Mini-PNL, RIRS, and ESWL for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones

NCT04856722 | Completed

• 1 other identifier: Uro_Azhar_11_021
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal management of medium-sized renal stones remains quite challenging and continues to be contested. In the present study, the investigators will compare mini-PNL, RIRS and SWL in the treatment of non- lower pole, medium size, high dense renal stones regarding the stone-free rate, the safety of the procedures, cost, and patients' and surgeon's satisfaction. Eligible patients will be randomly allocated into three equal groups (mini-PNL, RIRS, and SWL). Postoperative, patients will be followed-up by regularly for 3 months. The study parameters will be compared between groups.

Conditions

Renal Stone; Percutaneous Nephrolithotomy; Retrograde Intrarenal Surgery; Extracorporeal Shockwave Lithotripsy

Outcome Measures

Primary Outcomes (2)

• Stone-free rate

  Stone free status is defined as no residual renal stone or residual fragment(s) less than 4 mm size.

  as detected by non-contrasted computed tomography 3 months after the intervention procedures.

• Complication rate

  intra- and post-operative complications

  up to 3 months.

Secondary Outcomes (3)

• Cost of treatment

  throughout the study procedure, up to 3 months post-operative.

• Patients satisfaction

  throughout the study procedure, up to 3 months post-operative

• Surgeon's satisfaction.

  throughout the study procedure, up to 3 months post-operative

Study Arms (3)

mini-PNL group

EXPERIMENTAL

In which PCNL will be performed using miniature nephroscope

Procedure: mini-PNL

RIRS group

EXPERIMENTAL

In which RIRS will be performed using a flexible ureteroscope

Procedure: RIRS

SWL group

EXPERIMENTAL

In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII

Procedure: SWL

Interventions

mini-PNL PROCEDURE

PCNL using miniature nephroscope. The procedure will be performed under general or regional anaesthesia under fluoroscopy guidance.

mini-PNL group

RIRS PROCEDURE

RIRS using flexible ureteroscope. The procedure will be performed under general or regional anaesthesia under fluoroscopy guidance. Holmium Laser lithotripter will be used for stone fragmentation.

RIRS group

SWL PROCEDURE

SWL using Dornier SII lithotripter. the procedure will be performed under sedoanalgesia, and fluoroscopy will be used for stone localization; for a maximum of 3 SWL session.

SWL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (both genders)
• Single non-lower pole renal stone.
• Stone size: 10-20 mm.
• Stone density: \> 1000 HU.

You may not qualify if:

• Pregnant women.
• Morbid obesity.
• Severe orthopaedic deformities.
• Co-morbidities precluding general anaesthesia or prone positioning.
• Uncorrectable coagulation disorders.
• Active urinary tract infection (UTI).
• Stone in a calyceal diverticulum.
• Abnormal renal anatomy.
• Urinary tract obstruction distal to the stone.
• Concomitant pathology that needs intervention in the same setting.
• Advanced hydronephrosis.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Urology Department, Al-Azhar University Hospital

Cairo, 11633, Egypt

Location

Related Publications (1)

• Ahmed AF, Raafat M, ElDamanhory H, Abdelazim H, Soliman A, ElShazly A, Hindawy M, Anwar M, Algammal M, Soliman A, Daoud A. Prospective randomized trial comparing mini-percutaneous nephrolithotomy, retrograde intrarenal surgery, and shock wave lithotripsy for treatment of medium-sized high-density renal stones. Int Urol Nephrol. 2025 Dec 12. doi: 10.1007/s11255-025-04928-x. Online ahead of print.

  PMID: 41385038 DERIVED

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Abul-fotouh Ahmed, MD

  Al-Azhar University Hospitals, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

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: Professor of Urology and Andrology

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 23, 2021
• Study Start: April 5, 2021
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: December 12, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)