCT07711028 | Active Not Recruiting DMC

• 1 other identifier: RC 19-12-2025
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Conditions

Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  Four weeks

Study Arms (2)

Role of urine PH

NO INTERVENTION

Role of urine PH in shock wave lithotripsy outcomes in renal stone disease

OTHER

Procedure: Shock Wave Iithotripsy; Procedure: Extracorporeal shock wave lithotripsy

Interventions

Shock Wave Iithotripsy PROCEDURE

ESWL in renal stone disease

Role of urine PH in shock wave lithotripsy outcomes 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.

Role of urine PH in shock wave lithotripsy outcomes in renal stone disease

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Benha, 74111, Egypt

Location

MeSH Terms

Interventions

Lithotripsy

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: January 20, 2026
• Primary Completion: July 20, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

EG (1)