<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/NCT01670682</url>
  </required_header>
  <id_info>
    <org_study_id>pumch-gyn-03</org_study_id>
    <nct_id>NCT01670682</nct_id>
  </id_info>
  <brief_title>Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III</brief_title>
  <official_title>A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous&#xD;
      fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh&#xD;
      are both developed in China for vaginal apex fixation, the former is native tissue repairs,&#xD;
      and the latter is augmentation with mesh.&#xD;
&#xD;
      This study is designed to determine the effectiveness and safety of ischia spinous fascia&#xD;
      fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh&#xD;
      for the treatment of pelvic organ prolapse stage III.&#xD;
&#xD;
      Patients enrolled into the study will be followed up for up to 3 years after surgery.&#xD;
      Evaluation will take place during surgery and postoperative visit. Stage of prolapse before&#xD;
      and after surgery, patient satisfaction through quality of life and sexual function&#xD;
      questionnaires before and after surgery, and peri-operative complication rates will be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms&#xD;
      such as loss of control of the bowel or bladder, and may also cause problems with patient's&#xD;
      sex life. An ideal procedure for vaginal apical support should provide a durable suspension,&#xD;
      have minimal complications, and not affect sexual or visceral function.&#xD;
&#xD;
      Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia&#xD;
      fixation procedure with native tissue and modified total pelvic floor reconstructive surgery&#xD;
      with mesh. They are both developed and popular in China. Clinical practice showed that they&#xD;
      were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year&#xD;
      follow-up were about 10%, and quality of life improved significantly from the baseline, while&#xD;
      the.complications are different.&#xD;
&#xD;
      The purpose of this multicenter, prospective, and comparative study is to evaluate the&#xD;
      effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ&#xD;
      prolapse Stage III in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>•Anatomical improvement according to POP-Q score.</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>•Anatomical improvement according to POP-Q score.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>•Anatomical improvement according to POP-Q score.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>•Anatomical improvement according to POP-Q score.</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>•Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.</measure>
    <time_frame>At discharge, an expected average of 5 days after operation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>•Pain score measured using Visual Analog Scale (VAS).</measure>
    <time_frame>24 hours post surgery and at the 6-week visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>•Presence/absence of complications (composite score).</measure>
    <time_frame>Up to 6 weeks.</time_frame>
    <description>The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>•Change from baseline in PFIQ-7 scores.</measure>
    <time_frame>1 year, 2 years and 3 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>•In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)</measure>
    <time_frame>1 year, 2 years and 3 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>•Subject global impression assessed on a 5 point Likert scale</measure>
    <time_frame>1 year, 2 years and 3 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>•Presence/absence of complications (composite score)</measure>
    <time_frame>Up to 3 years.</time_frame>
    <description>Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, mesh erosion, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>fascia fixation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>procedure: ischia spinous fascia fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mesh group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ischia spinous fascia fixation</intervention_name>
    <description>Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.</description>
    <arm_group_label>fascia fixation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Modified Pelvic Floor Reconstruction Surgery with Mesh</intervention_name>
    <description>Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.</description>
    <arm_group_label>mesh group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>polypropylene mesh(Gynemesh)</intervention_name>
    <description>Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.</description>
    <arm_group_label>mesh group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidates with symptomatic pelvic organ prolapse of POP-Q Stage III, suitable for&#xD;
             surgical repair.&#xD;
&#xD;
          -  Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.&#xD;
&#xD;
          -  Age ≥ 55 years.&#xD;
&#xD;
          -  Agrees to participate in the study, including completion of all study-related&#xD;
             procedures, evaluations and questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous repair of pelvic organ prolapse involving insertion of mesh.&#xD;
&#xD;
          -  Experimental drug or experimental medical device within 3 months prior to the planned&#xD;
             procedure.&#xD;
&#xD;
          -  Active genital, urinary or systemic infection at the time of the surgical procedure.&#xD;
             Surgery may be delayed in such subjects until the infection is cleared.&#xD;
&#xD;
          -  Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.&#xD;
&#xD;
          -  History of chemotherapy or pelvic radiation therapy.&#xD;
&#xD;
          -  Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease,&#xD;
             multiple sclerosis, spinal cord injury or trauma).&#xD;
&#xD;
          -  Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis,&#xD;
             endometriosis, coccydynia, vulvodynia).&#xD;
&#xD;
          -  Nursing or pregnant or intends future pregnancy.&#xD;
&#xD;
          -  Chronic cough not well-controlled.&#xD;
&#xD;
          -  BMI ≥ 30.&#xD;
&#xD;
          -  In the investigator's opinion, any medical condition or psychiatric illness that could&#xD;
             potentially be life threatening or affect their ability to complete the study visits&#xD;
             according to this protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lan Zhu</last_name>
    <phone>13911714696</phone>
    <email>zhu_julie@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juan Chen</last_name>
    <phone>13521354364</phone>
    <email>pumchcj@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Foshan Maternal and Child Health Hospital</name>
      <address>
        <city>Foshan</city>
        <state>Guangdong</state>
        <zip>528000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuling Wang</last_name>
      <phone>13049161630</phone>
      <email>Wujun701121@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518036</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huan Li</last_name>
      <phone>13828700921</phone>
      <email>szbdlh@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>the Third Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luwen Wang</last_name>
      <phone>13607683293</phone>
      <email>Wangluwen_688@sohu.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhijun Xia</last_name>
      <phone>13840118800</phone>
      <email>xiazhijunhosp2@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Chen</last_name>
      <phone>13521354364</phone>
      <email>pumchcj@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>February 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 18, 2012</last_update_submitted>
  <last_update_submitted_qc>August 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stage III</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>
  <!-- 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/NCT01670682
org study id: pumch-gyn-03
nct id: NCT01670682
lead sponsor: 
has dmc: No
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous
      fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh
      are both developed in China for vaginal apex fixation, the former is native tissue repairs,
      and the latter is augmentation with mesh.

      This study is designed to determine the effectiveness and safety of ischia spinous fascia
      fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh
      for the treatment of pelvic organ prolapse stage III.

      Patients enrolled into the study will be followed up for up to 3 years after surgery.
      Evaluation will take place during surgery and postoperative visit. Stage of prolapse before
      and after surgery, patient satisfaction through quality of life and sexual function
      questionnaires before and after surgery, and peri-operative complication rates will be
      evaluated.
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms
      such as loss of control of the bowel or bladder, and may also cause problems with patient's
      sex life. An ideal procedure for vaginal apical support should provide a durable suspension,
      have minimal complications, and not affect sexual or visceral function.

      Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia
      fixation procedure with native tissue and modified total pelvic floor reconstructive surgery
      with mesh. They are both developed and popular in China. Clinical practice showed that they
      were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year
      follow-up were about 10%, and quality of life improved significantly from the baseline, while
      the.complications are different.

      The purpose of this multicenter, prospective, and comparative study is to evaluate the
      effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ
      prolapse Stage III in China.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: •Anatomical improvement according to POP-Q score.
time frame: 6 weeks
measure: •Anatomical improvement according to POP-Q score.
time frame: 1 year
measure: •Anatomical improvement according to POP-Q score.
time frame: 2 years
measure: •Anatomical improvement according to POP-Q score.
time frame: 3 years
measure: •Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.
time frame: At discharge, an expected average of 5 days after operation.
measure: •Pain score measured using Visual Analog Scale (VAS).
time frame: 24 hours post surgery and at the 6-week visit
measure: •Presence/absence of complications (composite score).
time frame: Up to 6 weeks.
description: The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale.
measure: •Change from baseline in PFIQ-7 scores.
time frame: 1 year, 2 years and 3 years.
measure: •In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)
time frame: 1 year, 2 years and 3 years.
measure: •Subject global impression assessed on a 5 point Likert scale
time frame: 1 year, 2 years and 3 years.
measure: •Presence/absence of complications (composite score)
time frame: Up to 3 years.
description: Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, mesh erosion, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.
arm group label: fascia fixation group
arm group type: Active Comparator
description: procedure: ischia spinous fascia fixation
arm group label: mesh group
arm group type: Active Comparator
description: Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh
intervention type: Procedure
intervention name: ischia spinous fascia fixation
description: Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
arm group label: fascia fixation group
intervention type: Procedure
intervention name: Modified Pelvic Floor Reconstruction Surgery with Mesh
description: Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.
arm group label: mesh group
intervention type: Device
intervention name: polypropylene mesh(Gynemesh)
description: Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.
arm group label: mesh group
criteria: 
gender: Female
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lan Zhu
phone: 13911714696
email: zhu_julie@sina.com
last name: Juan Chen
phone: 13521354364
email: pumchcj@sina.com
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