Brief Title Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones

NCT07642440 | Recruiting

• 1 other identifier: FMBSUREC-07062026a-Badawy
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Stone; Cystolithiasis

Keywords

Transurethral cystolithotripsy; Suprapubic drainage; Suprapubic catheter

Outcome Measures

Primary Outcomes (1)

• Total Operative Time

  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

  During the surgical procedure

Secondary Outcomes (5)

• Stone Fragmentation and Clearance Time

  During the surgical procedure

• Total Laser Energy

  During the surgical procedure

• Visibility-Related Interruptions

  During the surgical procedure

• Urethral Catheter Duration

  From end of surgery until catheter removal, up to 30 days

• Postoperative Pain Score

  6 hours and 24 hours after surgery

Study Arms (2)

Standard Transurethral Cystolithotripsy

ACTIVE COMPARATOR

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.

Procedure: Standard Transurethral Holmium Laser Cystolithotripsy

Transurethral Cystolithotripsy With Suprapubic Drainage

EXPERIMENTAL

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

Procedure: Adjunctive Suprapubic Catheter Drainage

Interventions

Adjunctive Suprapubic Catheter Drainage PROCEDURE

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.

Transurethral Cystolithotripsy With Suprapubic Drainage

Standard Transurethral Holmium Laser Cystolithotripsy PROCEDURE

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.

Standard Transurethral Cystolithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Calculi

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Urolithiasis; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hany F Badawy, MD

  Faculty of Medicine, Beni-Suef University hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: 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

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)