Calculous AnuriaNCT07627880
Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria
A study testing Initial JJ Ureteral Stent Drainage and Initial Percutaneous Nephrostomy Drainage in people with Calculous Anuria and Upper Ureteral Stone, run by Beni-Suef University at 3 sites in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calculous Anuria, Upper Ureteral Stone, Obstructive Uropathy
- What is being tested?
- Initial JJ Ureteral Stent Drainage and Initial Percutaneous Nephrostomy Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesEgypt
- Study dates
- 6 May 2026to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Stone size from 6 mm to 20 mm in maximum diameter.
- Patient considered suitable for either initial JJ ureteral stent drainage or percutaneous nephrostomy drainage.
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- Candidate for definitive treatment by flexible ureteroscopy/retrograde intrarenal surgery.
- Documented renal functional improvement and clinical stabilization before definitive RIRS.
- Negative or appropriately treated urine culture before definitive RIRS.
- Ability and willingness to provide written informed consent.
Who cannot join
- 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.
- Pyonephrosis requiring a non-randomized drainage decision.
- Anatomical abnormalities affecting endoscopic access, such as horseshoe kidney, pelvic kidney, ureterocele, or ureteral stricture.
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- Previous ipsilateral ureteral reconstructive surgery.
- Uncorrected coagulopathy.
- Pregnancy.
- Genitourinary malignancy.
- Inability to complete follow-up.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites, 3 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate
Hany F Badawy, MD, +201149525028, Hanyfathy86@gmail.com
Hany F Badawy, MD
- Recruiting
Department of Urology- Minia University Hospitals
Minya, Minya Governorate
M Abdelmalek, MD, +20 11 00464753
M Abdelmalek, MD
- Recruiting
Department of Urology- Tanta University Hospitals
Tanta
I, MD, +201060245430, MMohamed.elmaadawy@med.tanta.edu.eg
I Elmaadawy, MD
About this study
Official title: Impact of Initial Drainage Method on Flexible Ureteroscopy Outcomes in Patients Presenting With Calculous Anuria: A Multicenter Prospective Randomized Controlled 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.
Read the detailed description
This is a multicenter prospective randomized controlled trial comparing two emergency drainage strategies before definitive flexible ureteroscopy/retrograde intrarenal surgery in patients presenting with calculous anuria.
Adult patients with calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney will be assessed for eligibility. Eligible participants will be randomized in a 1:1 ratio to emergency retrograde JJ ureteral stent drainage or emergency percutaneous nephrostomy drainage. Randomization will be performed using a computer-generated random sequence, with allocation concealment using sequentially numbered opaque sealed envelopes.
Participants assigned to the JJ stent group will undergo emergency retrograde placement of a 6 Fr JJ ureteral stent under cystoscopic guidance. Participants assigned to the percutaneous nephrostomy group will undergo emergency ultrasound-guided placement of an 8 Fr nephrostomy tube. After drainage, participants will be monitored for urine output recovery, renal functional improvement, symptom relief, and clinical stabilization.
Definitive flexible ureteroscopy/retrograde intrarenal surgery will be scheduled after renal functional improvement, clinical stabilization, and negative or appropriately treated urine culture. The definitive procedure will be performed using a standardized operative strategy. Ureteral access sheath use, successful insertion, need for adjunctive ureteral maneuvers, operative time, laser time, fluoroscopy time, postoperative stenting, complications, and hospital stay will be recorded.
The primary outcome is renal functional recovery after initial drainage and definitive surgery, assessed using serial serum creatinine measurements at presentation, 24 to 48 hours after drainage, before definitive surgery, postoperative day 1, and follow-up. Secondary outcomes include first-session definitive surgery success, stone-free rate, technical operative variables, intraoperative and postoperative complications, microbiological culture patterns, and predictors of surgical success or postoperative complications.
Participants will be followed for approximately one month after definitive surgery by clinical assessment, laboratory evaluation, and imaging for assessment of renal function, complications, and stone clearance.
- Being tested
- Initial JJ Ureteral Stent Drainage, Initial Percutaneous Nephrostomy Drainage
- Keywords
- Percutaneous nephrostomy, Double-J ureteral stent, Retrograde intrarenal surgery
- Medical subject headings
- Ureterolithiasis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial JJ Ureteral Stent DrainageProcedure or surgery
Retrograde 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 DrainageProcedure or surgery
Ultrasound-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.
| Study group | Role | What they receive |
|---|---|---|
| JJ Ureteral Stent Drainage Group | Active comparator | Participants randomized to this arm will undergo emergency retrograde placement of a 6 Fr double-J ureteral stent under cystoscopic guidance for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol. Receives: Procedure: Initial JJ Ureteral Stent Drainage |
| Percutaneous Nephrostomy Drainage Group | Active comparator | Participants randomized to this arm will undergo emergency ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol. Receives: Procedure: Initial Percutaneous Nephrostomy Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS
Secondary outcomes (6)
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.
Measured: During the definitive RIRS procedure
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
Measured: 4 weeks after definitive RIRS
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.
Measured: During the definitive RIRS procedure
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
Measured: At the end of the definitive RIRS procedure
Intraoperative Complications During Definitive RIRS
Intraoperative complications will include ureteral mucosal injury, false passage, ureteral perforation, bleeding affecting visualization, and procedure interruption. The incidence of intraoperative complications will be compared between both drainage groups.
Measured: During the definitive RIRS procedure
Postoperative Infectious Complications After Definitive RIRS
Postoperative infectious complications will include fever greater than 38°C, systemic inflammatory response syndrome, or sepsis after definitive flexible ureteroscopy/retrograde intrarenal surgery. The incidence of postoperative infectious complications will be compared between both drainage groups.
Measured: From definitive RIRS to 4 weeks after definitive RIRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start6 May 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculous AnuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two emergency drainage strategies: retrograde JJ ureteral stent drainage or percutaneous nephrostomy drainage. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Faculty of medicine BeniSuef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627880
- Sponsor's protocol ID
- FMB050526-ANURIA-RIRS
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes individual-level clinical, laboratory, radiological, operative, and microbiological data from patients presenting with an emergency urological condition. Only aggregated and de-identified study results will be reported. Any future sharing of individual participant data would require additional approval from the Research Ethics Committee and an appropriate data-sharing agreement.