<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/NCT01691742</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00035126</org_study_id>
    <nct_id>NCT01691742</nct_id>
  </id_info>
  <brief_title>MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery</brief_title>
  <acronym>MVP</acronym>
  <official_title>Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Urogynecologic Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate&#xD;
      postoperative period following pelvic reconstructive surgery in women taking routine docusate&#xD;
      sodium.&#xD;
&#xD;
      B. Objectives&#xD;
&#xD;
        1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between&#xD;
           MiraLAX versus placebo in women receiving routine docusate sodium after pelvic&#xD;
           reconstructive surgery.&#xD;
&#xD;
           Specific Aim 2: To compare patient reported outcomes of BM quality and associated&#xD;
           gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool&#xD;
           scale and the validated Patient Assessment of Constipation Symptom Questionnaire&#xD;
           (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive&#xD;
           surgery.&#xD;
&#xD;
           Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo&#xD;
           utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire&#xD;
           (PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive&#xD;
           surgery.&#xD;
&#xD;
        2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent&#xD;
           constipation following pelvic reconstructive surgery by decreasing time to first BM,&#xD;
           decreasing GI symptoms associated with constipation, and increasing measures of&#xD;
           GI-related quality of life, while minimizing the bothersome side effects associated with&#xD;
           stimulant laxatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized double-blind placebo-controlled clinical trial of MiraLAX versus placebo&#xD;
      in women undergoing pelvic reconstructive surgery receiving routine docusate sodium. Subjects&#xD;
      will be screened for eligibility during their preoperative visits and once enrolled, they&#xD;
      will be randomized to receive MiraLAX or placebo starting on postoperative day (POD) 1 and&#xD;
      continuing through POD 5. Subjects will be instructed to stop taking this medication if they&#xD;
      experience any diarrhea. Subjects in both arms will be instructed to take milk of magnesia as&#xD;
      a rescue laxative if they do not experience a BM by the morning of POD 6. All subjects will&#xD;
      be provided a 30 day supply of docusate sodium and be instructed to begin this medication on&#xD;
      POD 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first postoperative bowel movement</measure>
    <time_frame>First postoperative week</time_frame>
    <description>The primary outcome is time to first postoperative bowel movement (in hours, converted to days) based upon postoperative bowel diary. Time will be calculated based upon date and time of first postoperative bowel movement from start time of surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other postoperative medication use</measure>
    <time_frame>First postoperative week</time_frame>
    <description>Rescue laxative use, daily pain level and narcotic use will be obtained from postoperative bowel diaries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of symptoms and quality of life related to constipation</measure>
    <time_frame>First postoperative week</time_frame>
    <description>The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Over-Effectiveness</measure>
    <time_frame>First Postoperative Week</time_frame>
    <description>Symptoms of over-effectiveness, including abdominal pain or cramping, bloating, loose stools, watery diarrhea and their impact on GI-related quality of life will be evaluated based upon bowel diaries, Bristol stool scales and the PAC-SYM and PAC-QOL questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively</measure>
    <time_frame>5-7 weeks postoperatively</time_frame>
    <description>The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Post Procedural Constipation</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MiraLax</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MiraLax</intervention_name>
    <description>MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery</description>
    <arm_group_label>MiraLax</arm_group_label>
    <other_name>PEG 3350</other_name>
    <other_name>Polyethylene Glycol 3350</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Maltodextrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rescue Laxative</intervention_name>
    <description>All participants will be instructed to take Milk of Magnesia with standard over-the-counter dosing as a recue laxative if the subject has not had a bowel movement by postoperative day 6.</description>
    <arm_group_label>MiraLax</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Milk of Magnesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking female patients&#xD;
&#xD;
          -  &gt; 18 years of age&#xD;
&#xD;
          -  Not pregnant (patients of childbearing potential will have a serum pregnancy test done&#xD;
             pre-operatively as part of their surgical planning)&#xD;
&#xD;
          -  Undergoing surgery for pelvic organ prolapse or stress urinary incontinence&#xD;
&#xD;
          -  Recruited from the Duke University Division of Urogynecology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy/hypersensitivity to study medications&#xD;
&#xD;
          -  Cardiac or renal disease&#xD;
&#xD;
          -  Takes chronic daily laxatives&#xD;
&#xD;
          -  Excluded if unable to complete at least 5 days of a 7 day baseline bowel diary&#xD;
&#xD;
          -  Excluded if mesh resection or Interstim procedure&#xD;
&#xD;
          -  Excluded if concurrent surgery includes anal sphincteroplasty or rectovaginal fistula&#xD;
             repair&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony G Visco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University, Department of Urogynecology</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postoperative constipation</keyword>
  <keyword>Urogynecologic Surgery</keyword>
  <keyword>MiraLax</keyword>
  <keyword>Docusate Sodium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyethylene glycol 3350</mesh_term>
    <mesh_term>Laxatives</mesh_term>
  </intervention_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/NCT01691742
org study id: Pro00035126
nct id: NCT01691742
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate
      postoperative period following pelvic reconstructive surgery in women taking routine docusate
      sodium.

      B. Objectives

        1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between
           MiraLAX versus placebo in women receiving routine docusate sodium after pelvic
           reconstructive surgery.

           Specific Aim 2: To compare patient reported outcomes of BM quality and associated
           gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool
           scale and the validated Patient Assessment of Constipation Symptom Questionnaire
           (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive
           surgery.

           Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo
           utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire
           (PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive
           surgery.

        2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent
           constipation following pelvic reconstructive surgery by decreasing time to first BM,
           decreasing GI symptoms associated with constipation, and increasing measures of
           GI-related quality of life, while minimizing the bothersome side effects associated with
           stimulant laxatives.
This is a randomized double-blind placebo-controlled clinical trial of MiraLAX versus placebo
      in women undergoing pelvic reconstructive surgery receiving routine docusate sodium. Subjects
      will be screened for eligibility during their preoperative visits and once enrolled, they
      will be randomized to receive MiraLAX or placebo starting on postoperative day (POD) 1 and
      continuing through POD 5. Subjects will be instructed to stop taking this medication if they
      experience any diarrhea. Subjects in both arms will be instructed to take milk of magnesia as
      a rescue laxative if they do not experience a BM by the morning of POD 6. All subjects will
      be provided a 30 day supply of docusate sodium and be instructed to begin this medication on
      POD 1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to first postoperative bowel movement
time frame: First postoperative week
description: The primary outcome is time to first postoperative bowel movement (in hours, converted to days) based upon postoperative bowel diary. Time will be calculated based upon date and time of first postoperative bowel movement from start time of surgery.
measure: Other postoperative medication use
time frame: First postoperative week
description: Rescue laxative use, daily pain level and narcotic use will be obtained from postoperative bowel diaries.
measure: Evaluation of symptoms and quality of life related to constipation
time frame: First postoperative week
description: The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM.
measure: Symptoms of Over-Effectiveness
time frame: First Postoperative Week
description: Symptoms of over-effectiveness, including abdominal pain or cramping, bloating, loose stools, watery diarrhea and their impact on GI-related quality of life will be evaluated based upon bowel diaries, Bristol stool scales and the PAC-SYM and PAC-QOL questionnaires.
measure: Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively
time frame: 5-7 weeks postoperatively
description: The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
arm group label: MiraLax
arm group type: Active Comparator
description: MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
intervention type: Drug
intervention name: MiraLax
description: MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
arm group label: MiraLax
other name: PEG 3350
other name: Polyethylene Glycol 3350
intervention type: Drug
intervention name: Placebo
description: Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
arm group label: Placebo
other name: Maltodextrin
intervention type: Drug
intervention name: Rescue Laxative
description: All participants will be instructed to take Milk of Magnesia with standard over-the-counter dosing as a recue laxative if the subject has not had a bowel movement by postoperative day 6.
arm group label: MiraLax
arm group label: Placebo
other name: Milk of Magnesia
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony G Visco, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Constipation
mesh term: Polyethylene glycol 3350
mesh term: Laxatives