Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease

Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease , Two vs Four Weeks Prospective Study

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished : fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

Study Overview

• Status: Completed
• Conditions: Ureteric Stone
• Intervention / Treatment: Procedure: Renal stent; Device: Flexible uretroscopy

Detailed Description

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • State Or Province
    • Cairo, State Or Province, Egypt, 32511
      • Menofia University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• All patients with stone kidney up to 2 cm
• failed ESWL (extracorporeal shock wave lithotripsy)
• difficult PCNL (percutaneous nephrolithotomy)

Exclusion Criteria:

• Size more than 2 cm

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: 2 weeks Dj insertion; Renal stent for 2 weeks prior flexible uretroscopy	Procedure: Renal stent; Renal stent before flexible uretroscopy; Device: Flexible uretroscopy; Renal stent for 2 weeks prior flexible uretroscopy
Active Comparator: 4weeks Dj insertion; Renal stent for 4 weeks prior flexible uretroscopy	Procedure: Renal stent; Renal stent before flexible uretroscopy; Device: Flexible uretroscopy; Renal stent for 2 weeks prior flexible uretroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks	Patients will classified in two groups, one will insert DJ for two weeks and the other insert DJ for four weeks then remove it and trial to insert access sheath for flexible uretroscopy duriing passage of the sheath the ureteric dilitation will be assessed if the sheath pass or not measure so , the ability of the ureteric dilitation to obtain the sheath is it dilated enough after 2 or 4 weeks	6 months

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

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; Urinary Calculi; Ureteral Diseases; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: 5/2024UROL2

Drug and device information, study documents

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