Kidney StoneNCT05738304
Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones
A study testing Retrograde intrarenal surgery with external ureteral catheter and Retrograde intrarenal surgery with double J internal ureteral stent in people with Kidney Stone and Retrograde Intrarenal Surgery, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Retrograde Intrarenal Surgery, Ureteral Stent
- What is being tested?
- Retrograde intrarenal surgery with external ureteral catheter and Retrograde intrarenal surgery with double J internal ureteral stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2021to 1 Jan 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
- Adult patients of either gender in whom RIRS was the primary modality.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Urology Department, Al-Azhar University Hospital
Cairo
Ahmed Fahim, MD, 002025107333, urologyhospital@gmail.com
About this study
Official title: One-Day External Ureteral Catheter Versus Double-J Internal Ureteral Stent After Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized 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.
- Conditions
- Kidney Stone, Retrograde Intrarenal Surgery, Ureteral Stent
- Being tested
- Retrograde intrarenal surgery with external ureteral catheter, Retrograde intrarenal surgery with double J internal ureteral stent
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgery with external ureteral catheterProcedure or 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 stentProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| External Ureteral Catheter group | Experimental | After RIRS, an external ureteral catheter will be placed for one day. Receives: Procedure: Retrograde intrarenal surgery with external ureteral catheter |
| Double J group | Active comparator | After RIRS, a double J internal ureteral stent will be placed for 2 weeks. Receives: Procedure: Retrograde intrarenal surgery with double J internal ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
No stones or residual fragments >3 mm on postoperative imaging study
Measured: up to 1 month
Stent-related symptoms
Irritative lower urinary tract symptoms
Measured: from post operative day one till double J removal; an average of 2 weeks
Secondary outcomes (3)
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).
Measured: up to 1 month
Rehospitalization rate
the need for unscheduled hospital admission
Measured: From post RIRS home discharge up to one month
Reintervention rate
the need for reoperation
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start12 Jan 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
- Investigators
- Abul-fotouh Ahmed, Principal investigator, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738304
- Sponsor's protocol ID
- Uro_Azhar_11_023
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No