Health Trials

Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

ConditionsKidney StoneRetrograde Intrarenal SurgeryUreteral Stent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pregnant women

Active urinary tract infection

solitary kidney

Concomitant pathology that need intervention in the same setting

Trial design

Design model

Parallel

Treatments tested in this trial

  • Retrograde intrarenal surgery with external ureteral catheter

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: External Ureteral Catheter groupExperimental treatment 1 intervention
Group B: Double J groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone free rate

No stones or residual fragments \>3 mm on postoperative imaging study

Time frame
up to 1 month
2

Stent-related symptoms

Irritative lower urinary tract symptoms

Time frame
from post operative day one till double J removal; an average of 2 weeks

Secondary outcomes

1

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).

Time frame
up to 1 month
2

Rehospitalization rate

the need for unscheduled hospital admission

Time frame
From post RIRS home discharge up to one month
3

Reintervention rate

the need for reoperation

Time frame
up to 3 months

Other outcomes

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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