<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/NCT01725984</url>
  </required_header>
  <id_info>
    <org_study_id>MC1201</org_study_id>
    <nct_id>NCT01725984</nct_id>
  </id_info>
  <brief_title>AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up</brief_title>
  <official_title>AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Medical Systems</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American Medical Systems</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-center retrospective chart review of AdVance and AdVance XP subject data, combined&#xD;
      with prospective follow-up of the same subjects to confirm continence, adverse event, and&#xD;
      quality of life status. This study includes patients previously implanted with an AdVance or&#xD;
      AdVance XP male sling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single-center retrospective chart review of AdVance and AdVance XP subject data, combined&#xD;
      with prospective follow-up of the same subjects to confirm continence, adverse event, and&#xD;
      quality of life status. This study includes patients previously implanted with an AdVance or&#xD;
      AdVance XP male sling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use</measure>
    <time_frame>3 Months Post Procedure</time_frame>
    <description>Evaluate the proportion of subjects with a ≥50% reduction in pads per day use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use</measure>
    <time_frame>3 months Post Procedure</time_frame>
    <description>Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</measure>
    <time_frame>Baseline</time_frame>
    <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit</measure>
    <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
    <description>Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.</measure>
    <time_frame>Baseline to Prospective Follow Up (up to 36 months)</time_frame>
    <description>The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.&#xD;
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.&#xD;
The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Adverse Events Reported Between Arms</measure>
    <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
    <description>Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use</measure>
    <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
    <description>Evaluate the proportion of subjects with a ≥50% reduction in pads per day use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use</measure>
    <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
    <description>Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</measure>
    <time_frame>3 Months Post Procedure</time_frame>
    <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</measure>
    <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
    <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Urinary Incontinence, Stress</condition>
  <condition>Intrinsic Sphincter Deficiency</condition>
  <arm_group>
    <arm_group_label>AdVance</arm_group_label>
    <description>Subjects previously implanted with the AdVance Male Sling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AdVance XP</arm_group_label>
    <description>Subjects previously implanted with the AdVance XP male sling</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or&#xD;
        the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI at&#xD;
        one institution in Munich, Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Valid, written informed consent has been obtained&#xD;
&#xD;
          2. Male subject ≥40 years of age who received the AdVance male sling after January 1,&#xD;
             2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post&#xD;
             prostatectomy SUI&#xD;
&#xD;
          3. Pad use of 1 to 8 pads per day prior to sling placement (subjects who used only a dry&#xD;
             prophylactic pad or safety liner at baseline will not be included)&#xD;
&#xD;
          4. External (distal) sphincter contractility and a coaptive zone of ≥ 1cm confirmed by&#xD;
             endoscopic view prior to sling placement&#xD;
&#xD;
          5. Primary etiology of SUI resulting from radical prostatectomy including, simple open&#xD;
             prostatectomy, robotic or laparoscopic prostatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pad use of more than 8 pads per day prior to sling placement for incontinence&#xD;
             management&#xD;
&#xD;
          2. Urine loss while lying in bed prior to sling placement&#xD;
&#xD;
          3. Treatment with a urethral sling system, an AMS Sphincter 800®, or any implanted device&#xD;
             for the treatment of urinary incontinence (not including bulking agents) prior to&#xD;
             sling placement&#xD;
&#xD;
          4. TURP procedure prior to sling placement&#xD;
&#xD;
          5. Urge predominant incontinence prior to sling placement&#xD;
&#xD;
          6. Past or current neurological disorder (e.g. neurogenic bladder, multiple sclerosis,&#xD;
             Parkinson's disease)&#xD;
&#xD;
          7. History of connective tissue or autoimmune conditions&#xD;
&#xD;
          8. Past or current condition of compromised immune system&#xD;
&#xD;
          9. Placement of an inflatable penile prosthesis (IPP) after sling placement&#xD;
&#xD;
         10. Post void residual of &gt;50 ml prior to sling placement&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricarda Bauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians Universität (LMU)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ludwig-Maximilians Universität (LMU)</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <results_first_submitted>March 17, 2015</results_first_submitted>
  <results_first_submitted_qc>June 25, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 30, 2015</results_first_posted>
  <last_update_submitted>June 25, 2015</last_update_submitted>
  <last_update_submitted_qc>June 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Male Incontinence</keyword>
  <keyword>AdVance Male Sling</keyword>
  <keyword>AdVance XP Male Sling</keyword>
  <keyword>Male Sling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>140 subjects were screened for inclusion into the study. 80 total subjects met all inclusion and none of the exclusion criteria.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>AdVance</title>
          <description>Subjects previously implanted with the AdVance Male Sling</description>
        </group>
        <group group_id="P2">
          <title>AdVance XP</title>
          <description>Subjects previously implanted with the AdVance XP male sling</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AdVance</title>
          <description>Subjects previously implanted with the AdVance Male Sling</description>
        </group>
        <group group_id="B2">
          <title>AdVance XP</title>
          <description>Subjects previously implanted with the AdVance XP male sling</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="39"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.2" spread="4.9"/>
                    <measurement group_id="B2" value="68.8" spread="5.3"/>
                    <measurement group_id="B3" value="69.5" spread="5.1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="80"/>
                  </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>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use</title>
        <description>Evaluate the proportion of subjects with a ≥50% reduction in pads per day use</description>
        <time_frame>3 Months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use</title>
          <description>Evaluate the proportion of subjects with a ≥50% reduction in pads per day use</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2"/>
                    <measurement group_id="O2" value="97.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use</title>
        <description>Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit</description>
        <time_frame>3 months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use</title>
          <description>Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.5"/>
                    <measurement group_id="O2" value="82.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</title>
        <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</title>
          <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Pad per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5"/>
                    <measurement group_id="O2" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                    <measurement group_id="O2" value="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5"/>
                    <measurement group_id="O2" value="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 or more Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8"/>
                    <measurement group_id="O2" value="36.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit</title>
        <description>Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.</description>
        <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit</title>
          <description>Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;= 10g</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.0"/>
                    <measurement group_id="O2" value="68.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10g - 50g</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8"/>
                    <measurement group_id="O2" value="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 50g</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3"/>
                    <measurement group_id="O2" value="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.</title>
        <description>The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.&#xD;
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.&#xD;
The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.</description>
        <time_frame>Baseline to Prospective Follow Up (up to 36 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.</title>
          <description>The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.&#xD;
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.&#xD;
The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.</description>
          <units>Score 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="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IQOL Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.5" spread="21.0"/>
                    <measurement group_id="O2" value="45.6" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IQOL 3 Month FU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4" spread="21.5"/>
                    <measurement group_id="O2" value="85.4" spread="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IQOL Prospective FU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.9" spread="21.7"/>
                    <measurement group_id="O2" value="86.8" spread="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICIQ-SF Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="5.1"/>
                    <measurement group_id="O2" value="15.9" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICIQ-SF 3 Month FU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="5.4"/>
                    <measurement group_id="O2" value="4.1" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICIQ-SF Prospective FU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="5.6"/>
                    <measurement group_id="O2" value="5.2" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGI-I Prospective FU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.1"/>
                    <measurement group_id="O2" value="1.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Adverse Events Reported Between Arms</title>
        <description>Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events</description>
        <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events Reported Between Arms</title>
          <description>Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events</description>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Number of AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Procedure Related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device Related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intra-operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use</title>
        <description>Evaluate the proportion of subjects with a ≥50% reduction in pads per day use</description>
        <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use</title>
          <description>Evaluate the proportion of subjects with a ≥50% reduction in pads per day use</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2"/>
                    <measurement group_id="O2" value="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use</title>
        <description>Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit</description>
        <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use</title>
          <description>Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2"/>
                    <measurement group_id="O2" value="65.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1"/>
                    <measurement group_id="O2" value="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8"/>
                    <measurement group_id="O2" value="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</title>
        <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
        <time_frame>3 Months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</title>
          <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.1"/>
                    <measurement group_id="O2" value="86.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Pad per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7"/>
                    <measurement group_id="O2" value="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2"/>
                    <measurement group_id="O2" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</title>
        <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
        <time_frame>Prospective follow-up to 36 Months Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AdVance</title>
            <description>Subjects previously implanted with the AdVance Male Sling</description>
          </group>
          <group group_id="O2">
            <title>AdVance XP</title>
            <description>Subjects previously implanted with the AdVance XP male sling</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use</title>
          <description>Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:&#xD;
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2"/>
                    <measurement group_id="O2" value="65.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Pad per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1"/>
                    <measurement group_id="O2" value="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3"/>
                    <measurement group_id="O2" value="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                    <measurement group_id="O2" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 or more Pads per Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AdVance</title>
          <description>Subjects implanted with the AdVance Male Sling</description>
        </group>
        <group group_id="E2">
          <title>AdVance XP</title>
          <description>Subjects implanted with the AdVance XP Male Sling</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Incontinence De Novo (Urge)</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Pain/Discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </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="6" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated Post-Void Residual (PVR)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Superficial Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence- De Novo (Stress)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence- De Novo (Urge)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence- Worsening Urge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary Urgency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </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>Dr. Ricarda Bauer</name_or_title>
      <organization>Ludwig Maximilian Universität</organization>
      <phone>+49 89 7095</phone>
      <email>Ricarda.Bauer@med.uni-muenchen.de</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/NCT01725984
org study id: MC1201
nct id: NCT01725984
lead sponsor: 
has dmc: No
A single-center retrospective chart review of AdVance and AdVance XP subject data, combined
      with prospective follow-up of the same subjects to confirm continence, adverse event, and
      quality of life status. This study includes patients previously implanted with an AdVance or
      AdVance XP male sling.
A single-center retrospective chart review of AdVance and AdVance XP subject data, combined
      with prospective follow-up of the same subjects to confirm continence, adverse event, and
      quality of life status. This study includes patients previously implanted with an AdVance or
      AdVance XP male sling.
observational model: Cohort
measure: Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
time frame: 3 Months Post Procedure
description: Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
measure: Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
time frame: 3 months Post Procedure
description: Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
measure: Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
time frame: Baseline
description: Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
measure: Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit
time frame: Prospective follow-up to 36 Months Post Procedure
description: Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.
measure: Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.
time frame: Baseline to Prospective Follow Up (up to 36 months)
description: The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.
The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.
measure: Number of Adverse Events Reported Between Arms
time frame: Prospective follow-up to 36 Months Post Procedure
description: Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events
measure: Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
time frame: Prospective follow-up to 36 Months Post Procedure
description: Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
measure: Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
time frame: Prospective follow-up to 36 Months Post Procedure
description: Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
measure: Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
time frame: 3 Months Post Procedure
description: Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
measure: Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
time frame: Prospective follow-up to 36 Months Post Procedure
description: Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:
0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
arm group label: AdVance
description: Subjects previously implanted with the AdVance Male Sling
arm group label: AdVance XP
description: Subjects previously implanted with the AdVance XP male sling
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ricarda Bauer, MD
role: Principal Investigator
affiliation: Ludwig-Maximilians Universität (LMU)
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 