<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/NCT03283124</url>
  </required_header>
  <id_info>
    <org_study_id>self-cut mesh vs mesh-kit</org_study_id>
    <nct_id>NCT03283124</nct_id>
  </id_info>
  <brief_title>Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.</brief_title>
  <official_title>A Multicenter Randomized Controlled Non-inferiority Trial Comparing Transvaginal Self-tailored Titanium-coated Polypropylene Mesh Procedure With Mesh-kit Procedure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Medstron Medical Co.Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LinkDoc Technology (Beijing) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on&#xD;
      woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but&#xD;
      the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that&#xD;
      the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low&#xD;
      complication rate. The trial is designed to compare self-tailored titanium-coated&#xD;
      polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of&#xD;
      efficacy, safety and cost-effective .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome&#xD;
      measure is success rate at 1-year follow-up. The second outcomes are subjective improvement&#xD;
      of quality of life, complications and costs. Analysis will be performed according to the&#xD;
      intention to treat principle. Based on comparable success rate of 90% and 10% as the&#xD;
      margin(beta 0.2 and one sided alpha 0.025), about 312 patients in total from 11 centers will&#xD;
      be recruited per group including 10% drop-out. The aims of the research are to demonstrate&#xD;
      whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research&#xD;
      might influence the treatment selection for POP in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 12, 2018</start_date>
  <completion_date type="Anticipated">January 12, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 12, 2020</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 (Outcomes Assessor)</masking>
    <masking_description>participant and investigator are not blinded. outcome assessor who are in charge of follow-up assement is masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>surgical &quot;success&quot;</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms, and no additional treatment for prolapse(surgical or pessary use).&#xD;
Anatomic cure is defined as leading edge above the hymen (i.e Ba, C, Bp&lt;0 cm) Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20 (PFDI-20): &quot;Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>anatomic outcomes</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptomatic improvement using validated instruments(PFIQ-7)</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>Relief of symptoms using validated instruments(PFIQ-7) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptomatic improvement using validated instruments(PFDI-20)</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>Relief of symptoms using validated instruments(PFDI-20) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptomatic improvement using validated instruments(PISQ-12)</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>Relief of symptoms using validated instruments(PISQ-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptomatic improvement using patient global impression of change (PGI-C)</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>Relief of symptoms using patient global impression of change (PGI-C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative and post operative complications</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>using IUGA/ICS joint terminology CTS coding system and dingo system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post operative pain</measure>
    <time_frame>within 3 days after operation</time_frame>
    <description>visual analogue scales (VAS) were used to evaluate the degree of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital costs</measure>
    <time_frame>up to 4 weeks after operation</time_frame>
    <description>hospitlization expenses</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">312</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>self-cut mesh procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This procedure is transvaginal mesh implantation surgery for POP patients. Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair. The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10*15cm) which is much cheaper and readily available. Patients could have transvaginal hysterectomy concomitantly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mesh-kit procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pelvic floor reconstructive surgery</intervention_name>
    <description>transvaginal mesh implantation for pelvic organ prolapse</description>
    <arm_group_label>mesh-kit procedure</arm_group_label>
    <arm_group_label>self-cut mesh procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:More than 50 years old with 3 years after menopause or more than 55 years old, but&#xD;
             less than 75 years old.&#xD;
&#xD;
          -  Subject must have severe apical or anterior vaginal prolapse (stage III-IV), with&#xD;
             moderate posterior vaginal prolapse(stage I-II). This is defined as ( C &gt; +1cm OR Ba &gt;&#xD;
             +1cm, with Bp ≤+1cm by the POP-Q). This is the most common modality of multiple&#xD;
             compartment POP in clinic.&#xD;
&#xD;
          -  Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3,&#xD;
             response of 2 or higher (i.e., responses of &quot;somewhat&quot;, &quot;moderately&quot;, or &quot;quite a&#xD;
             bit&quot;).&#xD;
&#xD;
          -  Desires transvaginal mesh treatment for primary or recurrent, symptomatic uterovaginal&#xD;
             prolapse.&#xD;
&#xD;
          -  Concomitant hysterectomy when indicated. But concomitant anti-incontinence surgeries&#xD;
             will not be enrolled.&#xD;
&#xD;
          -  Subject is willing and able to comply with the follow-up regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant or intends to become pregnant in the future&#xD;
&#xD;
          -  Subject has an active or chronic systemic infection including any gynecologic&#xD;
             infection, untreated urinary tract infection (UTI) or tissue necrosis&#xD;
&#xD;
          -  Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder,&#xD;
             colo-rectal or cervical)&#xD;
&#xD;
          -  Subject has had prior or is currently undergoing radiation, laser therapy, or&#xD;
             chemotherapy in the pelvic area&#xD;
&#xD;
          -  Subject has taken systemic steroids (within the last month), or immunosuppressive or&#xD;
             immunomodulatory treatment (within the last 3 months)&#xD;
&#xD;
          -  Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus&#xD;
             erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis,&#xD;
             polymyalgia rheumatica)&#xD;
&#xD;
          -  Subject has chronic systemic pain that includes the pelvic area or chronic focal pain&#xD;
             that involves the pelvis&#xD;
&#xD;
          -  Subject has uncontrolled diabetes mellitus (DM)&#xD;
&#xD;
          -  Subject has a known neurologic or medical condition affecting bladder function (e.g.,&#xD;
             multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)&#xD;
&#xD;
          -  Subject has had previous prolapse repair with mesh in the target compartment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lan Zhu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lan Zhu</last_name>
    <phone>86-10-69155749</phone>
    <email>zhu_julie@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juan Chen</last_name>
    <phone>86-10-69155749</phone>
    <email>pumchcj@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fosha Maternal and Child Health Care Hospital</name>
      <address>
        <city>Foshan</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuling Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical College</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiaowei zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Changsha Maternal and Child Health Care Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Binan Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>guangshi Tao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuxi Maternal and Child Health Care Hospital</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Gong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peishu Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial People's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangyang Jiang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sichuan University West China Second University Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Ürümqi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gulina Ababaikeli</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>the People's Hospital of Xinjiang Uygur Autonomous Region</name>
      <address>
        <city>Ürümqi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hatiguli Nisier</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>May 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>March 4, 2019</last_update_submitted>
  <last_update_submitted_qc>March 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>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/NCT03283124
org study id: self-cut mesh vs mesh-kit
nct id: NCT03283124
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on
      woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but
      the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that
      the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low
      complication rate. The trial is designed to compare self-tailored titanium-coated
      polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of
      efficacy, safety and cost-effective .
The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome
      measure is success rate at 1-year follow-up. The second outcomes are subjective improvement
      of quality of life, complications and costs. Analysis will be performed according to the
      intention to treat principle. Based on comparable success rate of 90% and 10% as the
      margin(beta 0.2 and one sided alpha 0.025), about 312 patients in total from 11 centers will
      be recruited per group including 10% drop-out. The aims of the research are to demonstrate
      whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research
      might influence the treatment selection for POP in China.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: participant and investigator are not blinded. outcome assessor who are in charge of follow-up assement is masked.
measure: surgical "success"
time frame: up to 36 months after operation
description: Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms, and no additional treatment for prolapse(surgical or pessary use).
Anatomic cure is defined as leading edge above the hymen (i.e Ba, C, Bp<0 cm) Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20 (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?
measure: anatomic outcomes
time frame: up to 36 months after operation
description: anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score.
measure: symptomatic improvement using validated instruments(PFIQ-7)
time frame: up to 36 months after operation
description: Relief of symptoms using validated instruments(PFIQ-7) .
measure: symptomatic improvement using validated instruments(PFDI-20)
time frame: up to 36 months after operation
description: Relief of symptoms using validated instruments(PFDI-20) .
measure: symptomatic improvement using validated instruments(PISQ-12)
time frame: up to 36 months after operation
description: Relief of symptoms using validated instruments(PISQ-12)
measure: symptomatic improvement using patient global impression of change (PGI-C)
time frame: up to 36 months after operation
description: Relief of symptoms using patient global impression of change (PGI-C)
measure: intraoperative and post operative complications
time frame: up to 36 months after operation
description: using IUGA/ICS joint terminology CTS coding system and dingo system
measure: post operative pain
time frame: within 3 days after operation
description: visual analogue scales (VAS) were used to evaluate the degree of pain.
measure: Hospital costs
time frame: up to 4 weeks after operation
description: hospitlization expenses
arm group label: self-cut mesh procedure
arm group type: Active Comparator
description: This procedure is transvaginal mesh implantation surgery for POP patients. Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair. The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10*15cm) which is much cheaper and readily available. Patients could have transvaginal hysterectomy concomitantly.
arm group label: mesh-kit procedure
arm group type: Active Comparator
description: This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly.
intervention type: Procedure
intervention name: pelvic floor reconstructive surgery
description: transvaginal mesh implantation for pelvic organ prolapse
arm group label: mesh-kit procedure
arm group label: self-cut mesh procedure
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lan Zhu
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Lan Zhu
phone: 86-10-69155749
email: zhu_julie@sina.com
last name: Juan Chen
phone: 86-10-69155749
email: pumchcj@sina.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: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No