Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones (NCT07642440) | Clinical Trial Compass
RecruitingNot Applicable
Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones
Egypt140 participantsStarted 2026-06-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.