<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/NCT02246387</url>
  </required_header>
  <id_info>
    <org_study_id>2013/2093/REK</org_study_id>
    <nct_id>NCT02246387</nct_id>
  </id_info>
  <brief_title>Follow-up Study After Manchester Operation for Pelvic Organ Prolapse</brief_title>
  <acronym>MAP-POP</acronym>
  <official_title>Does the Manchester Operation for Pelvic Organ Prolapse Give Sufficient Apical Fixation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in&#xD;
      the investigators department and the Manchester operation the preferred procedure. The&#xD;
      investigators long-term reoperation rates for pevic organ prolapse are very low, as&#xD;
      documented in the investigators previous long-term follow-up study (Oversand et al,&#xD;
      International Urogynecology Journal 2013), however the data were retrospective and patients&#xD;
      with avulsions of the levator ani muscle were not identified. The investigators hypothesize&#xD;
      that correct fixation and elevation of the vaginal apex, as part of a three-compartment&#xD;
      repair procedure, is essential in the POP surgical repair, also when treating women with&#xD;
      levator ani avulsions.&#xD;
&#xD;
      The purpose of this study is to:&#xD;
&#xD;
        -  prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the&#xD;
           3-compartment Manchester procedure) gives an adequate elevation and fixation of the&#xD;
           vaginal apex.&#xD;
&#xD;
        -  assess changes in subjective symptoms between the preoperative evaluation and the 1 and&#xD;
           5-year postoperative evaluations.&#xD;
&#xD;
        -  evaluate whether the patients identified with levator avulsions in the investigators&#xD;
           population have an increased risk of failure (objectively and subjectively).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many studies have shown high recurrence rates after POP surgical repair using native tissue&#xD;
      techniques, and this led to the introduction of synthetic meshes in vaginal repair in the&#xD;
      early 2000s. However the use of mesh has recently been put under scrutiny due to a high risk&#xD;
      of complications, such as mesh exposure. The gran majority of the investigators patients are&#xD;
      operated with native tissue repairs, about 60% of them by a Manchester procedure, where&#xD;
      ligament plication is an essential part of the procedure. The investigators previous study&#xD;
      documented high patient satisfaction and low risk of recurrence, but the data available were&#xD;
      mainly collected retrospectively and no data were available on possible levator avulsions.&#xD;
      Lateral defects caused by avulsions of the levator ani muscle represent a special sub-group&#xD;
      amongst patients with POP, and are shown in several studies to have higher recurrence rates.&#xD;
      There is no consensus on how to best repair a lateral defect in a POP, but since the&#xD;
      prevalence of levator avulsions in patients with POP is shown to be high, the investigators&#xD;
      find it credible that the Manchester Operation can give good results .&#xD;
&#xD;
      The main justification for this study is that the investigators already have identified a&#xD;
      surgical technique that has documented excellent results, but studies with more detailed data&#xD;
      quality are needed in order to better evaluate the procedure's advantages and potential&#xD;
      disadvantages. As the use of mesh in vaginal surgery has shown unacceptable high risks of new&#xD;
      and serious complications, there is an international focus and interest in traditional native&#xD;
      tissue repairs and how to optimize their performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Percentage with POP-Q point C equal to or less than -5 at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.</measure>
    <time_frame>Up to 7 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in point C and D at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.</measure>
    <time_frame>Up to 7 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).</measure>
    <time_frame>Up to 7 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dyspareunia between the preoperative evaluation and at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).</measure>
    <time_frame>Up to 7 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>De novo urinary incontinence at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).</measure>
    <time_frame>Up to 7 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">209</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Manchester Operation</arm_group_label>
    <description>Manchester Operation: Native tissue repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Manchester Operation</intervention_name>
    <description>A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.</description>
    <arm_group_label>Manchester Operation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women referred to out outpatient clinic for surgery for pelvic organ prolapse.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged ≥ 18 years, understanding and reading Scandinavian or English language and&#xD;
             being able to sign an informed consent. Non- Scandinavian speakers can be enrolled in&#xD;
             the study as long as they understand and can communicate in English or Norwegian.&#xD;
&#xD;
          -  Subjective distress from pelvic organ prolapse&#xD;
&#xD;
          -  Cystocele Stage I - III with descent of the cervix Stage I-III, with or without a&#xD;
             defect of the posterior wall (rectocele, enterocele, hypotrophic perineum).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous total hysterectomy (including removal of the cervix and the cardinal&#xD;
             ligaments) or previous subtotal hysterectomy (removal of copus uteri).&#xD;
&#xD;
          -  Previous surgery for POP&#xD;
&#xD;
          -  Patients with a true Uterine prolapse with a descent of the corpus uteri stage II-III&#xD;
             and not just an elongated cervix, as this group may benefit from other procedures than&#xD;
             a Manchester operation (vaginal hysterectomy and sacrospinous fixation)&#xD;
&#xD;
          -  Unable to understand patient information (in Norwegian or English) and sign an&#xD;
             informed consent.&#xD;
&#xD;
          -  Patients in whom a colpocleisis (closing of the vagina) is deemed the better surgical&#xD;
             treatment, such as in elderly women not sexually active and not interested in future&#xD;
             vaginal intercourse.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sissel H Oversand, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anne C Staff, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital; University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rune Svenningsen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oslo University Hospital; University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gynekologisk avdeling, Oslo Universitetssykehus Ullevål</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Sissel Oversand</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>Gynecologic Surgery Procedures</keyword>
  <keyword>Treatment 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>
  <!-- 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/NCT02246387
org study id: 2013/2093/REK
nct id: NCT02246387
lead sponsor: 
has dmc: No
Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in
      the investigators department and the Manchester operation the preferred procedure. The
      investigators long-term reoperation rates for pevic organ prolapse are very low, as
      documented in the investigators previous long-term follow-up study (Oversand et al,
      International Urogynecology Journal 2013), however the data were retrospective and patients
      with avulsions of the levator ani muscle were not identified. The investigators hypothesize
      that correct fixation and elevation of the vaginal apex, as part of a three-compartment
      repair procedure, is essential in the POP surgical repair, also when treating women with
      levator ani avulsions.

      The purpose of this study is to:

        -  prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the
           3-compartment Manchester procedure) gives an adequate elevation and fixation of the
           vaginal apex.

        -  assess changes in subjective symptoms between the preoperative evaluation and the 1 and
           5-year postoperative evaluations.

        -  evaluate whether the patients identified with levator avulsions in the investigators
           population have an increased risk of failure (objectively and subjectively).
Many studies have shown high recurrence rates after POP surgical repair using native tissue
      techniques, and this led to the introduction of synthetic meshes in vaginal repair in the
      early 2000s. However the use of mesh has recently been put under scrutiny due to a high risk
      of complications, such as mesh exposure. The gran majority of the investigators patients are
      operated with native tissue repairs, about 60% of them by a Manchester procedure, where
      ligament plication is an essential part of the procedure. The investigators previous study
      documented high patient satisfaction and low risk of recurrence, but the data available were
      mainly collected retrospectively and no data were available on possible levator avulsions.
      Lateral defects caused by avulsions of the levator ani muscle represent a special sub-group
      amongst patients with POP, and are shown in several studies to have higher recurrence rates.
      There is no consensus on how to best repair a lateral defect in a POP, but since the
      prevalence of levator avulsions in patients with POP is shown to be high, the investigators
      find it credible that the Manchester Operation can give good results .

      The main justification for this study is that the investigators already have identified a
      surgical technique that has documented excellent results, but studies with more detailed data
      quality are needed in order to better evaluate the procedure's advantages and potential
      disadvantages. As the use of mesh in vaginal surgery has shown unacceptable high risks of new
      and serious complications, there is an international focus and interest in traditional native
      tissue repairs and how to optimize their performance.
observational model: Cohort
time perspective: Prospective
measure: Percentage with POP-Q point C equal to or less than -5 at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
time frame: Up to 7 years
measure: Changes in point C and D at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
time frame: Up to 7 years
measure: Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
time frame: Up to 7 years
measure: Changes in dyspareunia between the preoperative evaluation and at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
time frame: Up to 7 years
measure: De novo urinary incontinence at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
time frame: Up to 7 years
arm group label: Manchester Operation
description: Manchester Operation: Native tissue repair
intervention type: Procedure
intervention name: Manchester Operation
description: A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.
arm group label: Manchester Operation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sissel H Oversand, MD
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Anne C Staff, PhD
role: Study Chair
affiliation: Oslo University Hospital; University of Oslo
last name: Rune Svenningsen, PhD
role: Study Director
affiliation: Oslo University Hospital; University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Sissel Oversand
investigator title: MD
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse