Shockwave TherapyPHESWLNCT07711028
Role of Urine PH in Shock Wave Lithotripsy Outcomes in Renal Stone Disease
A study testing Shock Wave Iithotripsy and Extracorporeal shock wave lithotripsy in people with Shockwave Therapy, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shockwave Therapy
- What is being tested?
- Shock Wave Iithotripsy and Extracorporeal shock wave lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single renal calculus.
- Stones less than 2 cm in its maximum diameter.
Who cannot join
- Patients receiving any pH-altering medications.
- Patients have multiple renal stones.
- Patients have indwelling ureteral stents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT of PH on Outcomes of ESWL in Renal Stones
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
- Being tested
- Shock Wave Iithotripsy, Extracorporeal shock wave lithotripsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Wave IithotripsyProcedure or surgery
ESWL in renal stone disease
Extracorporeal shock wave lithotripsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Role of urine PH | No intervention | Not described |
| Role of urine PH in shock wave lithotripsy outcomes in renal stone disease | Other | Not described Receives: Procedure: Shock Wave Iithotripsy; Procedure: Extracorporeal shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start20 Jan 2026
- Primary completion20 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shockwave TherapyStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abou Elezz Abdel Fattah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711028
- Sponsor's protocol ID
- RC 19-12-2025
- Acronym
- PHESWL
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT of PH on Outcomes of ESWL in Renal Stones
- ClinicalTrials.gov ID
- NCT07711028
- Acronym / sponsor ID
- PHESWL / RC 19-12-2025
- Conditions
- Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single renal calculus.
- Stones less than 2 cm in its maximum diameter.
Key exclusion criteria (3 listed)
- Patients receiving any pH-altering medications.
- Patients have multiple renal stones.
- Patients have indwelling ureteral stents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shock Wave IithotripsyESWL in renal stone disease | Procedure or surgery | Role of urine PH in shock wave lithotripsy outcomes in renal stone disease |
| Extracorporeal shock wave lithotripsyThe 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. | Procedure or surgery | Role of urine PH in shock wave lithotripsy outcomes in renal stone disease |
Primary outcome
Stone free rate
Time frame: Four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock Wave Iithotripsy and Extracorporeal shock wave lithotripsy in people with Shockwave Therapy, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.