Clinical trial NCT03294239: Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys
Official title: Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys: A Comparative Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Bladder Stones
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 100
Sex: MALE
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years

Detailed description: Pediatric urolithiasis remains endemic in developing nations, affecting children at ages less than 1 year to adolescence. The prevalence rate is high at 5% to 15% compared with 1% to 5% in developed countries. Recent studies have shown that the percentage of bladder stones in pediatric urolithiasis is 30%.

Open cystolithotomy has been the traditional modality to treat bladder stones. It has the inherent problems of a long scar, prolonged catheterization and hospitalization and risk of wound infection .The advent of improved endoscopic techniques in the form of gradual decrease in endoscopic sizes and the development of effective lithotripters have made trans urethral endoscopic management of bladder stones feasible. Excellent stone-free rates with trans urethral lithotripsy with minimal complications make it a preferred treatment option . However, in children especially boys, the small caliber of urethra raise concerns about the ability of stone fragments clearance and the possibility of iatrogenic urethral stricture occurrence. This renders trans urethral cystolithotripsy to be more difficult and unfavorable .

Per cutaneous cystolithotomy (PCCL) can be a safe alternative with low morbidity and complication rate. It has been performed safely for bladder stones up to 5 cm in size. This procedure may carry many advantages in the form of short operative time, more feasible stone fragments retrieval and less need for stone disintegration with its possible sequel as mucosal perforation or stone escaping inside the bladder that prolong the operative time.

On the other hand PCCL has important disadvantages such as the presence of an incision, the need to dilate a tract and the potential need for a urethral catheter or supra pubic tube. There are other reported complications including paralytic ileus, abdominal distention from escape of irrigating fluid into the abdominal cavity and urine leakage. It also carries a risk of bowel injury especially if there is a history of abdominal or pelvic surgery.

To the best of our knowledge, no previous prospective studies compared between per cutaneous and trans urethral approaches for endoscopic management of bladder stones in male children.

The aim of the study is to compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years.

Eligibility criteria: Inclusion Criteria:

* Boys less than 14 yrs old age with bladder or urethral stones less than 3 cm.

Exclusion Criteria:

* Neurogenic bladder. Augmented bladder. Upper urinary tract stones that needs simultaneous ureteroscopy, PNL or ureteral stent insertion.

Bleeding tendency. Urethral stricture. Stone in fossa navicularis that can be extracted after meatotomy.

Primary outcomes:
measure: stone free state
timeFrame: 1 week post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References: