NCT07642440 Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones
| NCT ID | NCT07642440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beni-Suef University |
| Condition | Bladder Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2026-06-08 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Hany F Badawy, MD
PRINCIPAL INVESTIGATOR
Faculty of Medicine, Beni-Suef University hospital
Frequently Asked Questions
Who can join the NCT07642440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07642440 currently recruiting?
Yes, NCT07642440 is actively recruiting participants. Contact the research team at HANYFATHY86@GMAIL.COM for enrollment information.
Where is the NCT07642440 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07642440 clinical trial?
NCT07642440 is sponsored by Beni-Suef University. The principal investigator is Hany F Badawy, MD at Faculty of Medicine, Beni-Suef University hospital. The trial plans to enroll 140 participants.