Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

Not Applicable

Recruiting

• Conditions: Kidney Stone; Ureteral Stent; Retrograde Intrarenal Surgery
• Interventions: Procedure: Retrograde intrarenal surgery with double J internal ureteral stent; Procedure: Retrograde intrarenal surgery with external ureteral catheter

• Registration Number: NCT05738304
• Lead Sponsor: Al-Azhar University

Brief Summary

Several studies evaluated the benefit of a short-term external ureteral catheter (UC) compared to double-J (DJ) ureteral stent after flexible ureteroscopy (URS); the results were controversial. These studies had combined analyses of ureteral and renal stones with a high risk of selection bias. Studies comparing external UC and DJ stent after flexible URS for isolated renal stones are lacking.

In the present study, the investigators will compare the outcomes of using a one-day external UC versus a DJ internal ureteral stent for ureteral drainage after retrograde flexible URS (retrograde intrarenal surgery "RIRS") for renal stones. The investigators aim to identify the best ureteral drainage method after RIRS regarding stone clearance, complications, and stent-related symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Study First Submitted: 2023-02-11
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-02-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Adult patients of either gender in whom RIRS was the primary modality.

Exclusion Criteria

• Pregnant women
• Active urinary tract infection
• solitary kidney
• Concomitant pathology that need intervention in the same setting
• Patients with surgical incidents that indicate double-J stenting (Residual sizable fragments, ureteral false passage, ureteral mucosal laceration, ureteral perforation, and calyceal rupture).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double J group	Retrograde intrarenal surgery with double J internal ureteral stent	After RIRS, a double J internal ureteral stent will be placed for 2 weeks.
External Ureteral Catheter group	Retrograde intrarenal surgery with external ureteral catheter	After RIRS, an external ureteral catheter will be placed for one day.

Primary Outcome Measures

Name	Time	Method
Stent-related symptoms	from post operative day one till double J removal; an average of 2 weeks	Irritative lower urinary tract symptoms
Stone free rate	up to 1 month	No stones or residual fragments \>3 mm on postoperative imaging study

Secondary Outcome Measures

Name	Time	Method
Reintervention rate	up to 3 months	the need for reoperation
Postoperative renal pain	up to 1 month	Renal pain attacks and severity as evaluated by visual analogue pain scale (VAPS).; The VAPS is a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Rehospitalization rate	From post RIRS home discharge up to one month	the need for unscheduled hospital admission

Trial Locations

Locations (1)

Urology Department, Al-Azhar University Hospital; 🇪🇬 Cairo, Egypt