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/NCT05964881</url>
    </required_header>
    <id_info>
      <org_study_id>2079</org_study_id>
      <nct_id>NCT05964881</nct_id>
    </id_info>
    <brief_title>PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy</brief_title>
    <official_title>PDS (Polydiaxonene Suture) Versus Prolene (Polypropylene Suture) as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Vienna</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Vienna</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of&#xD;
        women develop in the course of their lives. There are many different options for surgical&#xD;
        care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP).&#xD;
        This technique has been increasingly used in recent years. However, there is still no data on&#xD;
        whether the fixation sutures should be performed with absorbable or non-absorbable threads.&#xD;
        Internationally, both types of threads are routinely used and both types of threads are&#xD;
        described in publications. So far, there is no comparative data on the effectiveness and&#xD;
        subjective results. The aim of this study is to compare subjective symptom improvement&#xD;
        Materials &amp; Methods: This is a randomized, single-center superiority study. The sacrospinal&#xD;
        fixation is performed according to a standardized method and two different types of threads&#xD;
        (absorbable PDS sutures vs. non-absorbable Prolene sutures) are used for the fixation suture.&#xD;
        Patients are randomized to either the absorbable PDS sutures group or the non-absorbable&#xD;
        Prolene sutures group. The primary outcome of interest is the subjective symptom improvement&#xD;
        12 months after surgery (evaluated using the German version of the pelvic floor&#xD;
        questionnaire). Secondary outcome variables are anatomical outcomes, condition-specific&#xD;
        quality of life, and adverse events. 52 patients will be included in the study.&#xD;
  &#xD;
        The results of the study will be published in peer-reviewed journals and the results will be&#xD;
        presented at scientific meetings.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>German pelvic floor questionnaire (subjective symptom improvement)</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>subjective symptom improvement 12 months after surgery evaluated using the German version of the pelvic floor questionnaire, which consist of 4 domains and a total of 42 questions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>anatomical outcomes - POP-Q measurement</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>anatomical outcomes 12 months after surgery evaluated through POP-Q-system (standardised POP-Q scale ranging from 0-4; the higher the number the worse the prolapse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>anatomical outcomes - ultrasound imaging</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>anatomical outcomes 12 months after surgery evaluated through ultrasound (transvaginal ultrasound to measure size of uterus, length of cervix, perineal ultrasound for 3d imaging of perineal muscles)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>German pelvic floor questionnaire (condition-specific quality of life)</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>condition-specific quality of life 12 months after surgery evaluated through validated german pelvic floor questionnaire (consisting of 4 domains and a total of 42 questions)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clavien Dindo Scale for adverse events</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>assessment of adverse events during the first 12 months after surgery evaluated according to the Clavien Dindo scale from 1-5, with 5 consisting death)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini Nutritional Assessment</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>nutritional assessment 12 months after surgery (evaluated through Mini Nutritional Assessment (from 1-14 points: 12-14 points: normal nutrition, 8-11 points: at risk for malnutrition, 0-7 points: malnutrition)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>pain assessment 12 months after surgery evaluated through Visual Analog Scale (VAS: pictograms of facial expression at different levels ranging from free of pain, to worst possible pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numerical Rating Scale</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>pain assessment 12 months after surgery evaluated through Numeric Rating Scale (NRS: ranging from 0 (no pain) up to 10 (worst possible pain))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Impression of Improvement Index</measure>
      <time_frame>12 months post surgery</time_frame>
      <description>patient impression of improvment assessment 12 months after surgery evaluated through Patient Global Impression of Improvement Index (PGI-I: ranging from 1: very much better to 4: no change)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Pelvic Organ Prolapse</condition>
    <condition>Prolapse</condition>
    <arm_group>
      <arm_group_label>PDS - resorbable suture</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. PDS (0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prolene - non-resorbable sutures</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. Prolene (2-0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>sacrospinous hysteropexy</intervention_name>
      <description>sacrospinous hysteropexy</description>
      <arm_group_label>PDS - resorbable suture</arm_group_label>
      <arm_group_label>Prolene - non-resorbable sutures</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Anterior vaginal wall prolapse beyond the hymen (POP-Q-point Aa or Ba &gt;0) with central&#xD;
               defect&#xD;
  &#xD;
            -  Prolapse of the apical vaginal vault beyond the hymen (POP-Q point C &gt;0) with central&#xD;
               defect&#xD;
  &#xD;
            -  Symptoms of a vaginal bulge&#xD;
  &#xD;
            -  A primary reconstructive operation using sacrospinous hysteropexy is planned&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recurrent prolapse&#xD;
  &#xD;
            -  History of hysterectomy&#xD;
  &#xD;
            -  A primary reconstructive operation with mesh or obliterative surgery is planned&#xD;
  &#xD;
            -  An operation with hysterectomy is planned&#xD;
  &#xD;
            -  Known pelvic malignancy&#xD;
  &#xD;
            -  Known inflammatory disease&#xD;
  &#xD;
            -  Current systemic treatment with glucocorticoids or immunosuppressants&#xD;
  &#xD;
            -  The subject cannot or does not want to participate&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Greta L Carlin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical University of Vienna</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Greta L Carllin, MD</last_name>
      <phone>+43-1-40400-28220</phone>
      <email>greta.carlin@muv.ac.at</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical University of Vienna</name>
        <address>
          <city>Vienna</city>
          <zip>1090</zip>
          <country>Austria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Greta L Carlin, MD</last_name>
        <phone>+43-1-40400-28220</phone>
        <email>greta.carlin@muv.ac.at</email>
      </contact>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
      <investigator_full_name>Greta L Carlin, Dr.med.univ</investigator_full_name>
      <investigator_title>Dr. med. univ.</investigator_title>
    </responsible_party>
    <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>Yes</sharing_ipd>
      <ipd_description>Study Protocol and Statistical Analysis Plan will be public through upload on ClinicalTrials.gov Further information can be shared upon direct request from interested researchers</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>immediately</ipd_time_frame>
      <ipd_access_criteria>Study Protocol and Statistical Analysis Plan will be accessible through ClinicalTrials.gov</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>May 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT05964881/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05964881
  org study id: 2079
  nct id: NCT05964881
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of
        women develop in the course of their lives. There are many different options for surgical
        care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP).
        This technique has been increasingly used in recent years. However, there is still no data on
        whether the fixation sutures should be performed with absorbable or non-absorbable threads.
        Internationally, both types of threads are routinely used and both types of threads are
        described in publications. So far, there is no comparative data on the effectiveness and
        subjective results. The aim of this study is to compare subjective symptom improvement
        Materials & Methods: This is a randomized, single-center superiority study. The sacrospinal
        fixation is performed according to a standardized method and two different types of threads
        (absorbable PDS sutures vs. non-absorbable Prolene sutures) are used for the fixation suture.
        Patients are randomized to either the absorbable PDS sutures group or the non-absorbable
        Prolene sutures group. The primary outcome of interest is the subjective symptom improvement
        12 months after surgery (evaluated using the German version of the pelvic floor
        questionnaire). Secondary outcome variables are anatomical outcomes, condition-specific
        quality of life, and adverse events. 52 patients will be included in the study.
  
        The results of the study will be published in peer-reviewed journals and the results will be
        presented at scientific meetings.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: German pelvic floor questionnaire (subjective symptom improvement)
  time frame: 12 months post surgery
  description: subjective symptom improvement 12 months after surgery evaluated using the German version of the pelvic floor questionnaire, which consist of 4 domains and a total of 42 questions
  measure: anatomical outcomes - POP-Q measurement
  time frame: 12 months post surgery
  description: anatomical outcomes 12 months after surgery evaluated through POP-Q-system (standardised POP-Q scale ranging from 0-4; the higher the number the worse the prolapse)
  measure: anatomical outcomes - ultrasound imaging
  time frame: 12 months post surgery
  description: anatomical outcomes 12 months after surgery evaluated through ultrasound (transvaginal ultrasound to measure size of uterus, length of cervix, perineal ultrasound for 3d imaging of perineal muscles)
  measure: German pelvic floor questionnaire (condition-specific quality of life)
  time frame: 12 months post surgery
  description: condition-specific quality of life 12 months after surgery evaluated through validated german pelvic floor questionnaire (consisting of 4 domains and a total of 42 questions)
  measure: Clavien Dindo Scale for adverse events
  time frame: 12 months post surgery
  description: assessment of adverse events during the first 12 months after surgery evaluated according to the Clavien Dindo scale from 1-5, with 5 consisting death)
  measure: Mini Nutritional Assessment
  time frame: 12 months post surgery
  description: nutritional assessment 12 months after surgery (evaluated through Mini Nutritional Assessment (from 1-14 points: 12-14 points: normal nutrition, 8-11 points: at risk for malnutrition, 0-7 points: malnutrition)
  measure: Visual Analog Scale
  time frame: 12 months post surgery
  description: pain assessment 12 months after surgery evaluated through Visual Analog Scale (VAS: pictograms of facial expression at different levels ranging from free of pain, to worst possible pain)
  measure: Numerical Rating Scale
  time frame: 12 months post surgery
  description: pain assessment 12 months after surgery evaluated through Numeric Rating Scale (NRS: ranging from 0 (no pain) up to 10 (worst possible pain))
  measure: Patient Impression of Improvement Index
  time frame: 12 months post surgery
  description: patient impression of improvment assessment 12 months after surgery evaluated through Patient Global Impression of Improvement Index (PGI-I: ranging from 1: very much better to 4: no change)
  arm group label: PDS - resorbable suture
  arm group type: Active Comparator
  description: Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. PDS (0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament.
  arm group label: Prolene - non-resorbable sutures
  arm group type: Experimental
  description: Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. Prolene (2-0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament.
  intervention type: Procedure
  intervention name: sacrospinous hysteropexy
  description: sacrospinous hysteropexy
  arm group label: PDS - resorbable suture
  arm group label: Prolene - non-resorbable sutures
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Greta L Carlin, MD
  role: Principal Investigator
  affiliation: Medical University of Vienna
  last name: Greta L Carllin, MD
  phone: +43-1-40400-28220
  email: greta.carlin@muv.ac.at
  facility: 
  status: Recruiting
  contact: 
  country: Austria
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Greta L Carlin, Dr.med.univ
  investigator title: Dr. med. univ.
  mesh term: Prolapse
  mesh term: Pelvic Organ Prolapse
  sharing ipd: Yes
  ipd description: Study Protocol and Statistical Analysis Plan will be public through upload on ClinicalTrials.gov Further information can be shared upon direct request from interested researchers
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: immediately
  ipd access criteria: Study Protocol and Statistical Analysis Plan will be accessible through ClinicalTrials.gov
  provided document: 