Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

Kidney Stone Clinical Trial

Official title:

One-Day External Ureteral Catheter Versus Double-J Internal Ureteral Stent After Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738304
• Other study ID #: Uro_Azhar_11_023
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Al-Azhar University
• Contact: Abul-fotouh Ahmed, MD
• Phone: 00201001066756
• Email: abulfotouhahmed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Retrograde Intrarenal Surgery
• Ureteral Stent

Intervention

Procedure:
• Retrograde intrarenal surgery with external ureteral catheter
The retrograde fURS sheathless technique will be used in all cases, including (a) cystourethroscopy with the introduction of a guidewire into the ipsilateral ureter up to the collecting system; (b) Semi-rigid ureteroscopy (using 9.5 Fr, Karl Storz, semi-rigid ureteroscope) for visualization of the ureter for any abnormalities, the introduction of the second guidewire and hydrophilic ureteral dilation; (c) introduction of the flexible ureteroscope (8.6 Fr, single-use digital flexible ureteroscope, OUT Medical Inc.) over the guidewire up to the kidney; (d) removal of the working guidewire after visualization of the stone; and (e) fragmentation of the stone using a holmium YAG laser device. All procedure steps will be performed under direct visualization and fluoroscopy guidance. At the end of the procedure, an external ureteral catheter will be placed for 24 hours.
• Retrograde intrarenal surgery with double J internal ureteral stent
The retrograde fURS sheathless technique will be used in all cases, including (a) cystourethroscopy with the introduction of a guidewire into the ipsilateral ureter up to the collecting system; (b) Semi-rigid ureteroscopy (using 9.5 Fr, Karl Storz, semi-rigid ureteroscope) for visualization of the ureter for any abnormalities, the introduction of the second guidewire and hydrophilic ureteral dilation; (c) introduction of the flexible ureteroscope (8.6 Fr, single-use digital flexible ureteroscope, OUT Medical Inc.) over the guidewire up to the kidney; (d) removal of the working guidewire after visualization of the stone; and (e) fragmentation of the stone using a holmium YAG laser device. All procedure steps will be performed under direct visualization and fluoroscopy guidance. At the end of the procedure, a double-J internal ureteric stent will be placed for 2 weeks.

Locations

Country	Name	City	State
Egypt	Urology Department, Al-Azhar University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	No stones or residual fragments >3 mm on postoperative imaging study	up to 1 month
Primary	Stent-related symptoms	Irritative lower urinary tract symptoms	from post operative day one till double J removal; an average of 2 weeks
Secondary	Postoperative renal pain	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).	up to 1 month
Secondary	Rehospitalization rate	the need for unscheduled hospital admission	From post RIRS home discharge up to one month
Secondary	Reintervention rate	the need for reoperation	up to 3 months