Brief Title Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder St
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 con
| Condition(s) | Bladder Stone, Cystolithiasis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 volu |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Beni-Suef University |
| Locations | Banī Suwayf, Beni Suweif Governorate, Egypt |
| Start date | 2026-06-08 |
| NCT ID | NCT07642440 |
| Official listing | https://clinicaltrials.gov/study/NCT07642440 |