Should you get a stent before kidney stone surgery with a tiny scope?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two approaches to RIRS for unilateral renal stones 10–20 mm using miniaturized flexible ureteroscopes. One group receives a preoperative double-J stent for 7–14 days before RIRS, while the other group undergoes direct RIRS without planned pre-stenting, with rescue stenting allowed if access is not initially possible. The primary outcome is the stone-free rate on CT at 4 weeks after the final RIRS; secondary outcomes include access success, need for dilation, procedure time, complications, hospital stay, and postoperative symptoms. All procedures use a standardized miniaturized digital flexible ureteroscope and holmium:YAG laser lithotripsy. The trial will help determine if routine pre-stenting improves outcomes or if direct RIRS with modern tools is sufficient.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must meet all of the following criteria:

  * Adults aged 18-70 years.
  * Unilateral renal calculi.
  * Maximum total renal stone burden of 10-20 mm.
  * Planned treatment with RIRS.
  * Suitable candidate for elective endoscopic stone treatment.
  * Negative or appropriately treated preoperative urine culture.
  * Ability to provide written informed consent.
  * Ability and willingness to comply with postoperative follow-up, including non-contrast CT at 4 weeks after the final RIRS procedure.

Exclusion Criteria:

* Participants will be excluded for any of the following:

  * Bilateral renal calculi requiring simultaneous surgical treatment.
  * Active urinary tract infection, sepsis, or infected obstruction requiring urgent drainage.
  * Solitary kidney when randomization is considered clinically unsafe.
  * Known ureteral stricture or congenital ureteral abnormality likely to interfere with ureteroscopic access.
  * Previous failed ipsilateral ureteroscopic access requiring clinically indicated pre-stenting.
  * Existing ipsilateral ureteral stent or nephrostomy.
  * Previous ureteral reconstruction or urinary diversion.
  * Total renal stone burden greater than 20 mm.
  * Staghorn calculi.
  * Uncorrected coagulopathy.
  * Pregnancy.
  * Severe uncorrected cardiopulmonary disease precluding anesthesia.
  * Inability or unwillingness to provide informed consent.
  * Inability or unwillingness to comply with follow-up.
  * Any other condition judged by the treating surgeon to make randomization or RIRS clinically inappropriate or unsafe.

Where it's running

• Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
  Cairo, Egypt Recruiting

Study contacts

• Principal investigator: Abul-fotouh Ahmed, MD — Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
• Study coordinator: Abul-fotouh Ahmed, MD
• Email: abulfotouhahmed@yahoo.com
• Phone: 00201001066756

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Suction to collapse the kidney's collecting system after RIRS (retrograde intrarenal surgery)

  This trial will test whether actively suctioning the kidney's collecting system at the end of RIRS reduces early postoperative pain and infections for adults having kidney stone removal.

  Recruiting Kangdong Sacred Heart Hospital · Gandong-gu, Outside U.S./Canada · NCT07535281

• Comparing three single-use flexible ureteroscopes for treating kidney stones

  This compares three single-use flexible ureteroscopes to see which gives the best results for adults aged 18–60 with kidney stones smaller than 20 mm.

  Recruiting Ain Shams University · Cairo · NCT07360353

• Managing staghorn kidney stones with retrograde intrarenal surgery

  This tests whether a new bendable, suction-enabled ureteral access sheath works better than a standard sheath during retrograde intrarenal surgery for adults with staghorn kidney stones.

  Recruiting Helwan University · Cairo · NCT07342361

• Shock wave treatment versus flexible ureteroscopy for a single 1–2 cm kidney stone

  This research will test whether shock waves from outside the body (ESWL) or a flexible scope with laser (RIRS) works better for adults 18–65 who have a single 1–2 cm kidney stone.

  Recruiting Ziauddin Hospital · Karachi, Sindh · NCT07261995

• Burst wave lithotripsy used during ureteroscopy to break kidney or ureter stones

  This study tests a new ultrasound method called burst wave lithotripsy to try to break kidney or ureter stones during ureteroscopy in adults scheduled for stone removal.

  Recruiting at 2 sites University of Washington · Carmel, Indiana and 1 other locations · NCT03873259

• Break Wave extracorporeal lithotripsy to break kidney stones

  This trial will try the Break Wave machine to break upper urinary tract stones up to 20 mm (10 mm in the lower pole) in adults as an outpatient procedure.

  Recruiting SonoMotion · San Diego, California and 5 other locations · NCT03811171

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.