Flexible vs Semi-rigid URS

NCT ID: NCT07247617

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-01-01

Brief Summary

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

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.

Conditions

Ureteric Stone; Flexible Ureteroscopy; Upper Urinary Tract Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flexible Ureteroscopy

Group Type: ACTIVE_COMPARATOR

Flexible URS

Intervention Type: PROCEDURE

Flexible URS

Semi-Rigid Ureteroscopy

Group Type: EXPERIMENTAL

Semi-Rigid URS

Intervention Type: PROCEDURE

Semi-Rigid URS

Interventions

Flexible URS

Flexible URS

Intervention Type: PROCEDURE

Semi-Rigid URS

Semi-Rigid URS

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Associated renal stones
• Any contraindications to Anesthesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Ahmed Hamada Ali

Urology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut Hospital

Asyut, Asyut Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omar Ahmed Hamada Ali

Role: CONTACT

omarahmedhamada74@gmail.com

+201092868286

Mohamed Ragab Abdallah, Doctor

Role: CONTACT

mohammedurology1290@gmail.com

+201066237580

References

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

Reference Type: RESULT

PMID: 4220357 (View on PubMed)

Other Identifiers

Upper third ureteric stones

Identifier Type: -

Identifier Source: org_study_id