Bladder Stones Clinical Trials

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Transurethral Cystolithotripsy With Versus Without Adjunctive Suprapubic Tube Drainage for Bladder Stones >2 cm: A Prospective Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Department of Urology- Beni-Suef University Hospitals
RECRUITING
Banī Suwayf
Contact Information
Primary
Hany F Badawy, MD
HANYFATHY86@GMAIL.COM
+201149525028
Time Frame
Start Date: 2026-06-08
Estimated Completion Date: 2028-06
Participants
Target number of participants: 140
Treatments
Active_comparator: Standard Transurethral Cystolithotripsy
Participants assigned to this arm will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only, without adjunctive suprapubic catheter drainage.
Experimental: Transurethral Cystolithotripsy With Suprapubic Drainage
Participants assigned to this arm will undergo the same standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath, with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization for bladder drainage and decompression during lithotripsy. No stone fragmentation or extraction will be performed through the suprapubic route
Related Therapeutic Areas
Sponsors
Leads: Beni-Suef University

This content was sourced from clinicaltrials.gov