Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard Transurethral Holmium Laser Cystolithotripsy
Procedure/SurgeryStandardized transurethral Holmium:YAG laser cystolithotripsy performed through a 17 Fr cystoscope sheath, with conventional irrigation and transurethral evacuation of stone dust and fragments. A urethral Foley catheter will be inserted at the end of the procedure. This procedure will be performed in both study arms.
Adjunctive Suprapubic Catheter Drainage
Procedure/SurgeryInsertion of an 8 Fr suprapubic catheter under ultrasound guidance and cystoscopic visualization during transurethral cystolithotripsy. The catheter will be connected to free drainage to assist bladder decompression and irrigation outflow during lithotripsy. It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Standard Transurethral CystolithotripsyActive comparator 1 intervention
Group B: Transurethral Cystolithotripsy With Suprapubic DrainageExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total Operative Time
Total operative time will be measured in minutes from insertion of the cystoscope into the urethra until endoscopic confirmation of complete bladder stone clearance and completion of final urethral catheter placement. In the suprapubic drainage group, the time required for insertion of the 8 Fr suprapubic catheter will be included because the study evaluates the overall procedural efficiency of adding adjunctive suprapubic cathe+ drainage
Time frame
During the surgical procedureSecondary outcomes
1
Stone Fragmentation and Clearance Time
Time measured in minutes from the start of Holmium:YAG laser lithotripsy until endoscopic confirmation of complete bladder stone fragmentation and clearance
Time frame
During the surgical procedure2
Total Laser Energy
Total Holmium:YAG laser energy delivered during cystolithotripsy, recorded in joules from the laser device.
Time frame
During the surgical procedure3
Visibility-Related Interruptions
Number of intraoperative interruptions of lithotripsy due to poor endoscopic vision, stone dust, bladder overdistension, clot, or need for evacuation or irrigation adjustment.
Time frame
During the surgical procedure4
Urethral Catheter Duration
Duration of postoperative urethral Foley catheterization, measured from the end of surgery until catheter removal.
Time frame
From end of surgery until catheter removal, up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov