Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Stone, Retrograde Intrarenal Surgery, Ureteral Stent

Intervention / Treatment
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* Procedure: Retrograde intrarenal surgery with external ureteral catheter
* Procedure: Retrograde intrarenal surgery with double J internal ureteral stent


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: External Ureteral Catheter group<br>After RIRS, an external ureteral catheter will be placed for one day. | Procedure: Retrograde intrarenal surgery with external ureteral catheter<br>* 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.<br>|
| Active Comparator: Double J group<br>After RIRS, a double J internal ureteral stent will be placed for 2 weeks. | Procedure: Retrograde intrarenal surgery with double J internal ureteral stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Rehospitalization rate | the need for unscheduled hospital admission | From post RIRS home discharge up to one month | 
| Reintervention rate | the need for reoperation | up to 3 months |