About this trial
Bladder stones larger than 2 cm are commonly treated by endoscopic fragmentation through the urethra. During transurethral cystolithotripsy for large stones, the procedure may be prolonged because of poor visibility, stone dust, bladder overdistension, and repeated need for irrigation or evacuation.
This randomized controlled trial will compare standal Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with the same procedure plus an adjunctive 8 Fr suprapubic catheter used only for bladder drainage during the operation. The suprapubic catheter will not be used for stone fragmentation or stone extraction.
The main outcome will be total operative time. Secondary outcomes will include fragmentation and clearance time, laser activation time, total laser energy, irrigation volume, visibility-related interruptions, stone-free rate at 30 days, complications, catheter duration, postoperative pain, and hospital stay.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard Transurethral Holmium Laser Cystolithotripsy
- Adjunctive Suprapubic Catheter Drainage