- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07610252
Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) and Ultra-mini Percutaneous Nephrolithotomy (PCNI), in Renal Stones <20 mm.
May 20, 2026 updated by: Muhammad Aamir Latif
Comparison of the Outcome of Extracorporeal Shock Wave Lithotripsy (ESWL) and Ultra-mini Percutaneous Nephrolithotomy (PCNL), in Renal Stones <20 mm.
There is a dearth of information comparing ultra-mini PNCL with ESWI in Pakistan for kidney stones smaller than 20 mm.
Hence the current study was planned with the objective of comparing the outcome of ESWL and ultra-mini PCNL in renal stones less than 20 mm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Even though small PCNL and ESWL are tried-and-true techniques for kidney calculus, their usage poses unique challenges since they need precision to guarantee effective stone removal while minimizing invasiveness.
Despite these advantages, selecting the optimum course of action is challenging due to risks of both modalities.
The results of this investigation would therefore help to improve the treatment of the patients with renal proximal stones that are smaller than 20 mm.
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Bahawalpur, Punjab Province, Pakistan, 63100
- Bahawal Victoria Hospital/Quaid-e-Azam Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients of any gender
- Aged 20-60 years
- With a single kidney stone in renal pelvis smaller than 20 mm
Exclusion Criteria:
- Pregnancy
- Hemorrhage problems
- Sepsis and pyonephrosis
- With pelvic kidneys
- Obstruction of the pelvi-ureteric junction
- Chronic illness (chronic liver disease, chronic renal failure, chronic drug use)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group-A
Patients were treated with ultra-mini PCNL with double J stent implantation.
|
Patients were treated with ultra-mini PCNL with DJ stent implantation.
|
|
Experimental: Group-B
Extracorporeal shock wave lithotripsy (ESWL) with double J stent implantation was performed in patients.
Typically, the therapy began with a lower power of 1 kilovolt (kV) and was progressively increased to 20 kV.
Each session included no more than 2000 shocks.
|
Extracorporeal shock wave lithotripsy (ESWL) with DJ stent implantation was performed in patients.
Typically, the therapy began with a lower power of 1 kV and was progressively increased to 20 kV.
Each session included no more than 2000 shocks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stone clearance
Time Frame: 4 weeks
|
The frequency of the patients with full stone clearance was noted and cmpared between the groups.
|
4 weeks
|
|
Urinary tract infection
Time Frame: 4 weeks
|
The frequency of patients reported with urinary tract infection was noted and compared between the groups.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Saleem, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
- Study Director: Mumtaz Rasool, FCPS, Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
May 20, 2026
First Submitted That Met QC Criteria
May 20, 2026
First Posted (Actual)
May 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Therapeutics
- Surgical Procedures, Operative
- Ultrasonic Surgical Procedures
- Lithotripsy
Other Study ID Numbers
- Dr-Saleem-BVH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data can be shared on a reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Calculi
-
Amai Charitable TrustUnknown
-
Changhai HospitalThe First Affiliated Hospital of Anhui Medical University; The First Affiliated... and other collaboratorsUnknown
-
Institute for the Study of Urological Diseases,...CompletedRenal Insufficiency | Renal CalculiGreece
-
Hadassah Medical OrganizationGrumentalCompletedRenal CalculusIsrael
-
Al-Azhar UniversityRecruiting
-
Kırıkkale UniversityCompletedKidney Calculi Nephrolithiasis Urolithiasis Renal Stone
-
Ain Shams UniversityCompleted
-
Mansoura UniversityCompleted
-
Seoul National University HospitalSMG-SNU Boramae Medical CenterCompleted
-
Seoul National University HospitalSK Telecom ConsortiumCompleted
Clinical Trials on Ultra-mini PCNL
-
The First Affiliated Hospital of Guangzhou Medical...Not yet recruiting
-
Mahidol UniversityNot yet recruitingSafety Issues | Surgery-Complications | Nephrolithiasis Staghorn CalculusThailand
-
Ain Shams UniversityCompleted
-
The First Affiliated Hospital of Guangzhou Medical...Massachusetts General Hospital; University College London Hospitals; University... and other collaboratorsUnknownSurgery | Stone, Kidney | Lithiasis Renal
-
Hayat Abad Medical Complex, Peshawar.CompletedRenal Stones | Urolithiasis, Calcium OxalatePakistan
-
Auris Health, Inc.Completed
-
The First Affiliated Hospital of Guangzhou Medical...The First Affiliated Hospital with Nanjing Medical University; University of... and other collaboratorsCompleted
-
Ain Shams UniversityCompleted
-
Yasser Gamil ElnagarCompletedKidney Stone | Calculi, RenalEgypt
-
Auris Health, Inc.CompletedKidney CalculiUnited States