<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/NCT02193607</url>
  </required_header>
  <id_info>
    <org_study_id>PTOS-2014</org_study_id>
    <nct_id>NCT02193607</nct_id>
  </id_info>
  <brief_title>Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients</brief_title>
  <acronym>PTOS</acronym>
  <official_title>Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial</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>
      1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure,&#xD;
           when added to a planned improved reconstruction pelvic surgery, improves the rate of&#xD;
           urinary stress continence in subjects with occult stress incontinence.&#xD;
&#xD;
        2. Observe the immediate and short-term complications, overall urinary tract function, and&#xD;
           other aspects of pelvic health between subjects with and without a TVT-O procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure,&#xD;
      when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic&#xD;
      organ prolapse, improves the rate of urinary stress continence in subjects with occult stress&#xD;
      incontinence. Secondary aims include comparison of immediate and short-term complications,&#xD;
      overall urinary tract function, and other aspects of pelvic health between subjects with and&#xD;
      without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse&#xD;
      reduction and 1 hour pad test will also be compared between subjects with and without a&#xD;
      concomitant TVT-O procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stress incontinence</measure>
    <time_frame>3 months to 2 years post-operation</time_frame>
    <description>Urine loss from physical activity such as coughing, sneezing or laughing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immediate and short-term complications</measure>
    <time_frame>Intraoperative and 2 years post-opeartion</time_frame>
    <description>Immediate and short-term complications such as hemorrhage, bladder perforation and infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall urinary tract function</measure>
    <time_frame>3 months, 12 months and 2 years post-operation</time_frame>
    <description>Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">196</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Other Specified Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>No TVT-O</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Improved reconstruction pelvic surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined surgery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Improved reconstruction pelvic surgery TVT-O procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TVT-O</intervention_name>
    <description>Artificial mesh belt is placed in the middle urethra to provide support to remain no leak</description>
    <arm_group_label>Combined surgery group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Improved reconstruction pelvic surgery</intervention_name>
    <description>Repair of severe pelvic organ prolapse with mesh.</description>
    <arm_group_label>Combined surgery group</arm_group_label>
    <arm_group_label>No TVT-O</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In the absence of medical contraindications for improved pelvic floor reconstruction&#xD;
             surgery and the TVT-O surgery&#xD;
&#xD;
          -  Bulge of paries anterior vaginas stage III-IV&#xD;
&#xD;
          -  Uterine prolapse stage II-II&#xD;
&#xD;
          -  Without symptoms of stress urinary incontinence&#xD;
&#xD;
          -  Screening tests of occult stress urinary incontinence(OSUI) should be positive&#xD;
&#xD;
          -  ≥55 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Illegible to follow up after surgery&#xD;
&#xD;
          -  Previous surgery for stress urinary incontinence&#xD;
&#xD;
          -  Unfinished data collection before surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lan Zhu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Obstetrics and Gynecology Department, Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.</citation>
    <PMID>22716974</PMID>
  </reference>
  <reference>
    <citation>Schierlitz L, Dwyer PL, Rosamilia A, De Souza A, Murray C, Thomas E, Hiscock R, Achtari C. Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial. Int Urogynecol J. 2014 Jan;25(1):33-40. doi: 10.1007/s00192-013-2150-7. Epub 2013 Jun 28.</citation>
    <PMID>23812579</PMID>
  </reference>
  <reference>
    <citation>Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.</citation>
    <PMID>16611949</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Occult stress incontinence</keyword>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>Surgical Intervention</keyword>
  <keyword>TVT-O(Tension-free vaginal tape-obturator)</keyword>
  <keyword>Improved Reconstructive Pelvic Surgery</keyword>
  <keyword>Combined Surgery</keyword>
  <keyword>Two-step Approach</keyword>
  <keyword>Prophylactic Incontinence Procedure</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <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/NCT02193607
org study id: PTOS-2014
nct id: NCT02193607
lead sponsor: 
has dmc: No
1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure,
           when added to a planned improved reconstruction pelvic surgery, improves the rate of
           urinary stress continence in subjects with occult stress incontinence.

        2. Observe the immediate and short-term complications, overall urinary tract function, and
           other aspects of pelvic health between subjects with and without a TVT-O procedure.
The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure,
      when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic
      organ prolapse, improves the rate of urinary stress continence in subjects with occult stress
      incontinence. Secondary aims include comparison of immediate and short-term complications,
      overall urinary tract function, and other aspects of pelvic health between subjects with and
      without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse
      reduction and 1 hour pad test will also be compared between subjects with and without a
      concomitant TVT-O procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Stress incontinence
time frame: 3 months to 2 years post-operation
description: Urine loss from physical activity such as coughing, sneezing or laughing.
measure: Immediate and short-term complications
time frame: Intraoperative and 2 years post-opeartion
description: Immediate and short-term complications such as hemorrhage, bladder perforation and infection.
measure: Overall urinary tract function
time frame: 3 months, 12 months and 2 years post-operation
description: Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test.
arm group label: No TVT-O
arm group type: Active Comparator
description: Improved reconstruction pelvic surgery
arm group label: Combined surgery group
arm group type: Experimental
description: Improved reconstruction pelvic surgery TVT-O procedure
intervention type: Procedure
intervention name: TVT-O
description: Artificial mesh belt is placed in the middle urethra to provide support to remain no leak
arm group label: Combined surgery group
intervention type: Procedure
intervention name: Improved reconstruction pelvic surgery
description: Repair of severe pelvic organ prolapse with mesh.
arm group label: Combined surgery group
arm group label: No TVT-O
criteria: 
gender: Female
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Lan Zhu, MD
role: Study Director
affiliation: Peking Union Medical College Hospital
facility: 
country: China
citation: Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
PMID: 22716974
citation: Schierlitz L, Dwyer PL, Rosamilia A, De Souza A, Murray C, Thomas E, Hiscock R, Achtari C. Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial. Int Urogynecol J. 2014 Jan;25(1):33-40. doi: 10.1007/s00192-013-2150-7. Epub 2013 Jun 28.
PMID: 23812579
citation: Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.
PMID: 16611949
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse