Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones

NCT07614880 | Recruiting

• 2 other identifiers: FMBSUREC03032026AhmedFMBSUREC/03032026/Ahmed
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized pilot study will compare vacuum-assisted mini-percutaneous cystolithotripsy with standard transurethral cystolithotripsy for the treatment of bladder stones in children. Forty children aged 2 to 14 years with bladder stone(s) measuring 10 -30 mm will be randomly assigned to one of two surgical approaches. The vacuum-assisted mini-percutaneous group will undergo suprapubic percutaneous access using a mini sheath with suction-assisted fragment evacuation, while the transurethral group will undergo standard transurethral cystolithotripsy. The primary outcome will be total operative time. Secondary outcomes will include stone-free rate ,lithotripsy time and fragment clearance time, urethral mucosal injury, postoperative hematuria, fever, urinary tract infection, sepsis, urinary retention, urinary leakage from the suprapubic tract, catheterization time, hospital stay, postoperative pain, analgesic requirement, need for auxiliary procedures or conversion, and recurrence or urethral stricture-related symptoms during follow-up.

Conditions

Pediatric Bladder Stones; Bladder Calculi; Pediatric Urolithiasis

Keywords

Pediatric bladder stones; Mini-percutaneous cystolithotripsy; Vacuum-assisted cystolithotripsy; Ho:YAG laser lithotripsy

Outcome Measures

Primary Outcomes (1)

• Total Operative Time

  Total operative time will be defined as the time from insertion of the first endoscopic instrument to completion of stone clearance and urethral catheter placement, measured in minutes.

  Intraoperative

Secondary Outcomes (4)

• Stone-Free Rate

  4 weeks postoperatively

• Urethral Mucosal Injury

  Intraoperatively

• Lithotripsy and Fragment Clearance Time

  Intraoperative

• Recurrence or Urethral Stricture-Related Symptoms

  6 months postoperatively

Study Arms (2)

Vacuum-Assisted Mini-Percutaneous Cystolithotripsy

EXPERIMENTAL

Participants randomized to this arm will undergo vacuum-assisted mini-percutaneous cystolithotripsy under general anesthesia using suprapubic percutaneous bladder access and a suction-assisted mini sheath. Ho:YAG laser lithotripsy will be used for stone fragmentation, with suction-assisted evacuation of stone dust and fragments.

Procedure: Vacuum-Assisted Mini-Percutaneous Cystolithotripsy

Transurethral Cystolithotripsy

ACTIVE COMPARATOR

Participants randomized to this arm will undergo standard transurethral cystolithotripsy under general anesthesia using the smallest appropriate pediatric semi-rigid ureteroscope. Ho:YAG laser lithotripsy will be used for stone fragmentation, with fragment evacuation through the transurethral route

Procedure: Transurethral Cystolithotripsy

Interventions

Vacuum-Assisted Mini-Percutaneous Cystolithotripsy PROCEDURE

Surgical treatment of pediatric bladder stones using suprapubic mini-percutaneous bladder access, a suction-assisted mini sheath, and Ho:YAG laser lithotripsy for stone fragmentation and evacuation

Vacuum-Assisted Mini-Percutaneous Cystolithotripsy

Transurethral Cystolithotripsy PROCEDURE

Standard transurethral endoscopic treatment of pediatric bladder stones using an appropriate pediatric semi-rigid ureteroscope with Ho:YAG laser lithotripsy and transurethral fragment evacuation

Transurethral Cystolithotripsy

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2 to 14 years.
• Diagnosis of bladder stone or stones measuring 10-30 mm in maximum cumulative diameter, confirmed by ultrasound.
• Normal upper urinary tract.
• Fit for general anesthesia.
• Written informed consent obtained from parents or legal guardians.

You may not qualify if:

• Known urethral stricture or posterior urethral valves.
• Active urinary tract infection at the time of surgery.
• Coagulopathy or uncorrected bleeding disorder.
• Previous open bladder surgery.
• Any anatomical or clinical condition that, in the investigator's judgment, precludes safe endoscopic or percutaneous cystolithotripsy.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Urology Department - 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operating surgeon and patients' guardians will not be masked because of the surgical nature of the interventions. Postoperative imaging assessment for stone-free status will be performed by a radiologist or outcomes assessor masked to treatment allocation.
• 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 either vacuum-assisted mini-percutaneous cystolithotripsy or transurethral cystolithotripsy.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)