<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/NCT03005613</url>
  </required_header>
  <id_info>
    <org_study_id>RC-H0407-8160061244</org_study_id>
    <nct_id>NCT03005613</nct_id>
  </id_info>
  <brief_title>Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation</brief_title>
  <official_title>A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between&#xD;
      Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigational intervention：SSLF or ISFF operations&#xD;
&#xD;
      Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life&#xD;
      Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.&#xD;
&#xD;
      Principal Investigator：Chang Ren, M.D., Department of Obstetrics &amp; Gynecology, Peking Union&#xD;
      Medical College Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College.&#xD;
&#xD;
      Study subjects：Adult patients with symptomatic stage II~IV pelvic organ prolapse will be&#xD;
      eligible if all the inclusion criteria are met and without any reason for exclusion.&#xD;
&#xD;
      Study objectives：The primary objective of this study is to assess the short and mid-term&#xD;
      efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating&#xD;
      stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on&#xD;
      quality of life.&#xD;
&#xD;
      Study design：Prospective, Single-Blind, Randomized, Clinical Trial&#xD;
&#xD;
      Intervention：&#xD;
&#xD;
        -  ISFF group：Patients receive ISFF according to randomization.&#xD;
&#xD;
        -  SSLF group：Patients receive SSLF according to randomization&#xD;
&#xD;
      Sample size：76 patients (38 in ISFF group, 38 in SSLF group)&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      •objective success rates at 3 months after operations.&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
        -  peri-operative parameters .&#xD;
&#xD;
        -  subjective satisfactory rates at 1 year after operations&#xD;
&#xD;
        -  quality of life questionnaires at 1 year after operations&#xD;
&#xD;
      Safety endpoints: complications&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>
  </study_design_info>
  <primary_outcome>
    <measure>objective success</measure>
    <time_frame>3 months after operation</time_frame>
    <description>no prolapse, stage I or only asymptomatic stage II prolapse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic Floor Distress Inventory-20 (PFDI-20)</measure>
    <time_frame>Change from Baseline in PFDI-20 at 3 months and 1 year</time_frame>
    <description>to evaluate the quality of life in 3 domains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic Floor Impact Questionnaire-7 (PFIQ-7)</measure>
    <time_frame>Change from Baseline in PFIQ-7 at 3 months and 1 year</time_frame>
    <description>to evaluate the quality of life in 3 domains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)</measure>
    <time_frame>Change from Baseline in PISQ-12 at 3 months and 1 year</time_frame>
    <description>to evaluate the sexual function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>peri-operative:massive bleeding, organ injury; post-operative: pelvic hematoma, pain, de novo UI, de novo dyspareunia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>3 months after operation</time_frame>
    <description>more than asymptomatic stage II prolapse after 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved)</measure>
    <time_frame>1 year after operation</time_frame>
    <description>Patient's response as improved or greatly improved</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Urogenital Prolapse</condition>
  <arm_group>
    <arm_group_label>sacrospinous ligament fixation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will receive sacrospinous ligament fixation operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ischial spine fascia fixation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will receive ischial spine fascia fixation operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ischial spine fascia fixation</intervention_name>
    <description>The participants will receive ischial spine fascia fixation.</description>
    <arm_group_label>ischial spine fascia fixation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sacrospinous ligament fixation</intervention_name>
    <description>The participants will receive sacrospinous ligament fixation.</description>
    <arm_group_label>sacrospinous ligament fixation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≤65 years, for those scheduled to receive hysterectomy age≥40 years&#xD;
&#xD;
          -  patients with symptomatic stage II~IV uterine or vaginal vault prolapse&#xD;
&#xD;
          -  receiving SSLF or ISFF in the gynecological department at Peking Union Medical College&#xD;
             Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  plans to live abroad within follow-up span&#xD;
&#xD;
          -  contradiction to these two operations: acute genital infection, narrow vagina (less&#xD;
             than two finger-breadth), too-ill to receive operations&#xD;
&#xD;
          -  patients with hip joint problem who could not pose a lithotomy position&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang Ren, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chang Ren, M.D.</last_name>
    <phone>+86-134-886-988-61</phone>
    <email>renchang@pumch.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Ob &amp; Gyn, 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>Chang Ren, M.D.</last_name>
      <phone>0086-10-69156238</phone>
      <email>renchang@pumch.cn</email>
    </contact>
    <investigator>
      <last_name>Chang Ren</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x.</citation>
    <PMID>3342213</PMID>
  </reference>
  <reference>
    <citation>Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7.</citation>
    <PMID>9052607</PMID>
  </reference>
  <reference>
    <citation>Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.</citation>
    <PMID>9083302</PMID>
  </reference>
  <reference>
    <citation>Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.</citation>
    <PMID>20966694</PMID>
  </reference>
  <reference>
    <citation>Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15. doi: 10.1067/mob.2003.101.</citation>
    <PMID>12548203</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.</citation>
    <PMID>20223444</PMID>
  </reference>
  <reference>
    <citation>Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.</citation>
    <PMID>21060988</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 26, 2019</last_update_submitted>
  <last_update_submitted_qc>December 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pelvic organ prolapse</keyword>
  <keyword>Sacrospinous ligament fixation</keyword>
  <keyword>Ischial spine fascia fixation</keyword>
  <keyword>Clinical outcome</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/NCT03005613
org study id: RC-H0407-8160061244
nct id: NCT03005613
lead sponsor: 
has dmc: Yes
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between
      Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Investigational intervention：SSLF or ISFF operations

      Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life
      Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

      Principal Investigator：Chang Ren, M.D., Department of Obstetrics & Gynecology, Peking Union
      Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.

      Study subjects：Adult patients with symptomatic stage II~IV pelvic organ prolapse will be
      eligible if all the inclusion criteria are met and without any reason for exclusion.

      Study objectives：The primary objective of this study is to assess the short and mid-term
      efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating
      stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on
      quality of life.

      Study design：Prospective, Single-Blind, Randomized, Clinical Trial

      Intervention：

        -  ISFF group：Patients receive ISFF according to randomization.

        -  SSLF group：Patients receive SSLF according to randomization

      Sample size：76 patients (38 in ISFF group, 38 in SSLF group)

      Primary endpoint:

      •objective success rates at 3 months after operations.

      Secondary endpoints:

        -  peri-operative parameters .

        -  subjective satisfactory rates at 1 year after operations

        -  quality of life questionnaires at 1 year after operations

      Safety endpoints: complications
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: objective success
time frame: 3 months after operation
description: no prolapse, stage I or only asymptomatic stage II prolapse
measure: Pelvic Floor Distress Inventory-20 (PFDI-20)
time frame: Change from Baseline in PFDI-20 at 3 months and 1 year
description: to evaluate the quality of life in 3 domains
measure: Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
time frame: Change from Baseline in PFIQ-7 at 3 months and 1 year
description: to evaluate the quality of life in 3 domains
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)
time frame: Change from Baseline in PISQ-12 at 3 months and 1 year
description: to evaluate the sexual function
measure: complications
time frame: through study completion, an average of 1 year
description: peri-operative:massive bleeding, organ injury; post-operative: pelvic hematoma, pain, de novo UI, de novo dyspareunia
measure: recurrence rate
time frame: 3 months after operation
description: more than asymptomatic stage II prolapse after 3 months
measure: subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved)
time frame: 1 year after operation
description: Patient's response as improved or greatly improved
arm group label: sacrospinous ligament fixation group
arm group type: Active Comparator
description: The patients will receive sacrospinous ligament fixation operation.
arm group label: ischial spine fascia fixation group
arm group type: Experimental
description: The patients will receive ischial spine fascia fixation operation.
intervention type: Procedure
intervention name: ischial spine fascia fixation
description: The participants will receive ischial spine fascia fixation.
arm group label: ischial spine fascia fixation group
intervention type: Procedure
intervention name: sacrospinous ligament fixation
description: The participants will receive sacrospinous ligament fixation.
arm group label: sacrospinous ligament fixation group
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chang Ren, M.D.
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Chang Ren, M.D.
phone: +86-134-886-988-61
email: renchang@pumch.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x.
PMID: 3342213
citation: Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7.
PMID: 9052607
citation: Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
PMID: 9083302
citation: Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
PMID: 20966694
citation: Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15. doi: 10.1067/mob.2003.101.
PMID: 12548203
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: Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
PMID: 20223444
citation: Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.
PMID: 21060988
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No