Role of Urine PH in Shock Wave Lithotripsy Outcomes in Re... | NCT07711028

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

NCT07711028

Sponsor

Benha University

Status

Active, not recruiting

Last Update Posted

Jul 17, 2026Actual

Enrollment

146Estimated

Phase

Not Applicable

Conditions

Shockwave Therapy

Interventions

Shock Wave Iithotripsy
Extracorporeal shock wave lithotripsy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2026Actual

Primary Completion Date

Jul 20, 2026Estimated

Completion Date

Oct 31, 2026Estimated

First Submitted Date

Jul 14, 2026

First Submission Date that Met QC Criteria

Jul 14, 2026

First Posted Date

Jul 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2026

Last Update Posted Date

Jul 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Shock Wave Iithotripsy	Procedure	ESWL in renal stone disease	Role of urine PH in shock wave lithotripsy outcomes in renal stone disease

Measure	Description	Time Frame
Stone free rate		Four weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

single renal calculus measuring less than 2 cm in its maximum diameter were enrolled for primary treatment with extracorporeal SWL.

Exclusion Criteria:

receiving any pH-altering medications, had multiple renal stones, or had indwelling ureteral stents.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Benha University Hospitals		Banhā	Benha	74111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008096	Lithotripsy

Ancestor Terms

ID	Term
D013812	Therapeutics
D059708	Ultrasonic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided

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.