Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University
About this trial
Calculous anuria caused by obstructing upper ureteral stones in a solitary functioning kidney is a urological emergency requiring urgent decompression. Both retrograde JJ ureteral stenting and percutaneous nephrostomy are commonly used emergency drainage methods. However, limited evidence is available regarding whether the initial drainage method affects subsequent definitive flexible ureteroscopy/retrograde intrarenal surgery outcomes.
This multicenter prospective randomized controlled trial will compare emergency JJ ureteral stent drainage versus percutaneous nephrostomy drainage in adult patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery. The study will assess renal functional recovery, first-session surgical success, stone-free rate, operative parameters, complications, and microbiological outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Calculous anuria secondary to a single upper ureteral stone.
Solitary functioning kidney, whether anatomical or functional.
Single upper ureteral stone confirmed by non-contrast computed tomography.
Disqualifiers
Multiple stones or bilateral stones not fitting the solitary-kidney study design.
Renal pelvic, distal ureteral, or multiple ipsilateral stones.
Stone burden greater than 20 mm.
Septic shock, hemodynamic instability, or need for emergency dialysis at presentation.
Trial design
Design model
Parallel
Treatments tested in this trial
Initial JJ Ureteral Stent Drainage
Procedure/SurgeryRetrograde cystoscopic placement of a 6 Fr JJ ureteral stent for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
Initial Percutaneous Nephrostomy Drainage
Procedure/SurgeryUltrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: JJ Ureteral Stent Drainage GroupActive comparator 1 intervention
Group B: Percutaneous Nephrostomy Drainage GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS
Serum creatinine will be measured in mg/dL at 24-48 hours after initial drainage and on postoperative day 1 after definitive tratment of stone by retrograde intrarenal surgery. The primary outcome will compare the change in serum creatinine from the post-drainage value to the post-RIRS value between the JJ ureteral stent drainage group.
Time frame
From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRSSecondary outcomes
1
First-Session Definitive RIRS Success Rate
First-session definitive RIRS success will be defined as successful completion of flexible ureteroscopy/retrograde intrarenal surgery for the target upper ureteral stone in the planned first definitive session without the need to abort the procedure or schedule an additional unplanned definitive stone procedure during the same treatment pathway. The proportion of participants achieving first-session success will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
Time frame
During the definitive RIRS procedure2
Stone-Free Rate After Definitive RIRS
Stone-free rate will be defined as the proportion of participants with no detectable residual target stone fragment on follow-up non-contrast computed tomography performed 4 weeks after definitive flexible ureteroscopy/retrograde intrarenal surgery. Stone-free rate will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group
Time frame
4 weeks after definitive RIRS3
During the definitive RIRS procedure
Total operative time will be measured in minutes from insertion of the cystoscope or ureteroscope to completion of the definitive flexible ureteroscopy/retrograde intrarenal surgery procedure. Mean or median operative time will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
Time frame
During the definitive RIRS procedure4
Need for Ureteral Stenting After Definitive RIRS
The need for postoperative ureteral stent placement after definitive flexible ureteroscopy/retrograde intrarenal surgery will be recorded. The proportion of participants requiring postoperative stenting will be compared between both drainage groups
Time frame
At the end of the definitive RIRS procedureOther outcomes
1
Ureteral Access Sheath Insertion Success Rate
Ureteral access sheath insertion success will be defined as successful placement of a ureteral access sheath during definitive flexible ureteroscopy/retrograde intrarenal surgery without the need for active ureteral dilatation, semirigid ureteroscopy assistance, or abandonment of sheath placement. The proportion of successful ureteral access sheath insertion will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
Time frame
During the definitive RIRS procedureSponsors and contacts
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Source ClinicalTrials.gov