Treatment of Upper Ureteric Stones

Ureteric Stones Clinical Trial

Official title:

A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02469766
• Other study ID #: upper ureteric stones
• Status: Recruiting
• Phase: Phase 4
• First received: June 9, 2015
• Last updated: August 28, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Mansoura University
• Contact: Muhamad M abdallateef, MD
• Phone: 01009681644
• Email: seif_1901[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

Description:

This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

• Radio-opaque stones

• less than or equal 1 cm

Exclusion Criteria:

• Active UTI

• Coagulopathy

• Pregnancy

• Ureteric stricture

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Ureteral Calculi
• Ureteric Stones
• Ureterolithiasis

Intervention

Procedure:
• SWL
Patients in this arm will undergo SWL
• Semirigid URS
Patients in this arm will undergo semirigid URS
• Flexible URS
Patients in this arm will undergo Flexible URS

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Dakhlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	The stone free rate will be evaluated with non-contrast CT	3 months	No
Secondary	Complication rate	Complications will be classified according to modified Clavien Dindo	2 weeks	Yes