<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/NCT03821142</url>
  </required_header>
  <id_info>
    <org_study_id>CaS_Pro</org_study_id>
    <nct_id>NCT03821142</nct_id>
  </id_info>
  <brief_title>Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair</brief_title>
  <acronym>CASPO</acronym>
  <official_title>Prospective, Multicenter, 60 Months, Single Arm Cohort Study to Evaluate the Efficacy and Safety of the Ultra-Light-Weight Mesh CAlistar S in Transvaginal Pelvic Organ Prolapse Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Promedon</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Promedon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal&#xD;
      pelvic organ prolapse repair in women with anterior POP with or without apical vaginal&#xD;
      involvement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for&#xD;
      transvaginal reestablishment and reinforcement of the physiologic anatomy of the female&#xD;
      pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical&#xD;
      vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ&#xD;
      prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse).&#xD;
&#xD;
      The treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue&#xD;
      anchoring system (TAS) anchors for fixation to the sacrospinous ligament. The product is&#xD;
      approved in accordance with the CE Directive 93/42/EEC.&#xD;
&#xD;
      The utilization of synthetic implants in POP repair became increasingly popular in the last&#xD;
      decade. The cumulative success rate of synthetic implants in anterior compartment repair is&#xD;
      as high as up to 93%.However, meshes have been recently scrutinized due to high adverse event&#xD;
      reporting after unreflected utilization of meshes which raised concerns of patients safety;&#xD;
      furthermore taking into account the complexity of adverse event mesh management. This led to&#xD;
      a vanishing of various meshes in transvaginal POP repair. Nevertheless, the further&#xD;
      development of light weight meshes, the experience of the surgeon and the assessment and&#xD;
      patients selection are well known factors reducing the rate of adverse events significantly.&#xD;
&#xD;
      Therefore, in the current trial the efficacy and safety of calistar S in a highly selected&#xD;
      patient population will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 10, 2021</start_date>
  <completion_date type="Anticipated">March 10, 2028</completion_date>
  <primary_completion_date type="Anticipated">March 10, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Calistar S Single Incision POP System</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Blinded POP-Q Examination: The POP-Q examination will be performed by a physician different to the corresponding surgeon</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients with Cure of pelvic organ prolapse</measure>
    <time_frame>24 months</time_frame>
    <description>Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up</measure>
    <time_frame>Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>Differences between Baseline and Follow-Up result of the questionnaire of each patient regarding Quality of life and the correlating domains will be evaluated. P-QoL, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the lower quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up</measure>
    <time_frame>Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>Differences between Baseline and Follow-Up result of each patient regarding Sexual life and the correlating domains will be evaluated. PISQ-IR, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the higher the impact on sexual life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up</measure>
    <time_frame>Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>Differences of pain-evaluation between Baseline and Follow-Up of each patient will be evaluated. Wong Baker Pain Scale, Score: 0 - 10, The higher the score, the higher the pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement</measure>
    <time_frame>6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>Evaluation of the improvement of POP after the operation assed by the Patient Global Impression of Improvement of each patient. PGI-I, Score: 7 Likert scale from: very much better to very much worse,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient subjective evaluation of POP severity according the Global Impression of Severity</measure>
    <time_frame>Baseline</time_frame>
    <description>Evaluation of severity categorization by assing the Patient Global Impression of Severity of each patient at Baseline. Score. 4 Likert scale, from no impact to very much impact. A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up</measure>
    <time_frame>Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>Evaluation of Quality of life assessed by the EQ-5L-5D and evaluation of differences between Baseline and Follow-Up of each patient regarding health related Quality of life. Two scores: a) 5 Likert scale from no problems to extreme problems. b) self administered quality of life in scale 0 - 100, the higher the score the better the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomical success according the number of patients with anterior vaginal wall at or above the hymen and no decent of apical vaginal wall at or greater than half of the total vanilla lengths</measure>
    <time_frame>6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>Anatomical success defined by the number of patients with the anterior vaginal wall at or above the hymen (Aa and Ba ≤ 0 ) and separately no decent of apical vaginal wall at or greater than half of the total vaginal lengths (C &lt; -½ TVL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with necessity of repeated surgery due to recurrent anterior or apical Number of patients with Repeat surgery due to symptomatic recurrence of anterior or apical POP</measure>
    <time_frame>6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>Number of patients with necessity of repeated surgery due to recurrent anterior or apical POP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Calistar S according the number of adverse events</measure>
    <time_frame>intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits</time_frame>
    <description>Safety of Calistar S according the assessment of total amount of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exposure and anatomical-failure free survival</measure>
    <time_frame>12, 24, 36, 48, 60 months</time_frame>
    <description>Estimation of exposure- and anatomical-failure free survival according Kaplan meier</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with further surgery for stress urinary incontinence</measure>
    <time_frame>6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>To assess the number of patients with further surgery for stress urinary incontinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up</measure>
    <time_frame>Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>The international Consultation of Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) is a validated questionnaire to asses urinary incontinence. Score 0-21, overall score with greater values indicating increased symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up</measure>
    <time_frame>Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months</time_frame>
    <description>The International Consultation of Incontinence Questionnaire - Overacitve bladder (ICIQ-OAB) is a validated questionnaire.. 0-16 overall score with greater values indicating increased symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cure in short-, mid-, and longterm follow-up</measure>
    <time_frame>6 weeks and 6, 12, 36, 48, 60 months</time_frame>
    <description>Number of patients accomplishing the composite outcome at remaining follow-up times</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Calistar S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm cohort trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transvaginal mesh for anterior pelvic organ prolapse repair</intervention_name>
    <description>synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population</description>
    <arm_group_label>Calistar S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria Non-fertile women &gt; 18 years1 2. Symtomatic anterior prolapse with or&#xD;
        without apical vaginal wall involvement according POP-Q score ≥ 2. (Corresponding to Aa, Ba&#xD;
        ≥ -1 and where applicable C ≥ -1/2 TVL ).&#xD;
&#xD;
        3. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.&#xD;
&#xD;
        4. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Fertile women&#xD;
&#xD;
          2. Patients with active or latent infection of the vagina, cervix or uterus&#xD;
&#xD;
          3. Patients with previous or current vaginal, cervical or uterine cancer&#xD;
&#xD;
          4. Previous, current or planned pelvic radiation therapy&#xD;
&#xD;
          5. Known allergy to polypropylene&#xD;
&#xD;
        7. Subject is unable or unwilling to complete questionnaires (either self-administered,&#xD;
        assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gert Naumann, PD Dr.habil.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helios Hospital Erfurt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ralf Tunn, Prof.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Hedwig Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dirk Watermann, Prof.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Evangelic Diakonie Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Birgit Henne, Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Elisabeth-Hospital Leipzig</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christl Reisenauer, Prof.Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tübingen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Fünfgeld, Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Tettnang</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philipp Schelhorn</last_name>
    <phone>00498031900400</phone>
    <email>trials.de@promedon.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lorena Lopez, Ph.D, Bioeng</last_name>
    <phone>005493514502100</phone>
    <email>lorena.lopez@promedon.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Helios Hospital Erfurt, Department of gynaecology</name>
      <address>
        <city>Erfurt</city>
        <state>Thüringen</state>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gert Naumann, PD Dr.habil.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Hedwig Hospital</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ralf Tunn, Prof.Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Evangelic Diakonie Hospital</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dirk Watermann, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Elisabeth-Hospital Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Birgit Henne, Dr.med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Tettnang</name>
      <address>
        <city>Tettnang</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Fünfgeld, Dr.med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Tübingen</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christl Reisenauer, Prof.Dr.med.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <reference>
    <citation>Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.</citation>
    <PMID>9083302</PMID>
  </reference>
  <reference>
    <citation>Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.</citation>
    <PMID>24807341</PMID>
  </reference>
  <reference>
    <citation>Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.</citation>
    <PMID>24463674</PMID>
  </reference>
  <reference>
    <citation>Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819.</citation>
    <PMID>12066091</PMID>
  </reference>
  <reference>
    <citation>Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study. Br J Obstet Gynaecol. 1997 May;104(5):579-85. doi: 10.1111/j.1471-0528.1997.tb11536.x.</citation>
    <PMID>9166201</PMID>
  </reference>
  <reference>
    <citation>Risk factors for genital prolapse in non-hysterectomized women around menopause. Results from a large cross-sectional study in menopausal clinics in Italy. Progetto Menopausa Italia Study Group. Eur J Obstet Gynecol Reprod Biol. 2000 Dec;93(2):135-40.</citation>
    <PMID>11074133</PMID>
  </reference>
  <reference>
    <citation>Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.</citation>
    <PMID>11744914</PMID>
  </reference>
  <reference>
    <citation>Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.</citation>
    <PMID>16021067</PMID>
  </reference>
  <reference>
    <citation>Lenz F, Stammer H, Brocker K, Rak M, Scherg H, Sohn C. Validation of a German version of the P-QOL Questionnaire. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):641-9. doi: 10.1007/s00192-009-0809-x. Epub 2009 Feb 13.</citation>
    <PMID>19214361</PMID>
  </reference>
  <reference>
    <citation>Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. doi: 10.1007/s00192-004-1225-x. Epub 2004 Oct 21.</citation>
    <PMID>15875234</PMID>
  </reference>
  <reference>
    <citation>Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2004 May-Jun;15(3):219.</citation>
    <PMID>12955337</PMID>
  </reference>
  <reference>
    <citation>Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. doi: 10.1016/s0304-3959(00)00375-4. No abstract available.</citation>
    <PMID>11291631</PMID>
  </reference>
  <reference>
    <citation>Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.</citation>
    <PMID>8694033</PMID>
  </reference>
  <reference>
    <citation>Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.</citation>
    <PMID>17182981</PMID>
  </reference>
  <reference>
    <citation>Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.</citation>
    <PMID>15273542</PMID>
  </reference>
  <reference>
    <citation>Practice Bulletin No. 176: Pelvic Organ Prolapse. Obstet Gynecol. 2017 Apr;129(4):e56-e72. doi: 10.1097/AOG.0000000000002016.</citation>
    <PMID>28333818</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgical mesh</keyword>
  <keyword>surgery</keyword>
  <keyword>Therapy</keyword>
  <keyword>pelvic floor disorders</keyword>
  <keyword>cystocele</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821142
org study id: CaS_Pro
nct id: NCT03821142
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal
      pelvic organ prolapse repair in women with anterior POP with or without apical vaginal
      involvement
Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for
      transvaginal reestablishment and reinforcement of the physiologic anatomy of the female
      pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical
      vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ
      prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse).

      The treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue
      anchoring system (TAS) anchors for fixation to the sacrospinous ligament. The product is
      approved in accordance with the CE Directive 93/42/EEC.

      The utilization of synthetic implants in POP repair became increasingly popular in the last
      decade. The cumulative success rate of synthetic implants in anterior compartment repair is
      as high as up to 93%.However, meshes have been recently scrutinized due to high adverse event
      reporting after unreflected utilization of meshes which raised concerns of patients safety;
      furthermore taking into account the complexity of adverse event mesh management. This led to
      a vanishing of various meshes in transvaginal POP repair. Nevertheless, the further
      development of light weight meshes, the experience of the surgeon and the assessment and
      patients selection are well known factors reducing the rate of adverse events significantly.

      Therefore, in the current trial the efficacy and safety of calistar S in a highly selected
      patient population will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Calistar S Single Incision POP System
primary purpose: Treatment
masking: None (Open Label)
masking description: Blinded POP-Q Examination: The POP-Q examination will be performed by a physician different to the corresponding surgeon
measure: Number of Patients with Cure of pelvic organ prolapse
time frame: 24 months
description: Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components
measure: Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up
time frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
description: Differences between Baseline and Follow-Up result of the questionnaire of each patient regarding Quality of life and the correlating domains will be evaluated. P-QoL, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the lower quality of life.
measure: Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up
time frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
description: Differences between Baseline and Follow-Up result of each patient regarding Sexual life and the correlating domains will be evaluated. PISQ-IR, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the higher the impact on sexual life.
measure: Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up
time frame: Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months
description: Differences of pain-evaluation between Baseline and Follow-Up of each patient will be evaluated. Wong Baker Pain Scale, Score: 0 - 10, The higher the score, the higher the pain.
measure: Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement
time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
description: Evaluation of the improvement of POP after the operation assed by the Patient Global Impression of Improvement of each patient. PGI-I, Score: 7 Likert scale from: very much better to very much worse,
measure: Patient subjective evaluation of POP severity according the Global Impression of Severity
time frame: Baseline
description: Evaluation of severity categorization by assing the Patient Global Impression of Severity of each patient at Baseline. Score. 4 Likert scale, from no impact to very much impact. A
measure: Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up
time frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
description: Evaluation of Quality of life assessed by the EQ-5L-5D and evaluation of differences between Baseline and Follow-Up of each patient regarding health related Quality of life. Two scores: a) 5 Likert scale from no problems to extreme problems. b) self administered quality of life in scale 0 - 100, the higher the score the better the quality of life.
measure: Anatomical success according the number of patients with anterior vaginal wall at or above the hymen and no decent of apical vaginal wall at or greater than half of the total vanilla lengths
time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
description: Anatomical success defined by the number of patients with the anterior vaginal wall at or above the hymen (Aa and Ba ≤ 0 ) and separately no decent of apical vaginal wall at or greater than half of the total vaginal lengths (C < -½ TVL).
measure: Number of patients with necessity of repeated surgery due to recurrent anterior or apical Number of patients with Repeat surgery due to symptomatic recurrence of anterior or apical POP
time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
description: Number of patients with necessity of repeated surgery due to recurrent anterior or apical POP.
measure: Safety of Calistar S according the number of adverse events
time frame: intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits
description: Safety of Calistar S according the assessment of total amount of adverse events
measure: Exposure and anatomical-failure free survival
time frame: 12, 24, 36, 48, 60 months
description: Estimation of exposure- and anatomical-failure free survival according Kaplan meier
measure: Number of patients with further surgery for stress urinary incontinence
time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
description: To assess the number of patients with further surgery for stress urinary incontinence.
measure: Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up
time frame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
description: The international Consultation of Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) is a validated questionnaire to asses urinary incontinence. Score 0-21, overall score with greater values indicating increased symptom severity
measure: Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up
time frame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
description: The International Consultation of Incontinence Questionnaire - Overacitve bladder (ICIQ-OAB) is a validated questionnaire.. 0-16 overall score with greater values indicating increased symptom severity
measure: Cure in short-, mid-, and longterm follow-up
time frame: 6 weeks and 6, 12, 36, 48, 60 months
description: Number of patients accomplishing the composite outcome at remaining follow-up times
arm group label: Calistar S
arm group type: Experimental
description: Single arm cohort trial
intervention type: Device
intervention name: Transvaginal mesh for anterior pelvic organ prolapse repair
description: synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population
arm group label: Calistar S
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gert Naumann, PD Dr.habil.
role: Principal Investigator
affiliation: Helios Hospital Erfurt
last name: Ralf Tunn, Prof.Dr.
role: Principal Investigator
affiliation: St. Hedwig Hospital
last name: Dirk Watermann, Prof.Dr.
role: Principal Investigator
affiliation: Evangelic Diakonie Hospital
last name: Birgit Henne, Dr.med.
role: Principal Investigator
affiliation: St. Elisabeth-Hospital Leipzig
last name: Christl Reisenauer, Prof.Dr.med.
role: Principal Investigator
affiliation: University Hospital Tübingen
last name: Christian Fünfgeld, Dr.med.
role: Principal Investigator
affiliation: Hospital Tettnang
last name: Philipp Schelhorn
phone: 00498031900400
email: trials.de@promedon.com
last name: Lorena Lopez, Ph.D, Bioeng
phone: 005493514502100
email: lorena.lopez@promedon.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
country: Netherlands
citation: Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
PMID: 9083302
citation: Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
PMID: 24807341
citation: Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
PMID: 24463674
citation: Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819.
PMID: 12066091
citation: Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study. Br J Obstet Gynaecol. 1997 May;104(5):579-85. doi: 10.1111/j.1471-0528.1997.tb11536.x.
PMID: 9166201
citation: Risk factors for genital prolapse in non-hysterectomized women around menopause. Results from a large cross-sectional study in menopausal clinics in Italy. Progetto Menopausa Italia Study Group. Eur J Obstet Gynecol Reprod Biol. 2000 Dec;93(2):135-40.
PMID: 11074133
citation: Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
PMID: 11744914
citation: Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
PMID: 16021067
citation: Lenz F, Stammer H, Brocker K, Rak M, Scherg H, Sohn C. Validation of a German version of the P-QOL Questionnaire. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):641-9. doi: 10.1007/s00192-009-0809-x. Epub 2009 Feb 13.
PMID: 19214361
citation: Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. doi: 10.1007/s00192-004-1225-x. Epub 2004 Oct 21.
PMID: 15875234
citation: Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2004 May-Jun;15(3):219.
PMID: 12955337
citation: Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. doi: 10.1016/s0304-3959(00)00375-4. No abstract available.
PMID: 11291631
citation: Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
PMID: 8694033
citation: Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.
PMID: 17182981
citation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PMID: 15273542
citation: Practice Bulletin No. 176: Pelvic Organ Prolapse. Obstet Gynecol. 2017 Apr;129(4):e56-e72. doi: 10.1097/AOG.0000000000002016.
PMID: 28333818
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No