<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/NCT03782285</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUnion：SSLF-CSI</org_study_id>
    <nct_id>NCT03782285</nct_id>
  </id_info>
  <brief_title>Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients</brief_title>
  <acronym>SSLF-CSI</acronym>
  <official_title>Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center Prospective Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Hospitals affiliated to the China PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai First Maternity and Infant Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanxi Provincial Maternity and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foshan Women and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Suzhou Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chongqing Maternal and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hangzhou Maternal and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Obstetrics and Gynecology Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Francis Hospital, Chicago, USA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas, Southwestern Medical Center at Dallas</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>
      SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament,&#xD;
      either unilaterally or bilaterally. It is usually accomplished with specially designed&#xD;
      equipment in English-language scientific literature. However, these instruments either&#xD;
      reusable or disposable are relatively expensive and difficult in accessibility, and are not&#xD;
      yet widely applied around China. Typical Asian smaller pelvis offers us an optional repair&#xD;
      procedure with conventional surgical instruments instead of special instrument.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Apical prolapse is defined as descent of the uterus and cervix, the cervix alone, or the&#xD;
      post-hysterectomy vaginal cuff down to the hymen, lower vagina, or past the introitus. Among&#xD;
      684,250 POP procedures that were performed in 15 Organization for Economic Co-operation and&#xD;
      Development (OECD) countries in 2012, apical compartment repairs represented 20% of these&#xD;
      procedures. Sacrospinous ligament suspension (SSLF) as a typical native tissue repair&#xD;
      procedure is one of the most widely used vaginal procedures for correcting apical prolapse.&#xD;
      SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament,&#xD;
      either unilaterally or bilaterally usually with specially designed equipment such as&#xD;
      Deschamps ligature carrier or Miya hook. However, these instruments are expensive and are not&#xD;
      yet widely applied in China. Typical Asian smaller pelvis offers us an optional repair&#xD;
      procedure with conventional surgical instruments instead of special instrument. Previous&#xD;
      pilot study from Peking Union Medical College Hospital showed promising curative results with&#xD;
      conventional surgical instruments in Chinese female patients. The investigation may show us a&#xD;
      feasible, economic and effective modified procedure for Asian patients with medium&#xD;
      compartment prolapse.&#xD;
&#xD;
      This is a multi-center, prospective clinical trial. Previous studies using conventional&#xD;
      surgical instruments for 1-year follow-up showed objective cure rate was 98%, subjective&#xD;
      satisfaction was 94%, Considering that the objective cure rate may decrease in multicenter&#xD;
      trials, it is assumed that the objective cure rate of multicenter trials can reach 95%. When&#xD;
      the sample size is at least 79 patients, 80% of the test efficiency can verify that the&#xD;
      objective cure rate is higher than the target value when the bilateral α=0.05. The missing&#xD;
      rate was about 10%. The incidence of SSLF failure requiring other operations method due to&#xD;
      deep pelvic cavity and unsatisfactory exposure by conventional instruments was about 5%. The&#xD;
      final number of cases included in this study should be 100 cases. Ischial spinous fascia&#xD;
      fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by&#xD;
      conventional surgical instruments due to unsatisfactory exposure of spinous fascia. The&#xD;
      research units will collect perioperative data and complete unified format case report form&#xD;
      (CRF) for all selected patients for further analysis. A total of at most 9 months will be&#xD;
      required to complete the study after starting up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 23, 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Success rate of SSLF with conventional instruments</measure>
    <time_frame>up to 36 months after operation</time_frame>
    <description>Symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer &quot;no&quot; for PFDI-20 Questionnaire Question 3, &quot;Do you often see or feel vaginal tumors come out?&quot;.&#xD;
The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire.&#xD;
There is no need of further treatment for prolapse, such as reoperation or pessary.&#xD;
Pelvic MRI evaluation on postoperative 3 months follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative recurrence</measure>
    <time_frame>from 3 months after operation up to 36 months after operation</time_frame>
    <description>Evaluation on the prolapse of the anterior, middle and posterior pelvic confirms POP-Q II degrees and above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analogue scales</measure>
    <time_frame>within 3 days after operation</time_frame>
    <description>postoperative pain evaluation esp. hip pain by visual analogue scales (VAS). Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain)</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, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.</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, pelvic floor distress inventory short form 20(PFDI-20), PFDI-20 scores 0-300, the higher the severer negative influence on patient.</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, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.</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)， PGI-C scores 1-7, the higher, the the severer negative influence on patient.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sacrospinous Ligament Fixation</intervention_name>
    <description>sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia.</description>
    <other_name>ischial spinous fascia fixation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with apical prolapse with POP-Q III or IV who are planned to have unilateral SSLF is&#xD;
        planned&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with apical prolapse with POP-Q III or IV&#xD;
&#xD;
          2. Unilateral (all sutured to right sacrospinous ligament) SSLF is planned，while with&#xD;
             vaginal hysterectomy, anterior/posterior vaginal wall repair or mid-urethral&#xD;
             suspension could be performed simultaneously.&#xD;
&#xD;
          3. Women who have been eligible for long-term follow-up.&#xD;
&#xD;
          4. Women who agreed to participate in the study and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who have surgical history for prolapse&#xD;
&#xD;
          2. Women who have contraindication for surgical procedure&#xD;
&#xD;
          3. Women who are unable to comply with the study procedures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lan Zhu</last_name>
    <role>Study Chair</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yongxian Lu</last_name>
    <role>Principal Investigator</role>
    <affiliation>1st Affiliated hospital of PLA general hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhiyuan Dai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai First Maternity and Infant Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wenyan Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd Affiliated hospital of Anhui Medical college</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhaoai Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shan'xi Province Women's and Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yuling Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foshan Women's and Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shunyu Hou</last_name>
    <role>Principal Investigator</role>
    <affiliation>Suzhou City Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lubin Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chongqing Women's and Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiangjuan Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hangzhou Women's and Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Le Ma</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Obstetrics and Gynecology Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tao Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Statistics Department of Peking Union Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joseph Schaffer</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marko J Jachtorowycz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Francis Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuxin Dai, MD</last_name>
    <phone>0086-010-69156204</phone>
    <email>helen81918@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lan Zhu, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>2nd Affiliated hospital of Anhui Medical college</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenyan Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>1st Affiliated hospital of PLA general hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongxian Lu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuxin Dai, MD</last_name>
      <phone>0086-010-69156204</phone>
      <email>helen81918@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Lan Zhu</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Chongqing Women's and Children's Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lubin Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Foshan Women's and Children's 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>
    </contact>
  </location>
  <location>
    <facility>
      <name>Suzhou City Hospital</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shunyu Hou</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai First Maternity and Infant Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhiyuan Dai</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shan'xi Province Women's and Children's Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>300013</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhaoai Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hangzhou Women's and Children's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangjuan Li</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol. 2015 Jun;212(6):755.e1-755.e27. doi: 10.1016/j.ajog.2015.02.017. Epub 2015 Feb 25.</citation>
    <PMID>25724403</PMID>
  </results_reference>
  <results_reference>
    <citation>Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.</citation>
    <PMID>24142057</PMID>
  </results_reference>
  <results_reference>
    <citation>Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage Ⅲ-Ⅳ pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese.</citation>
    <PMID>28647958</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>apical prolapse</keyword>
  <keyword>sacrospinous Ligament Fixation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03782285
org study id: PekingUnion：SSLF-CSI
nct id: NCT03782285
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament,
      either unilaterally or bilaterally. It is usually accomplished with specially designed
      equipment in English-language scientific literature. However, these instruments either
      reusable or disposable are relatively expensive and difficult in accessibility, and are not
      yet widely applied around China. Typical Asian smaller pelvis offers us an optional repair
      procedure with conventional surgical instruments instead of special instrument.
Apical prolapse is defined as descent of the uterus and cervix, the cervix alone, or the
      post-hysterectomy vaginal cuff down to the hymen, lower vagina, or past the introitus. Among
      684,250 POP procedures that were performed in 15 Organization for Economic Co-operation and
      Development (OECD) countries in 2012, apical compartment repairs represented 20% of these
      procedures. Sacrospinous ligament suspension (SSLF) as a typical native tissue repair
      procedure is one of the most widely used vaginal procedures for correcting apical prolapse.
      SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament,
      either unilaterally or bilaterally usually with specially designed equipment such as
      Deschamps ligature carrier or Miya hook. However, these instruments are expensive and are not
      yet widely applied in China. Typical Asian smaller pelvis offers us an optional repair
      procedure with conventional surgical instruments instead of special instrument. Previous
      pilot study from Peking Union Medical College Hospital showed promising curative results with
      conventional surgical instruments in Chinese female patients. The investigation may show us a
      feasible, economic and effective modified procedure for Asian patients with medium
      compartment prolapse.

      This is a multi-center, prospective clinical trial. Previous studies using conventional
      surgical instruments for 1-year follow-up showed objective cure rate was 98%, subjective
      satisfaction was 94%, Considering that the objective cure rate may decrease in multicenter
      trials, it is assumed that the objective cure rate of multicenter trials can reach 95%. When
      the sample size is at least 79 patients, 80% of the test efficiency can verify that the
      objective cure rate is higher than the target value when the bilateral α=0.05. The missing
      rate was about 10%. The incidence of SSLF failure requiring other operations method due to
      deep pelvic cavity and unsatisfactory exposure by conventional instruments was about 5%. The
      final number of cases included in this study should be 100 cases. Ischial spinous fascia
      fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by
      conventional surgical instruments due to unsatisfactory exposure of spinous fascia. The
      research units will collect perioperative data and complete unified format case report form
      (CRF) for all selected patients for further analysis. A total of at most 9 months will be
      required to complete the study after starting up.
observational model: Cohort
time perspective: Prospective
measure: Success rate of SSLF with conventional instruments
time frame: up to 36 months after operation
description: Symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?".
The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire.
There is no need of further treatment for prolapse, such as reoperation or pessary.
Pelvic MRI evaluation on postoperative 3 months follow-up
measure: Postoperative recurrence
time frame: from 3 months after operation up to 36 months after operation
description: Evaluation on the prolapse of the anterior, middle and posterior pelvic confirms POP-Q II degrees and above.
measure: visual analogue scales
time frame: within 3 days after operation
description: postoperative pain evaluation esp. hip pain by visual analogue scales (VAS). Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain)
measure: symptomatic improvement using validated instruments(PFIQ-7)
time frame: up to 36 months after operation
description: Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
measure: symptomatic improvement using validated instruments(PFDI-20)
time frame: up to 36 months after operation
description: Relief of symptoms using validated instruments, pelvic floor distress inventory short form 20(PFDI-20), PFDI-20 scores 0-300, the higher the severer negative influence on patient.
measure: symptomatic improvement using validated instruments(PISQ-12)
time frame: up to 36 months after operation
description: Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
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)， PGI-C scores 1-7, the higher, the the severer negative influence on patient.
intervention type: Procedure
intervention name: sacrospinous Ligament Fixation
description: sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia.
other name: ischial spinous fascia fixation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lan Zhu
role: Study Chair
affiliation: Peking Union Medical College Hospital
last name: Yongxian Lu
role: Principal Investigator
affiliation: 1st Affiliated hospital of PLA general hospital
last name: Zhiyuan Dai
role: Principal Investigator
affiliation: Shanghai First Maternity and Infant Hospital
last name: Wenyan Wang
role: Principal Investigator
affiliation: 2nd Affiliated hospital of Anhui Medical college
last name: Zhaoai Li
role: Principal Investigator
affiliation: Shan'xi Province Women's and Children's Hospital
last name: Yuling Wang
role: Principal Investigator
affiliation: Foshan Women's and Children's Hospital
last name: Shunyu Hou
role: Principal Investigator
affiliation: Suzhou City Hospital
last name: Lubin Liu
role: Principal Investigator
affiliation: Chongqing Women's and Children's Hospital
last name: Xiangjuan Li
role: Principal Investigator
affiliation: Hangzhou Women's and Children's Hospital
last name: Le Ma
role: Principal Investigator
affiliation: Beijing Obstetrics and Gynecology Hospital
last name: Tao Xu
role: Principal Investigator
affiliation: Statistics Department of Peking Union Medical College
last name: Joseph Schaffer
role: Principal Investigator
affiliation: UT Southwestern Medical Center
last name: Marko J Jachtorowycz
role: Principal Investigator
affiliation: Saint Francis Memorial Hospital
last name: Yuxin Dai, MD
phone: 0086-010-69156204
email: helen81918@163.com
last name: Lan Zhu, MD
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: China
citation: Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol. 2015 Jun;212(6):755.e1-755.e27. doi: 10.1016/j.ajog.2015.02.017. Epub 2015 Feb 25.
PMID: 25724403
citation: Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
PMID: 24142057
citation: Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage Ⅲ-Ⅳ pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese.
PMID: 28647958
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No