xml: <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/NCT06000215</url>
    </required_header>
    <id_info>
      <org_study_id>Dnr: 2018/1523-31</org_study_id>
      <nct_id>NCT06000215</nct_id>
    </id_info>
    <brief_title>Credibility of Ultrasound Detection of Female Genital Prolapse Mesh</brief_title>
    <acronym>KIDS</acronym>
    <official_title>Credibility of Ultrasound Detection of Female Genital Prolapse Mesh</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karolinska Institutet</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to investigate the credibility of ultrasound in detection of&#xD;
        synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound&#xD;
        examiner experience and the standard method of examination may affect the detection of&#xD;
        synthetic polypropylene vaginal implants by ultrasound.&#xD;
  &#xD;
        The primary hypothesis is if 90% of prolapse mesh could be detected by the ultrasound&#xD;
        examiners who are blinded to the previous prolapse surgery, the ultrasound is credible for&#xD;
        prolapse mesh detection.&#xD;
  &#xD;
        The secondary hypothesis is if the ultrasound detection is not significantly different&#xD;
        between the ultrasound examiners, the method of ultrasound examination is mandatory to&#xD;
        acheive credible ultrasound detection of the prolapse mesh.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pelvic organ prolapse (POP) is a common condition in post-delivery and post-reproductive aged&#xD;
        women (1). The lifetime risk of undergoing a single operation for prolapse or incontinence by&#xD;
        age 80 is 11% (2). POP is mainly classified into three compartments: anterior, middle&#xD;
        (apical) or posterior (1). Apical defects include descensus uteri or vaginal vault prolapse&#xD;
        after previous hysterectomy. Traditional Surgical repairs of POP using native connective&#xD;
        tissues are commonly used but the risk for POP recurrence is high if apical prolapse is&#xD;
        present (ca 60%) (1). Thus, the development of different mesh types using different&#xD;
        approaches to support the vaginal apex (uterus or vaginal top) is highly growing. Surgery may&#xD;
        be done by transvaginal mesh (TVM) or robotic-assisted sacroclpopexy (3). Increasing evidence&#xD;
        show effectivity of both methods and improved HR-QoL after surgery (4, 5, 6, 7, 8, 9).&#xD;
        However, PFD including urinary incontinence, urinary bladder emptying disorders and prolapse&#xD;
        recurrence may be postoperative conditions (1, 2).&#xD;
  &#xD;
        Growing needs worldwide is to improve diagnostic methods such as ultrasonography (US). This&#xD;
        may improve the clinical knowledge to be further used for management of pelvic floor&#xD;
        disorders (PFD). US is a cheap and safe method as compared to magnetic resonance (MR) or&#xD;
        computed tomography (CT) (10). Thus, if using US to provide clinical examination instead of&#xD;
        MR and CT the health care cost may be reduced. Indeed, US can provide imaging in some cross&#xD;
        sections giving same imaging results of MR (10).&#xD;
  &#xD;
        Some studies have been investigating the use of endo-vaginal, trans-perineal/introital and&#xD;
        trans-labial US techniques in detection of implants with more focus on TVT-surgery&#xD;
        (Tension-free vaginal tape) for urinary incontinence (UI) and to some extent detection of&#xD;
        prolapse mesh (11). However, sensitivity of depiction has been reported to 92% at rest and&#xD;
        72% on physical examination when using endovaginal US examination (11). Also, the depiction&#xD;
        is dependent on the US expertise since no standardization has been achieved. Furthermore, the&#xD;
        presence of scar tissues following previous POP or UI surgery in the pelvic floor region has&#xD;
        been described as an interrupting factor for prediction (10).&#xD;
  &#xD;
        Thus, development of a standardized US prediction of implants in order to elucidate&#xD;
        anatomical and functional information in the pelvic floor when POP mesh is implanted may be&#xD;
        useful in management of PFD. It is to investigate the sensitivity and reproducibility of this&#xD;
        US model of examination.&#xD;
  &#xD;
        The purpose of the present study is to investigate the credibility of the US detection of&#xD;
        prolapse mesh implants when a standardized method of US examination is performed.&#xD;
  &#xD;
        Methodology of the present study Perineal/introital and vaginal ultrasound examination is&#xD;
        done using a standard protocol by two different US examiners of four groups of patients&#xD;
        previously received prolapse surgery. Each examiner is to be entered from the pre-examination&#xD;
        room, do all requested examinations in one time, and leave from the examination room to be&#xD;
        followed by the next examiner without meeting each other. Thus, the ultrasound examiners are&#xD;
        to be blinded to each other and to the previous prolapse surgery. A controller is appointed&#xD;
        to introduce each examiner from the pre-examination room, record the time of each examination&#xD;
        and collect the results of examinations. The statistician is also to be blinded to the group&#xD;
        of examination.&#xD;
  &#xD;
        References&#xD;
  &#xD;
          1. Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013; 24(11):1815-33.&#xD;
  &#xD;
          2. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically&#xD;
             managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997&#xD;
             Apr;89(4):501-6.&#xD;
  &#xD;
          3. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in&#xD;
             women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014.&#xD;
  &#xD;
          4. Oliver JL, Kim JH. Robotic Sacrocolpopexy-Is It the Treatment of Choice for Advanced&#xD;
             Apical Pelvic Organ Prolapse? Curr Urol Rep. 2017 Sep;18(9):66-74.&#xD;
  &#xD;
          5. Rahkola-Soisalo P, Mikkola TS, Altman D, Falconer C; for Nordic TVM Group. Pelvic Organ&#xD;
             Prolapse Repair Using the Uphold Vaginal Support System: 5-Year Follow-up. Female Pelvic&#xD;
             Med Reconstr Surg. 2017 Dec 11. Fortcoming 2018.&#xD;
  &#xD;
          6. Gutman RE, Rardin CR, Sokol ER, Matthews C, Park AJ, Iglesia CB, st al. Vaginal and&#xD;
             laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study. Am J&#xD;
             Obstet Gynecol. 2017. Jan;216(1):38.e1-38.e11.&#xD;
  &#xD;
          7. Lua LL, Vicente ED, Pathak P, Lybbert D, Dandolu V. Comparative analysis of overall cost&#xD;
             and rate of healthcare utilization among apical prolapse procedures. Int Urogynecol J.&#xD;
             2017 Oct;28(10):1481-8.&#xD;
  &#xD;
          8. Rahkola-Soisalo P, Altman D, Falconer C, Morcos E, Rudnicki M, Mikkola TS. Quality of&#xD;
             life after Uphold™ Vaginal Support System surgery for apical pelvic organ prolapse-A&#xD;
             prospective multicenter study. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:86-90.&#xD;
             doi: 10.1016/j.ejogrb.2016.11.011. Epub 2016 Nov 14.&#xD;
  &#xD;
          9. Altman D, Geale K, Falconer C, Morcos E. A generic health-related quality of life&#xD;
             instrument for assessing pelvic organ prolapse surgery: correlation with&#xD;
             condition-specific outcome measures. Int Urogynecol J. 2018 Mar 6. doi:&#xD;
             10.1007/s00192-018-3587-5.&#xD;
  &#xD;
         10. Khatri G, Carmel ME, Bailey AA, Foreman MR, Brewington CC, Zimmern PE, Pedrosa I.&#xD;
             Postoperative Imaging after Surgical Repair for Pelvic Floor Dysfunction. Radiographics.&#xD;
             2016 Jul-Aug;36(4):1233-56.&#xD;
  &#xD;
         11. Manonai J, Rostaminia G, Denson L, Shobeiri SA. Clinical and ultrasonographic study of&#xD;
             patients presenting with transvaginal mesh complications. Neurourol Urodyn. 2016&#xD;
             Mar;35(3):407-11. doi: 10.1002/nau.22725. Epub 2015 Jan 25.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 21, 2018</start_date>
    <completion_date type="Actual">December 21, 2018</completion_date>
    <primary_completion_date type="Actual">December 21, 2018</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Detection of which mesh without being informed of previous surgery</measure>
      <time_frame>Maximum of 10 minutes for all examination</time_frame>
      <description>Without being informed of previous surgery, examiners are to separately diagnose which mesh vs no mesh</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Precision of mesh detection</measure>
      <time_frame>Maximum of 10 minutes for all examination</time_frame>
      <description>Being informed of which surgery, examiners are to separately measure the midsagittal lengths of the mesh.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">120</enrollment>
    <condition>Ultrasound Therapy; Complications</condition>
    <arm_group>
      <arm_group_label>Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)</arm_group_label>
      <description>Patients previousely received the Uphold™ Lite for the surgical management of apical and/or anterior vaginal mesh prolapse.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pinnacle posterior Vaginal mesh - Boston Scientific</arm_group_label>
      <description>Patients previousely received the Pinnacle posterior Vaginal mesh for the surgical management of posterior and/or apical vaginal mesh prolapse.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)</arm_group_label>
      <description>Patients previousely received the Artisyn® Y-Shaped Mesh via robotic-assisted approach Patients previousely received th Artisyn® Y-Shaped Mesh via robotic-assisted approach for the surgical management of apical prolapse..</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Native tissue repair</arm_group_label>
      <description>Patients previousely received native tissue repair for the surgical management of prolapse.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.</intervention_name>
      <description>Each examiner to answer:&#xD;
  Is there a mesh or not: Yes or No&#xD;
  If Yes:&#xD;
  Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh&#xD;
  What is the length of the mesh in a single midsagittal view image&#xD;
  Examination record time is to be registered.</description>
      <arm_group_label>Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)</arm_group_label>
      <arm_group_label>Native tissue repair</arm_group_label>
      <arm_group_label>Pinnacle posterior Vaginal mesh - Boston Scientific</arm_group_label>
      <arm_group_label>Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)</arm_group_label>
      <other_name>Vaginal ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.</intervention_name>
      <description>Each examiner to answer:&#xD;
  Is there a mesh or not: Yes or No&#xD;
  If Yes:&#xD;
  Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh&#xD;
  What is the length of the mesh in a single midsagittal view image&#xD;
  Examination record time is to be registered.</description>
      <arm_group_label>Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)</arm_group_label>
      <arm_group_label>Native tissue repair</arm_group_label>
      <arm_group_label>Pinnacle posterior Vaginal mesh - Boston Scientific</arm_group_label>
      <arm_group_label>Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)</arm_group_label>
      <other_name>Vaginal ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients operated by one of the procedures:&#xD;
  &#xD;
            1. Anterior TVM (Uphold™ Lite Vaginal mesh - Boston Scientific.&#xD;
  &#xD;
            2. Posterior POP mesh (Pinnacle posterior - Boston Scientific or equal)&#xD;
  &#xD;
            3. Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn® Y-Shaped Mesh - Ethicon or&#xD;
               equal).&#xD;
  &#xD;
            4. patients received anterior and/or posterior colporraphy i.e. native tissue repair i.e.&#xD;
               no synthetic materials used (control group).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients operated by one of the procedures mentioned 1. Anterior TVM (Uphold™ Lite&#xD;
               Vaginal mesh - Boston Scientific. 2. Posterior POP mesh (Pinnacle posterior - Boston&#xD;
               Scientific or equal) 3. Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn®&#xD;
               Y-Shaped Mesh - Ethicon or equal). and 4. patients received anterior and/or posterior&#xD;
               colporraphy i.e. native tissue repair i.e. no synthetic materials used (control&#xD;
               group).&#xD;
  &#xD;
            -  All patients should have suffered prolapse symptoms before surgery such as pelvic&#xD;
               heaviness and/or vaginal bulging, extra.&#xD;
  &#xD;
            -  Being able to make an informed consent on participation&#xD;
  &#xD;
            -  Physically and cognitively capable of participating in the examination&#xD;
  &#xD;
            -  No exclusion criteria fulfilled&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients operated by different procedures t.ex. two different mesh types&#xD;
  &#xD;
            -  Advanced procedure in the pelvic floor such as current pelvic organ cancer (regardless&#xD;
               of treatment)&#xD;
  &#xD;
            -  Other clinically relevant pelvic disorders for which surgery with other materials (not&#xD;
               polypropylene mesh) was previously provided.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Patients are only females previousely received surgery for female genital prolapse.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Edward Morcos, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Karolinska Institutet - Danderyds Sjukhus (KIDS)</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital</name>
        <address>
          <city>Stockholm</city>
          <zip>18288</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
      <investigator_full_name>Edward Morcos</investigator_full_name>
      <investigator_title>MD, PhD. Senior Consultant.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prolapse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD is only available to the principal investigator.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000215
  org study id: Dnr: 2018/1523-31
  nct id: NCT06000215
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The aim of the study is to investigate the credibility of ultrasound in detection of
        synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound
        examiner experience and the standard method of examination may affect the detection of
        synthetic polypropylene vaginal implants by ultrasound.
  
        The primary hypothesis is if 90% of prolapse mesh could be detected by the ultrasound
        examiners who are blinded to the previous prolapse surgery, the ultrasound is credible for
        prolapse mesh detection.
  
        The secondary hypothesis is if the ultrasound detection is not significantly different
        between the ultrasound examiners, the method of ultrasound examination is mandatory to
        acheive credible ultrasound detection of the prolapse mesh.
  Pelvic organ prolapse (POP) is a common condition in post-delivery and post-reproductive aged
        women (1). The lifetime risk of undergoing a single operation for prolapse or incontinence by
        age 80 is 11% (2). POP is mainly classified into three compartments: anterior, middle
        (apical) or posterior (1). Apical defects include descensus uteri or vaginal vault prolapse
        after previous hysterectomy. Traditional Surgical repairs of POP using native connective
        tissues are commonly used but the risk for POP recurrence is high if apical prolapse is
        present (ca 60%) (1). Thus, the development of different mesh types using different
        approaches to support the vaginal apex (uterus or vaginal top) is highly growing. Surgery may
        be done by transvaginal mesh (TVM) or robotic-assisted sacroclpopexy (3). Increasing evidence
        show effectivity of both methods and improved HR-QoL after surgery (4, 5, 6, 7, 8, 9).
        However, PFD including urinary incontinence, urinary bladder emptying disorders and prolapse
        recurrence may be postoperative conditions (1, 2).
  
        Growing needs worldwide is to improve diagnostic methods such as ultrasonography (US). This
        may improve the clinical knowledge to be further used for management of pelvic floor
        disorders (PFD). US is a cheap and safe method as compared to magnetic resonance (MR) or
        computed tomography (CT) (10). Thus, if using US to provide clinical examination instead of
        MR and CT the health care cost may be reduced. Indeed, US can provide imaging in some cross
        sections giving same imaging results of MR (10).
  
        Some studies have been investigating the use of endo-vaginal, trans-perineal/introital and
        trans-labial US techniques in detection of implants with more focus on TVT-surgery
        (Tension-free vaginal tape) for urinary incontinence (UI) and to some extent detection of
        prolapse mesh (11). However, sensitivity of depiction has been reported to 92% at rest and
        72% on physical examination when using endovaginal US examination (11). Also, the depiction
        is dependent on the US expertise since no standardization has been achieved. Furthermore, the
        presence of scar tissues following previous POP or UI surgery in the pelvic floor region has
        been described as an interrupting factor for prediction (10).
  
        Thus, development of a standardized US prediction of implants in order to elucidate
        anatomical and functional information in the pelvic floor when POP mesh is implanted may be
        useful in management of PFD. It is to investigate the sensitivity and reproducibility of this
        US model of examination.
  
        The purpose of the present study is to investigate the credibility of the US detection of
        prolapse mesh implants when a standardized method of US examination is performed.
  
        Methodology of the present study Perineal/introital and vaginal ultrasound examination is
        done using a standard protocol by two different US examiners of four groups of patients
        previously received prolapse surgery. Each examiner is to be entered from the pre-examination
        room, do all requested examinations in one time, and leave from the examination room to be
        followed by the next examiner without meeting each other. Thus, the ultrasound examiners are
        to be blinded to each other and to the previous prolapse surgery. A controller is appointed
        to introduce each examiner from the pre-examination room, record the time of each examination
        and collect the results of examinations. The statistician is also to be blinded to the group
        of examination.
  
        References
  
          1. Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013; 24(11):1815-33.
  
          2. 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.
  
          3. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in
             women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014.
  
          4. Oliver JL, Kim JH. Robotic Sacrocolpopexy-Is It the Treatment of Choice for Advanced
             Apical Pelvic Organ Prolapse? Curr Urol Rep. 2017 Sep;18(9):66-74.
  
          5. Rahkola-Soisalo P, Mikkola TS, Altman D, Falconer C; for Nordic TVM Group. Pelvic Organ
             Prolapse Repair Using the Uphold Vaginal Support System: 5-Year Follow-up. Female Pelvic
             Med Reconstr Surg. 2017 Dec 11. Fortcoming 2018.
  
          6. Gutman RE, Rardin CR, Sokol ER, Matthews C, Park AJ, Iglesia CB, st al. Vaginal and
             laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study. Am J
             Obstet Gynecol. 2017. Jan;216(1):38.e1-38.e11.
  
          7. Lua LL, Vicente ED, Pathak P, Lybbert D, Dandolu V. Comparative analysis of overall cost
             and rate of healthcare utilization among apical prolapse procedures. Int Urogynecol J.
             2017 Oct;28(10):1481-8.
  
          8. Rahkola-Soisalo P, Altman D, Falconer C, Morcos E, Rudnicki M, Mikkola TS. Quality of
             life after Uphold™ Vaginal Support System surgery for apical pelvic organ prolapse-A
             prospective multicenter study. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:86-90.
             doi: 10.1016/j.ejogrb.2016.11.011. Epub 2016 Nov 14.
  
          9. Altman D, Geale K, Falconer C, Morcos E. A generic health-related quality of life
             instrument for assessing pelvic organ prolapse surgery: correlation with
             condition-specific outcome measures. Int Urogynecol J. 2018 Mar 6. doi:
             10.1007/s00192-018-3587-5.
  
         10. Khatri G, Carmel ME, Bailey AA, Foreman MR, Brewington CC, Zimmern PE, Pedrosa I.
             Postoperative Imaging after Surgical Repair for Pelvic Floor Dysfunction. Radiographics.
             2016 Jul-Aug;36(4):1233-56.
  
         11. Manonai J, Rostaminia G, Denson L, Shobeiri SA. Clinical and ultrasonographic study of
             patients presenting with transvaginal mesh complications. Neurourol Urodyn. 2016
             Mar;35(3):407-11. doi: 10.1002/nau.22725. Epub 2015 Jan 25.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Detection of which mesh without being informed of previous surgery
  time frame: Maximum of 10 minutes for all examination
  description: Without being informed of previous surgery, examiners are to separately diagnose which mesh vs no mesh
  measure: Precision of mesh detection
  time frame: Maximum of 10 minutes for all examination
  description: Being informed of which surgery, examiners are to separately measure the midsagittal lengths of the mesh.
  arm group label: Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)
  description: Patients previousely received the Uphold™ Lite for the surgical management of apical and/or anterior vaginal mesh prolapse.
  arm group label: Pinnacle posterior Vaginal mesh - Boston Scientific
  description: Patients previousely received the Pinnacle posterior Vaginal mesh for the surgical management of posterior and/or apical vaginal mesh prolapse.
  arm group label: Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)
  description: Patients previousely received the Artisyn® Y-Shaped Mesh via robotic-assisted approach Patients previousely received th Artisyn® Y-Shaped Mesh via robotic-assisted approach for the surgical management of apical prolapse..
  arm group label: Native tissue repair
  description: Patients previousely received native tissue repair for the surgical management of prolapse.
  intervention type: Diagnostic Test
  intervention name: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.
  description: Each examiner to answer:
  Is there a mesh or not: Yes or No
  If Yes:
  Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh
  What is the length of the mesh in a single midsagittal view image
  Examination record time is to be registered.
  arm group label: Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)
  arm group label: Native tissue repair
  arm group label: Pinnacle posterior Vaginal mesh - Boston Scientific
  arm group label: Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)
  other name: Vaginal ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery
  intervention type: Diagnostic Test
  intervention name: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.
  description: Each examiner to answer:
  Is there a mesh or not: Yes or No
  If Yes:
  Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh
  What is the length of the mesh in a single midsagittal view image
  Examination record time is to be registered.
  arm group label: Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)
  arm group label: Native tissue repair
  arm group label: Pinnacle posterior Vaginal mesh - Boston Scientific
  arm group label: Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)
  other name: Vaginal ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Patients are only females previousely received surgery for female genital prolapse.
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Edward Morcos, MD, PhD
  role: Principal Investigator
  affiliation: Karolinska Institutet - Danderyds Sjukhus (KIDS)
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Karolinska Institutet
  investigator full name: Edward Morcos
  investigator title: MD, PhD. Senior Consultant.
  mesh term: Prolapse
  sharing ipd: No
  ipd description: IPD is only available to the principal investigator.