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NCT Number: NCT07642440

Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

Location status: Recruiting

Location contact

Hany F Badawy, MD

CONTACT

[email protected]

01149525028

Hany F Badawy, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Total Operative Time

    Time frame: 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 outcomes

  1. Stone Fragmentation and Clearance Time

    Time frame: 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

  2. Total Laser Energy

    Time frame: During the surgical procedure

    Total Holmium:YAG laser energy delivered during cystolithotripsy, recorded in joules from the laser device.

  3. Visibility-Related Interruptions

    Time frame: 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.

  4. Urethral Catheter Duration

    Time frame: 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.

  5. Postoperative Pain Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: SPT-CYSTO Tria

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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