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RECRUITING
NCT07642440
NA

Brief Title Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones

Sponsor: Beni-Suef University

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-06-08

Completion Date

2028-06

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

PROCEDURE

Standard Transurethral Holmium Laser Cystolithotripsy

Standardized 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.

PROCEDURE

Adjunctive Suprapubic Catheter Drainage

Insertion 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.

Locations (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt