NCT07610252

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stone clearance

    The frequency of the patients with full stone clearance was noted and cmpared between the groups.

    4 weeks

  • Urinary tract infection

    The frequency of patients reported with urinary tract infection was noted and compared between the groups.

    4 weeks

Study Arms (2)

Group-A

EXPERIMENTAL

Patients were treated with ultra-mini PCNL with double J stent implantation.

Procedure: Ultra-mini PCNL

Group-B

EXPERIMENTAL

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.

Procedure: Extracorporeal shock wave lithotripsy

Interventions

Patients were treated with ultra-mini PCNL with DJ stent implantation.

Group-A

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.

Group-B

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of any gender
  • Aged 20-60 years
  • With a single kidney stone in renal pelvis smaller than 20 mm

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahawal Victoria Hospital/Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Muhammad Saleem

    Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

    PRINCIPAL INVESTIGATOR
  • Mumtaz Rasool, FCPS

    Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations