Management of Medium Sized Renal Stones
Comparison Between Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy and Shockwave Lithotripsy for Treatment of Medium-sized Renal Stones: a Randomized Study
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. These stones are large enough to potentially cause significant obstruction and symptoms, yet their size and location make selecting an optimal treatment modality crucial for achieving favorable outcomes with minimal complications. Historically, open surgery was the primary intervention for large or complex stones. However, the advent of minimally invasive techniques has revolutionized stone management, allowing for more effective and patient-friendly approaches. Among these, Super-mini percutaneous nephrolithotomy (SMP), flexible uretero-renoscopy (F-URS), and shock wave lithotripsy (SWL) have emerged as minimally invasive modalities for managing medium-sized renal stones. This study aims to evaluate the outcomes; safety, efficacy, and complications associated with SMP versus F-URS Versus SWL in the management of reanl stones 10-20 mm in diameter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
December 3, 2024
CompletedFirst Posted
Study publicly available on registry
December 6, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
December 18, 2024
December 1, 2024
2 years
December 3, 2024
December 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone free rate
1\. SFR (by MSCT KUB) a patient is considered stone-free if the remaining fragments are less than 3 mm in size after 3 months of the procedure
3 months
Study Arms (3)
Modified Tubeless Super-Mini Percutaneous Nephrolithotomy
ACTIVE COMPARATORFlexible Ureterorenoscopy
ACTIVE COMPARATORShockwave Lithotripsy
ACTIVE COMPARATORInterventions
Modified Tubeless Super-Mini Percutaneous Nephrolithotomy
Eligibility Criteria
You may qualify if:
- Adult patients (≥ 18 years old)
- Single renal stones 10-20 mm in longest dimension
You may not qualify if:
- Previous upper urinary tract exploration in ipsilateral side.
- Patients with JJ stent in ipsilateral side.
- Absolute contraindications to SWL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Urologist
Study Record Dates
First Submitted
December 3, 2024
First Posted
December 6, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
December 18, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share