Clinical Trial

Brief Title Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones

Study acronym: SPT-CYSTO Tria
Recruiting
View on ClinicalTrials.gov →
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 volume, visibility-related interruptions, stone-free rate at 30 days, complications, catheter duration, postoperative pain, and hospital stay.
Trial Details
NCT Number NCT07642440
Lead Sponsor Beni-Suef University
Conditions Bladder Stone, Cystolithiasis
Enrollment 140 participants
Start Date 2026-06-08
Primary Completion 2028-05 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-11