<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/NCT03772691</url>
  </required_header>
  <id_info>
    <org_study_id>LSS</org_study_id>
    <nct_id>NCT03772691</nct_id>
  </id_info>
  <brief_title>Lateral Suspension and Sacropexy for Pelvic Organ Prolapse</brief_title>
  <official_title>Lateral Suspension Versus Sacropexy for Treatment of Apical Pelvic Organ Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      Pelvic organ prolapse (POP) is considered one of the commonest gynecologic health problems&#xD;
      all over the world. Pelvic organ prolapse (POP) is common and can be seen in up to 50% or&#xD;
      more of parous women. The annual aggregated rate of associated surgery for pelvic organ&#xD;
      prolapse is in the range of 10-30 per 10,000 women. It is estimated that women have an 11-19%&#xD;
      life-time risk of undergoing surgery for POP. This rate is projected to increase over the&#xD;
      next 2-3 decades. Apical POP refers any descent of the cervix or the vaginal cuff scar(as&#xD;
      after hysterectomy) below a point which is 2 cm less than the total vaginal length about the&#xD;
      plane of the hymen. Apical POP is due to defect in apical support with damage to the cardinal&#xD;
      and uterosacral ligaments. Apical pelvic organ prolapse is a common issue in our country with&#xD;
      significant incidence rate due to many predisposing factors including increasing age, higher&#xD;
      gravidity and parity (especially the number of vaginal births)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      By one estimate, the demand for health care services related to pelvic floor disorders will&#xD;
      increase at twice the rate of the population itself . So we need adequate understanding of&#xD;
      the best surgical method for treating apical POP which is accepted worldwide and also must be&#xD;
      cost effective with least perioperative complications. Abdominal sacropexy is considered now&#xD;
      the gold standard operation for treatment of apical pelvic organ prolapse. In this technique,&#xD;
      the mesh is ﬁxed to the anterior longitudinal ligament at the sacral promontory. It is used&#xD;
      either with uterine preservation (sacrohysteropexy) or after hysterectomy (sacrocolpopexy)&#xD;
      for treatment of vault prolapse .However , many intraoperative complication can occur&#xD;
      including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal&#xD;
      injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative&#xD;
      complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral&#xD;
      osteomyelitis . Also, despite that sacropexy provide good apical support, but the high&#xD;
      prevalence of cystocele and urinary tract symptoms in patients reaches up to 8% .&#xD;
      Consequently, it is not surprising that the majority of failures following sacrocolpopexy&#xD;
      occur in the anterior compartment. Lateral suspension with mesh was ﬁrst reported by&#xD;
      Dubuisson in 1998 for the treatment of pelvic organ prolapse . The lateral suspension avoids&#xD;
      both the risk of vascular injury and nerve damage of sacrocolpopexy with success rate up to&#xD;
      88% of cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of occurance of denovo stress urinary incontinence</measure>
    <time_frame>18 months</time_frame>
    <description>number of patients developed new onset postoperative stress urinary incontinence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The rate of Improvement of urinary symptoms</measure>
    <time_frame>18 months</time_frame>
    <description>Improvement of symptoms using Abramsc Development and psychometric evaluation of the International consultation on incontinence and Vaginal Symptoms Questionnaire maximum score:178, minimum score:0 high score means better outcome , low score means worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>objective assessment of prolapse stage</measure>
    <time_frame>18 months</time_frame>
    <description>improvement of POP-Q system postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of sexual function</measure>
    <time_frame>18 months</time_frame>
    <description>improvement of female sexual function index postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>lateral suspension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sacropexy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Our ﬁrst passage is the peritoneum incision overlying the sacral promontory (L5-S1) to expose the anterior longitudinal ligament, which is the anchorage point of the mesh on the sacrum. We create a tunnel under the peritoneum on the right side through the cul-de-sac of Douglas till reach the cervix or vaginal cuff (after hysterectomy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lateral suspension</intervention_name>
    <description>• The vesico-vaginal space was found between the bladder and the anterior vaginal wall in the fascia plane. A polypropylene mesh (25 , 25 cm, Ethicon, Inc., Somerville, NJ) was cut to obtain two long arms (15-20 mm wide) and a rectangular piece (4-7 cm wide).</description>
    <arm_group_label>lateral suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sacropexy</intervention_name>
    <description>• The mesh is fixed on the anterior longitudinal ligament of sacrum with separated number 1 prolene sutures. The other end of the mesh is passed through the peritoneal tunnel and fixed to the cervix using prolene 1 and vicryl o sutures.</description>
    <arm_group_label>sacropexy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apical prolapse Stage 2-4 according to POP-Q system&#xD;
&#xD;
          -  Uterine preservation or after hysterectomy&#xD;
&#xD;
          -  Sexually active or not.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or up to 6 months postpartum.&#xD;
&#xD;
          -  Current Urinary tract infection proved by urine analysis or urine culture.&#xD;
&#xD;
          -  Patient unfit for surgery.&#xD;
&#xD;
          -  Previous suspension operations.&#xD;
&#xD;
          -  Uncontrolled diabetic patients.&#xD;
&#xD;
          -  Urge incontinence.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Gamal M.fekry</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <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/NCT03772691
org study id: LSS
nct id: NCT03772691
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pelvic organ prolapse (POP) is considered one of the commonest gynecologic health problems
      all over the world. Pelvic organ prolapse (POP) is common and can be seen in up to 50% or
      more of parous women. The annual aggregated rate of associated surgery for pelvic organ
      prolapse is in the range of 10-30 per 10,000 women. It is estimated that women have an 11-19%
      life-time risk of undergoing surgery for POP. This rate is projected to increase over the
      next 2-3 decades. Apical POP refers any descent of the cervix or the vaginal cuff scar(as
      after hysterectomy) below a point which is 2 cm less than the total vaginal length about the
      plane of the hymen. Apical POP is due to defect in apical support with damage to the cardinal
      and uterosacral ligaments. Apical pelvic organ prolapse is a common issue in our country with
      significant incidence rate due to many predisposing factors including increasing age, higher
      gravidity and parity (especially the number of vaginal births)
By one estimate, the demand for health care services related to pelvic floor disorders will
      increase at twice the rate of the population itself . So we need adequate understanding of
      the best surgical method for treating apical POP which is accepted worldwide and also must be
      cost effective with least perioperative complications. Abdominal sacropexy is considered now
      the gold standard operation for treatment of apical pelvic organ prolapse. In this technique,
      the mesh is ﬁxed to the anterior longitudinal ligament at the sacral promontory. It is used
      either with uterine preservation (sacrohysteropexy) or after hysterectomy (sacrocolpopexy)
      for treatment of vault prolapse .However , many intraoperative complication can occur
      including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal
      injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative
      complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral
      osteomyelitis . Also, despite that sacropexy provide good apical support, but the high
      prevalence of cystocele and urinary tract symptoms in patients reaches up to 8% .
      Consequently, it is not surprising that the majority of failures following sacrocolpopexy
      occur in the anterior compartment. Lateral suspension with mesh was ﬁrst reported by
      Dubuisson in 1998 for the treatment of pelvic organ prolapse . The lateral suspension avoids
      both the risk of vascular injury and nerve damage of sacrocolpopexy with success rate up to
      88% of cases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: rate of occurance of denovo stress urinary incontinence
time frame: 18 months
description: number of patients developed new onset postoperative stress urinary incontinence
measure: The rate of Improvement of urinary symptoms
time frame: 18 months
description: Improvement of symptoms using Abramsc Development and psychometric evaluation of the International consultation on incontinence and Vaginal Symptoms Questionnaire maximum score:178, minimum score:0 high score means better outcome , low score means worse outcome
measure: objective assessment of prolapse stage
time frame: 18 months
description: improvement of POP-Q system postoperatively
measure: assessment of sexual function
time frame: 18 months
description: improvement of female sexual function index postoperatively
arm group label: lateral suspension
arm group type: Experimental
description: All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina
arm group label: sacropexy
arm group type: Active Comparator
description: Our ﬁrst passage is the peritoneum incision overlying the sacral promontory (L5-S1) to expose the anterior longitudinal ligament, which is the anchorage point of the mesh on the sacrum. We create a tunnel under the peritoneum on the right side through the cul-de-sac of Douglas till reach the cervix or vaginal cuff (after hysterectomy).
intervention type: Procedure
intervention name: lateral suspension
description: • The vesico-vaginal space was found between the bladder and the anterior vaginal wall in the fascia plane. A polypropylene mesh (25 , 25 cm, Ethicon, Inc., Somerville, NJ) was cut to obtain two long arms (15-20 mm wide) and a rectangular piece (4-7 cm wide).
arm group label: lateral suspension
intervention type: Procedure
intervention name: sacropexy
description: • The mesh is fixed on the anterior longitudinal ligament of sacrum with separated number 1 prolene sutures. The other end of the mesh is passed through the peritoneal tunnel and fixed to the cervix using prolene 1 and vicryl o sutures.
arm group label: sacropexy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Gamal M.fekry
investigator title: Principal investigator
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse