<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294239</url>
  </required_header>
  <id_info>
    <org_study_id>TUEMBS</org_study_id>
    <nct_id>NCT03294239</nct_id>
  </id_info>
  <brief_title>Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys</brief_title>
  <official_title>Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys: A Comparative Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic&#xD;
      management of bladder stones in boys younger than 14 years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric urolithiasis remains endemic in developing nations, affecting children at ages less&#xD;
      than 1 year to adolescence. The prevalence rate is high at 5% to 15% compared with 1% to 5%&#xD;
      in developed countries. Recent studies have shown that the percentage of bladder stones in&#xD;
      pediatric urolithiasis is 30%.&#xD;
&#xD;
      Open cystolithotomy has been the traditional modality to treat bladder stones. It has the&#xD;
      inherent problems of a long scar, prolonged catheterization and hospitalization and risk of&#xD;
      wound infection .The advent of improved endoscopic techniques in the form of gradual decrease&#xD;
      in endoscopic sizes and the development of effective lithotripters have made trans urethral&#xD;
      endoscopic management of bladder stones feasible. Excellent stone-free rates with trans&#xD;
      urethral lithotripsy with minimal complications make it a preferred treatment option .&#xD;
      However, in children especially boys, the small caliber of urethra raise concerns about the&#xD;
      ability of stone fragments clearance and the possibility of iatrogenic urethral stricture&#xD;
      occurrence. This renders trans urethral cystolithotripsy to be more difficult and unfavorable&#xD;
      .&#xD;
&#xD;
      Per cutaneous cystolithotomy (PCCL) can be a safe alternative with low morbidity and&#xD;
      complication rate. It has been performed safely for bladder stones up to 5 cm in size. This&#xD;
      procedure may carry many advantages in the form of short operative time, more feasible stone&#xD;
      fragments retrieval and less need for stone disintegration with its possible sequel as&#xD;
      mucosal perforation or stone escaping inside the bladder that prolong the operative time.&#xD;
&#xD;
      On the other hand PCCL has important disadvantages such as the presence of an incision, the&#xD;
      need to dilate a tract and the potential need for a urethral catheter or supra pubic tube.&#xD;
      There are other reported complications including paralytic ileus, abdominal distention from&#xD;
      escape of irrigating fluid into the abdominal cavity and urine leakage. It also carries a&#xD;
      risk of bowel injury especially if there is a history of abdominal or pelvic surgery.&#xD;
&#xD;
      To the best of our knowledge, no previous prospective studies compared between per cutaneous&#xD;
      and trans urethral approaches for endoscopic management of bladder stones in male children.&#xD;
&#xD;
      The aim of the study is to compare safety and efficacy of trans urethral and per cutaneous&#xD;
      approaches in endoscopic management of bladder stones in boys younger than 14 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>stone free state</measure>
    <time_frame>1 week post operative</time_frame>
    <description>The number of patients with no residual stone fragments with no need to shift to other modality or auxiliary maneuver</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pediatric Bladder Stones</condition>
  <arm_group>
    <arm_group_label>Group A (Transurethal group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (Percutaneous group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transurethral extraction of bladder stone(s)</intervention_name>
    <description>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.</description>
    <arm_group_label>Group A (Transurethal group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>percutaneous extraction of bladder stone(s)</intervention_name>
    <description>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.</description>
    <arm_group_label>Group B (Percutaneous group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Boys less than 14 yrs old age with bladder or urethral stones less than 3 cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurogenic bladder. Augmented bladder. Upper urinary tract stones that needs&#xD;
             simultaneous ureteroscopy, PNL or ureteral stent insertion.&#xD;
&#xD;
        Bleeding tendency. Urethral stricture. Stone in fossa navicularis that can be extracted&#xD;
        after meatotomy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <zip>71511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Alaa</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294239
org study id: TUEMBS
nct id: NCT03294239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic
      management of bladder stones in boys younger than 14 years
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: stone free state
time frame: 1 week post operative
description: The number of patients with no residual stone fragments with no need to shift to other modality or auxiliary maneuver
arm group label: Group A (Transurethal group)
arm group type: Experimental
description: 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.
arm group label: Group B (Percutaneous group)
arm group type: Experimental
description: 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.
intervention type: Procedure
intervention name: Transurethral extraction of bladder stone(s)
description: 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.
arm group label: Group A (Transurethal group)
intervention type: Procedure
intervention name: percutaneous extraction of bladder stone(s)
description: 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.
arm group label: Group B (Percutaneous group)
criteria: 
gender: Male
minimum age: 1 Month
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Alaa
investigator title: principal investigator
mesh term: Urinary Bladder Calculi
sharing ipd: Undecided