Bladder Stone, Cystolithiasis
Conditions
Keywords
Transurethral cystolithotripsy, Suprapubic drainage, Suprapubic catheter
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.
Detailed description
This is a prospective, randomized, controlled, parallel-group clinical trial conducted at the Department of Urology, Beni-Suef University Hospital, Faculty of Medicine, Beni-Suef University, Egypt. Adult patients with radiologically confirmed bladder stones greater than 2 cm who are scheduled for elective transurethral cystolithotripsy will be enrolled after written informed consent. Participants will be randomized in a 1:1 ratio into two groups. The control group will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only. The experimental group will undergo the same procedure with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization. The suprapubic catheter will be connected to free drainage during lithotripsy to assist bladder decompression and irrigation outflow. It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy. All procedures will use the same standardized cystoscopic access, Holmium:YAG laser platform, irrigation system, and transurethral evacuation method. The primary outcome is total operative time, measured from cystoscope insertion into the urethra until endoscopic confirmation of complete stone clearance and completion of final urethral catheter placement. Postoperative follow-up will continue for 30 days, including assessment of stone-free status by imaging and recording of perioperative complications.
Interventions
PROCEDUREStandard 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.
PROCEDUREAdjunctive 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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Surgeon blinding is not feasible because of the nature of the intervention. Postoperative outcome assessment, including 30-day imaging assessment of stone-free status and complication review, will be performed by an outcome assessor not involved in the surgical procedure whenever feasible. Data analysis will be performed using coded groups.
Intervention model description
Participants will be randomized in a 1:1 ratio to undergo standardized transurethral holmium laser cystolithotripsy using a 17 Fr cystoscope sheath either without adjunctive suprapubic drainage or with adjunctive 8 Fr suprapubic catheter drainage
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Operative Time | During the surgical procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone Fragmentation and Clearance Time | During the surgical procedure | Time measured in minutes from the start of Holmium:YAG laser lithotripsy until endoscopic confirmation of complete bladder stone fragmentation and clearance |
| Total Laser Energy | During the surgical procedure | Total Holmium:YAG laser energy delivered during cystolithotripsy, recorded in joules from the laser device. |
| Visibility-Related Interruptions | During the surgical procedure | Number of intraoperative interruptions of lithotripsy due to poor endoscopic vision, stone dust, bladder overdistension, clot, or need for evacuation or irrigation adjustment. |
| Urethral Catheter Duration | From end of surgery until catheter removal, up to 30 days | Duration of postoperative urethral Foley catheterization, measured from the end of surgery until catheter removal. |
| Postoperative Pain Score | 6 hours and 24 hours after surgery | Postoperative pain will be assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. |
Countries
Egypt
Contacts
CONTACTHany F Badawy, MD
PRINCIPAL_INVESTIGATORHany F Badawy, MD
Faculty of Medicine, Beni-Suef University hospital
Outcome results
None listed