Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07614880

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Bladder stones in children remain a relevant urological condition, particularly in settings where nutritional, metabolic, infectious, or hydration-related factors may contribute to stone formation. Minimally invasive endoscopic management has largely replaced open cystolithotomy in many centers. Transurethral cystolithotripsy is commonly used, but in young children the small urethral caliber may make repeated instrumentation and fragment extraction technically challenging and may raise concern about urethral mucosal trauma. Percutaneous cystolithotripsy provides an alternative route that may reduce repeated transurethral fragment extraction.

Vacuum-assisted mini-percutaneous cystolithotripsy uses a suprapubic percutaneous access tract and a suction-assisted sheath to maintain visibility and facilitate evacuation of stone dust and fragments during laser lithotripsy. However, pediatric comparative evidence remains limited.

This study is designed as a prospective randomized controlled pilot study including 40 children with bladder stone(s) measuring 10-30 mm. Eligible patients will be randomized in a 1:1 ratio to vacuum-assisted mini-percutaneous cystolithotripsy or transurethral cystolithotripsy. Both procedures will be performed under general anesthesia using Ho:YAG laser lithotripsy. Patients will be followed postoperatively to assess operative, perioperative, and follow-up outcomes. The study aims to generate preliminary comparative data on operative time, safety, stone clearance, postoperative recovery, and follow-up urinary outcomes to inform future adequately powered trials.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. Total Operative Time

    Time frame: Intraoperative

    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.

Secondary outcomes

  1. Stone-Free Rate

    Time frame: 4 weeks postoperatively

    Stone-free rate will be defined as the proportion of patients with no residual bladder stone fragments on postoperative pelvi abdominl ultrasound. Low-dose non-contrast CT urinary tract will be reserved for equivocal ultrasound findings.

    Time Frame: 4 weeks postoperatively

  2. Urethral Mucosal Injury

    Time frame: Intraoperatively

    Occurrence of visible urethral mucosal injury detected intraoperatively.

  3. Lithotripsy and Fragment Clearance Time

    Time frame: Intraoperative

    Time from initiation of laser lithotripsy to endoscopic confirmation of complete stone clearance, measured in minutes.

  4. Recurrence or Urethral Stricture-Related Symptoms

    Time frame: 6 months postoperatively

    Occurrence of recurrent bladder stone symptoms, abnormal urinary stream, suspected urethral stricture symptoms, or need for further diagnostic evaluation

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study

Acronym: VAMPCL-Ped

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 29, 2026
Registry last updated
Jun 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.