Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys

NCT03294239 | Completed

• 1 other identifier: TUEMBS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric Bladder Stones

Outcome Measures

Primary Outcomes (1)

• stone free state

  The number of patients with no residual stone fragments with no need to shift to other modality or auxiliary maneuver

  1 week post operative

Study Arms (2)

Group A (Transurethal group)

EXPERIMENTAL

Patients will have trans urethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone disintegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours.

Procedure: Transurethral extraction of bladder stone(s)

Group B (Percutaneous group)

EXPERIMENTAL

Patients will have per cutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the mid line 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours.

Procedure: percutaneous extraction of bladder stone(s)

Interventions

Transurethral extraction of bladder stone(s) PROCEDURE

Patients will have transurethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone distentegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours.

Group A (Transurethal group)

percutaneous extraction of bladder stone(s) PROCEDURE

Patients will have percutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the midline 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours.

Group B (Percutaneous group)

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 71511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: September 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-09

Locations

EG (1)