<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/NCT02207608</url>
  </required_header>
  <id_info>
    <org_study_id>EA-1</org_study_id>
    <nct_id>NCT02207608</nct_id>
  </id_info>
  <brief_title>Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects</brief_title>
  <official_title>Pilot Study of Influence of Hyaluronic Acid (HA) on Bacillus Calmette-Guérin (BCG) Local Side Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rome Tor Vergata</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rome Tor Vergata</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in&#xD;
      reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial&#xD;
      cell carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bacillus Calmette-Guérin (BCG) is considered the most effective treatment to increase&#xD;
      disease-free interval and reduce progression of non-muscle invasive bladder cancer (NMIBC)&#xD;
      [1]. Although considered safe, BCG can produce both local and systemic side effects leading&#xD;
      to treatment discontinuation or interruption. The most common local side-effects of BCG&#xD;
      intravesical instillations include cystitis, characterized by irritative voiding symptoms and&#xD;
      hematuria, which occur in approximately 75% of all patients. More rarely, serious local&#xD;
      adverse events as a result of BCG infection, such as symptomatic granulomatous prostatitis&#xD;
      and epididymo-orchitis, might occur and require permanent discontinuation of BCG treatment.&#xD;
      Systemic side-effects include flu-like symptoms, such as general malaise and fever, occuring&#xD;
      in approximately 40% of patients. A high persistent fever might be related to BCG infection&#xD;
      or sepsis. Local and systemic side-effects might lead to discontinue intravesical BCG&#xD;
      treatment in approximately 20% of patients [2]. Up to 54% of the patients undergoing&#xD;
      intravesical therapy with chemotherapeutic agents to treat superficial bladder tumours can be&#xD;
      affected by nonbacterial cystitis [3].&#xD;
&#xD;
      Several solutions have been proposed to reduce the occurrence of side effects from BCG with&#xD;
      the aim to limit BCG discontinuation and the concomitant discomfort during endovesical&#xD;
      treatment. Some Authors have proposed to avoid BCG administration in case of TUR within&#xD;
      previous 2 weeks, traumatic catheterization, macroscopic hematuria, urethral stenosis, active&#xD;
      tuberculosis, prior Bacillus Calmette-Guérin sepsis, immuno-suppression or urinary tract&#xD;
      infection [4]. Other procedures include the prophylactic administration of isoniazid [5] or&#xD;
      ofloxacin [6,7] or usually involve BCG dose reductions [8]. In common practice&#xD;
      antimicrobials, anticholinergics, anaesthetics and analgesics are often used to relieve&#xD;
      patients' symptoms.&#xD;
&#xD;
      Glycosaminoglycan (GAG) substitution therapy is an emerging treatment of Bladder Pain&#xD;
      Syndrome/Interstitial Cystitis (BPS/IC) and response rates between 30% and 80% have been&#xD;
      described with intravesical administration of various GAGs (hyaluronic acid, pentosan&#xD;
      polysulfate, heparin, chondroitin sulfate, and dimethyl sulfoxide) [9,10]. Few papers report&#xD;
      the results of GAG substitution therapy in the treatment of radiation and chemical cystitis&#xD;
      [9,10]. To our knowledge, to date, only two papers have described GAG use in the treatment of&#xD;
      BCG local side effects; this papers show very good results, with significant reduction of&#xD;
      lower urinary tract symptoms after intravesical administration of HA [11,12].&#xD;
&#xD;
      Aim of the present randomized pilot study was to evaluate if the sequential administration of&#xD;
      HA and BCG could be safe in prevention of early recurrence and progression of bladder tumor,&#xD;
      and safe in reduction of local side-effects in patients with high risk NMIBC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale for Pain</measure>
    <time_frame>Before and after six weeks of treatment (end of induction course)</time_frame>
    <description>1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Poisoning by BCG Vaccine</condition>
  <arm_group>
    <arm_group_label>BCG alone (Immucist®)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyaluronic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyaluronic Acid</intervention_name>
    <description>Add hyaluronic acid to BCG Treatment</description>
    <arm_group_label>Hyaluronic acid</arm_group_label>
    <other_name>Cystistat (Mylan, Pittsburgh, PA, U.S.A.)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BCG (Immucist®)</intervention_name>
    <description>Usual BCG treatment</description>
    <arm_group_label>BCG alone (Immucist®)</arm_group_label>
    <arm_group_label>Hyaluronic acid</arm_group_label>
    <other_name>BCG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven non-muscle invasive bladder cancer;&#xD;
&#xD;
          -  Indication to intravesical instillation of BCG according to EAU guidelines;&#xD;
&#xD;
          -  Age &gt; 18 years;&#xD;
&#xD;
          -  Willingness, to participate to the study;&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or ongoing BCG or different intravesical instillations;&#xD;
&#xD;
          -  Urinary tract infections (UTI) or other known pathologies of the lower urinary tract;&#xD;
&#xD;
          -  Indication for a radical cystectomy;&#xD;
&#xD;
          -  Severe systemic disorders, including neurological pathologies, kidney, liver or heart&#xD;
             failure;&#xD;
&#xD;
          -  Contraindications to BCG use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>December 1, 2014</results_first_submitted>
  <results_first_submitted_qc>May 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 28, 2015</results_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rome Tor Vergata</investigator_affiliation>
    <investigator_full_name>Enrico Finazzi Agro</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>BCG</keyword>
  <keyword>hyaluronic acid</keyword>
  <keyword>non-muscle invasive bladder cancer</keyword>
  <keyword>non bacterial cystitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BCG Alone (Immucist®)</title>
          <description>Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone&#xD;
BCG (Immucist®)</description>
        </group>
        <group group_id="P2">
          <title>Hyaluronic Acid</title>
          <description>Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).&#xD;
Hyaluronic Acid&#xD;
BCG (Immucist®)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>BCG Alone (Immucist®)</title>
          <description>Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone&#xD;
BCG (Immucist®)</description>
        </group>
        <group group_id="B2">
          <title>Hyaluronic Acid</title>
          <description>Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).&#xD;
Hyaluronic Acid&#xD;
BCG (Immucist®)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" lower_limit="60" upper_limit="81"/>
                    <measurement group_id="B2" value="68" lower_limit="54" upper_limit="75"/>
                    <measurement group_id="B3" value="67" lower_limit="54" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale for Pain</title>
        <description>1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)</description>
        <time_frame>Before and after six weeks of treatment (end of induction course)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BCG Alone (Immucist®)</title>
            <description>Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone&#xD;
BCG (Immucist®)</description>
          </group>
          <group group_id="O2">
            <title>Hyaluronic Acid</title>
            <description>Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).&#xD;
Hyaluronic Acid&#xD;
BCG (Immucist®)</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale for Pain</title>
          <description>1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Data Before treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2"/>
                    <measurement group_id="O2" value="4.9" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Data after treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="1"/>
                    <measurement group_id="O2" value="4.2" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>BCG Alone (Immucist®)</title>
          <description>Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone&#xD;
BCG (Immucist®)</description>
        </group>
        <group group_id="E2">
          <title>Hyaluronic Acid</title>
          <description>Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).&#xD;
Hyaluronic Acid&#xD;
BCG (Immucist®)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Enrico Finazzi Agro</name_or_title>
      <organization>University of Rome Tor Vergata</organization>
      <phone>+393296152920</phone>
      <email>efinazzi@tin.it</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02207608
org study id: EA-1
nct id: NCT02207608
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in
      reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial
      cell carcinoma.
Bacillus Calmette-Guérin (BCG) is considered the most effective treatment to increase
      disease-free interval and reduce progression of non-muscle invasive bladder cancer (NMIBC)
      [1]. Although considered safe, BCG can produce both local and systemic side effects leading
      to treatment discontinuation or interruption. The most common local side-effects of BCG
      intravesical instillations include cystitis, characterized by irritative voiding symptoms and
      hematuria, which occur in approximately 75% of all patients. More rarely, serious local
      adverse events as a result of BCG infection, such as symptomatic granulomatous prostatitis
      and epididymo-orchitis, might occur and require permanent discontinuation of BCG treatment.
      Systemic side-effects include flu-like symptoms, such as general malaise and fever, occuring
      in approximately 40% of patients. A high persistent fever might be related to BCG infection
      or sepsis. Local and systemic side-effects might lead to discontinue intravesical BCG
      treatment in approximately 20% of patients [2]. Up to 54% of the patients undergoing
      intravesical therapy with chemotherapeutic agents to treat superficial bladder tumours can be
      affected by nonbacterial cystitis [3].

      Several solutions have been proposed to reduce the occurrence of side effects from BCG with
      the aim to limit BCG discontinuation and the concomitant discomfort during endovesical
      treatment. Some Authors have proposed to avoid BCG administration in case of TUR within
      previous 2 weeks, traumatic catheterization, macroscopic hematuria, urethral stenosis, active
      tuberculosis, prior Bacillus Calmette-Guérin sepsis, immuno-suppression or urinary tract
      infection [4]. Other procedures include the prophylactic administration of isoniazid [5] or
      ofloxacin [6,7] or usually involve BCG dose reductions [8]. In common practice
      antimicrobials, anticholinergics, anaesthetics and analgesics are often used to relieve
      patients' symptoms.

      Glycosaminoglycan (GAG) substitution therapy is an emerging treatment of Bladder Pain
      Syndrome/Interstitial Cystitis (BPS/IC) and response rates between 30% and 80% have been
      described with intravesical administration of various GAGs (hyaluronic acid, pentosan
      polysulfate, heparin, chondroitin sulfate, and dimethyl sulfoxide) [9,10]. Few papers report
      the results of GAG substitution therapy in the treatment of radiation and chemical cystitis
      [9,10]. To our knowledge, to date, only two papers have described GAG use in the treatment of
      BCG local side effects; this papers show very good results, with significant reduction of
      lower urinary tract symptoms after intravesical administration of HA [11,12].

      Aim of the present randomized pilot study was to evaluate if the sequential administration of
      HA and BCG could be safe in prevention of early recurrence and progression of bladder tumor,
      and safe in reduction of local side-effects in patients with high risk NMIBC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analogue Scale for Pain
time frame: Before and after six weeks of treatment (end of induction course)
description: 1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)
arm group label: BCG alone (Immucist®)
arm group type: Active Comparator
description: Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
arm group label: Hyaluronic acid
arm group type: Experimental
description: Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
intervention type: Drug
intervention name: Hyaluronic Acid
description: Add hyaluronic acid to BCG Treatment
arm group label: Hyaluronic acid
other name: Cystistat (Mylan, Pittsburgh, PA, U.S.A.)
intervention type: Drug
intervention name: BCG (Immucist®)
description: Usual BCG treatment
arm group label: BCG alone (Immucist®)
arm group label: Hyaluronic acid
other name: BCG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Rome Tor Vergata
investigator full name: Enrico Finazzi Agro
investigator title: Associate Professor
mesh term: Poisoning
mesh term: Hyaluronic Acid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 