Suprapubic drainage during laser cystolithotripsy for large bladder stones

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 multicenter, randomized study compares two techniques for transurethral Holmium:YAG laser cystolithotripsy in adults with bladder stones over 2 cm. Both groups use the same laser system and irrigation methods; the experimental group adds an 8 Fr suprapubic catheter for bladder drainage during the procedure. The primary outcome is total operative time, with secondary outcomes including fragmentation and clearance times, laser energy use, irrigation needs, visibility interruptions, stone-free rate at 30 days, complications, catheter duration, pain, and length of hospital stay. Conducted at Beni-Suef University Hospital in Egypt, eligible participants will be randomized 1:1 to either standard transurethral lithotripsy or the same procedure plus suprapubic drainage. Follow-up extends to 30 days post-procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* Radiologically confirmed bladder stone with maximum diameter greater than 2 cm.
* Scheduled for elective transurethral cystolithotripsy.
* Sterile urine culture before surgery, or adequately treated urinary tract infection according to culture sensitivity.
* Fit for spinal or general anesthesia.
* Ability to provide written informed consent.

Exclusion Criteria:

* Urethral stricture preventing safe cystoscopic access.
* Active uncontrolled urinary tract infection or sepsis.
* Neurogenic bladder with severely impaired bladder emptying requiring chronic catheterization.
* History of bladder cancer or suspected bladder tumor requiring simultaneous transurethral resection of bladder tumor.
* Coagulopathy or uncorrected bleeding tendency.
* Patients requiring concomitant transurethral resection of the prostate, Holmium laser enucleation of the prostate, or other prostate surgery in the same session.
* Previous pelvic radiotherapy or major lower urinary tract reconstruction.
* Pregnancy.
* Refusal to participate.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Faculty of Medicine, Beni-Suef University hospital
• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

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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.