Flexible vs Semi-rigid URS

Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy in Upper Third Ureteric Stones Management: a Prospective Randomized Trial

To compare the efficacy, safety, success rate, operative time, and cost-effectiveness of flexible ureteroscopy versus semirigid ureteroscopy in the management of upper ureteric stones smaller than 2 cm.

The investigators' main concern in this study is Upper third ureteric stones to determine which cases can be treated with Semi-Rigid Ureteroscopy, and which one needs flexible ureteroscopy. This depends on several factors:

1. Division of the upper third of the ureter
2. Stone size
3. Stone impaction
4. Surgeon experience
5. Anesthesia
6. Ureteric dilatation above the stone
7. Mini endoscopy

Study Overview

• Status: Recruiting
• Conditions: Ureteric Stone; Upper Urinary Tract Stones; Flexible Ureteroscopy
• Intervention / Treatment: Procedure: Flexible URS; Procedure: Semi-Rigid URS

Detailed Description

Ureteroscopy (URS) is a widely accepted minimally invasive approach for treating ureteric stones, particularly proximal (upper) ureteral stones. Options include rigid, semirigid (often grouped as one), and flexible ureteroscopes. Flexible ureteroscopy allows deflection and access to the proximal ureter and intrarenal collecting system, facilitating treatment of stones that are difficult to reach with rigid ureteroscopes due to anatomical constraints or stone migration. Semirigid ureteroscopy has shown good efficacy, particularly for stones amenable to direct access without complex deflection, offering shorter operative times and lower costs. Studies report stone-free rates of approximately 90-93% for flexible URS and 81-90% for semirigid URS, with flexible URS having somewhat higher success in accessing stones and managing fragment migration. However, flexible URS typically incurs higher costs and longer operative times. Semirigid ureteroscopy is often the initial approach for upper ureteric stones where anatomy, stone size (<2 cm), and location allow straightforward access.

• Flexible ureteroscopy is preferred when stones are located higher in the ureter, difficult to reach by semirigid scopes, or if stone migration into the kidney occurs. It is also favored when more maneuverability is required to treat complex anatomy or large stones.
• Both modalities use holmium laser lithotripsy for stone fragmentation.
• Treatment choice also depends on surgeon preference, availability of equipment, and cost considerations.

Despite advances, there is ongoing debate about the optimal first-line ureteroscopic approach for upper ureteric stones, balancing efficacy, safety, cost, and procedure time. Comparing flexible and rigid/semirigid ureteroscopy outcomes informs treatment algorithms, improving patient care and resource utilization, especially in differing healthcare settings.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar Ahmed Hamada Ali; Phone Number: +201092868286; Email: omarahmedhamada74@gmail.com
• Study Contact Backup: Name: Mohamed Ragab Abdallah, Doctor; Phone Number: +201066237580; Email: mohammedurology1290@gmail.com

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt
      • Recruiting
      • Assiut Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ≥18 years
• upper ureteric stone
• ≤20 mm

Exclusion Criteria:

• Associated renal stones
• Any contraindications to Anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flexible Ureteroscopy	Procedure: Flexible URS; Flexible URS
Experimental: Semi-Rigid Ureteroscopy	Procedure: Semi-Rigid URS; Semi-Rigid URS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- Stone-free rate at 3 months duration	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Granholm L, Svendgaard N. Hydrocephalus following traumatic head injuries. Scand J Rehabil Med. 1972;4(1):31-4. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Ureteral Diseases; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Urinary Calculi
• Other Study ID Numbers: Upper third ureteric stones

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No