<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/NCT03295253</url>
  </required_header>
  <id_info>
    <org_study_id>212516</org_study_id>
    <nct_id>NCT03295253</nct_id>
  </id_info>
  <brief_title>Fat Grafting Technique Using Autologous Adipose Tissue Lipogems in Patients Suffering From Stress Urinary Incontinence</brief_title>
  <official_title>Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Miriam Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or&#xD;
      menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the&#xD;
      vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral&#xD;
      sphincter all result in stress incontinence, urge incontinence and sometimes mixed&#xD;
      incontinence respectively.&#xD;
&#xD;
      The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented&#xD;
      autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence.&#xD;
      This is a prospective study of 25 subjects that will be evaluated over a period of one year.&#xD;
&#xD;
      The treatment consist of the injection of micro fragmented adipose tissue, previously&#xD;
      extracted from the patient in the area of the urethral sphyncter.&#xD;
&#xD;
      Patients will have follow ups at 6 months with Urodynamic studies to measure the pre-post&#xD;
      injection differences to-date. Visual analog score questionnaire and report in subjective&#xD;
      improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or&#xD;
      menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the&#xD;
      vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral&#xD;
      sphincter all result in stress incontinence, urge incontinence and sometimes mixed&#xD;
      incontinence respectively. The purpose of this study is to evaluate reconstructive lipoplasty&#xD;
      with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with stress&#xD;
      urinary incontinence. This is a prospective study of 25 subjects that will be evaluated over&#xD;
      a period of one year.&#xD;
&#xD;
      Different available treatments for stress urinary incontinence (SUI) are surgical: MMK, R A&#xD;
      Z, Burch, (TOT, T VT-mesh sling) and urethral bulking agents. New treatments using&#xD;
      mesenchymal stem cells have been tested for the last eight years and now moved from animal&#xD;
      models to humans with positive results.&#xD;
&#xD;
      Subjects will receive a full history and examination by a single urologist. A clear history&#xD;
      of their incontinence pattern, the amount of incontinence based on PAD counts, under what&#xD;
      conditions incontinence occurs to categorize type of incontinence for the female patient pre-&#xD;
      or post-menopause. Childbirth history, age of onset, time of occurrence, predisposing&#xD;
      factors, medications, hormones, etc. all patients will be registered and categorized&#xD;
      according to incontinence.&#xD;
&#xD;
      The patients will receive reconstructive lipoplasty with micro-fragmented autologous adipose&#xD;
      tissue (Lipogems®).&#xD;
&#xD;
      Subjects will log their results immediately post injection and then daily for up to two years&#xD;
      noting any changes they've noticed in their presenting problems. At 6 months Urodynamic&#xD;
      studies will be performed to measure the pre-post injection differences to-date. Visual&#xD;
      analog score questionnaire and report in subjective improvement, pad use and stress cough&#xD;
      test will be documented at 1, 3, 6, and 12 months follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Anticipated">December 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of pre and post procedure patient reported outcomes questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of pre and post procedure patient Urodynamic studies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resolution of Stress urinary Incontinence Measured by patient reported pad count</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of pre and post procedure patient pad count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resolution of Stress urinary Incontinence Measured by patient cough stress test</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of pre and post procedure patient cough stress test</description>
  </primary_outcome>
  <other_outcome>
    <measure>Incidence of treatment related adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>site-reported adverse events designated as related to the treatment</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Urinary Incontinence,Stress</condition>
  <arm_group>
    <arm_group_label>Female patients with Stress Incontinence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous adipose tissue harvesting/grafting using Lipogems</intervention_name>
    <description>Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems</description>
    <arm_group_label>Female patients with Stress Incontinence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Female patients with:&#xD;
&#xD;
          1. stress incontinence (SUI)&#xD;
&#xD;
          2. mixed urinary incontinence (SUI main component)&#xD;
&#xD;
          3. Intrinsic Sphincter Deficiency (ISD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Present diagnosis of cancer (not in remission)&#xD;
&#xD;
          2. Patients with uncorrected vaginal prolapse (cystocele or utero/bladder prolapse)&#xD;
&#xD;
          3. Incontinence of unknown etiology (other medical reasons) overflow incontinence&#xD;
&#xD;
          4. Patients with neurogenic bladder&#xD;
&#xD;
          5. Any patients unable to give informed consent, including members of vulnerable&#xD;
             populations&#xD;
&#xD;
          6. Patients with concomitant pelvic floor disorders, like interstitial cystitis or pelvic&#xD;
             floor dysfunction&#xD;
&#xD;
          7. Vulvar dermatosis, herpes simplex or active or recurrent urinary tract infection&#xD;
&#xD;
          8. Patients with chronic steroid use&#xD;
&#xD;
          9. Patients 17 and under&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janice Santos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women Medicine Collaborative/The Miriam Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrizia Curran, MD</last_name>
    <role>Study Director</role>
    <affiliation>The Miriam Hospital/ Women Medicine Collaborative</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Janice Santos, MD</last_name>
    <phone>401-421-0710</phone>
    <phone_ext>1321</phone_ext>
    <email>janice.santos-cortes@lifespan.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrizia Curran, MD</last_name>
    <phone>401-793-7824</phone>
    <email>pcurran1@lifespan.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Miriam Hospital/ Women Medicine Collaborative</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janice Santos, MD</last_name>
      <phone>401-421-0710</phone>
      <phone_ext>1321</phone_ext>
      <email>janice.santos-cortes@lifespan.org</email>
    </contact>
    <contact_backup>
      <last_name>Patrizia Curran, MD</last_name>
      <phone>401-793-7824</phone>
      <email>pcurran1@lifespan.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Miriam Hospital</investigator_affiliation>
    <investigator_full_name>Janice Santos Cortes</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery (Urology)</investigator_title>
  </responsible_party>
  <keyword>urinary incontinence</keyword>
  <keyword>stress urinary incontinence</keyword>
  <keyword>stress incontinence</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>
  </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/NCT03295253
org study id: 212516
nct id: NCT03295253
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or
      menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the
      vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral
      sphincter all result in stress incontinence, urge incontinence and sometimes mixed
      incontinence respectively.

      The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented
      autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence.
      This is a prospective study of 25 subjects that will be evaluated over a period of one year.

      The treatment consist of the injection of micro fragmented adipose tissue, previously
      extracted from the patient in the area of the urethral sphyncter.

      Patients will have follow ups at 6 months with Urodynamic studies to measure the pre-post
      injection differences to-date. Visual analog score questionnaire and report in subjective
      improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months
      follow-up.
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or
      menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the
      vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral
      sphincter all result in stress incontinence, urge incontinence and sometimes mixed
      incontinence respectively. The purpose of this study is to evaluate reconstructive lipoplasty
      with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with stress
      urinary incontinence. This is a prospective study of 25 subjects that will be evaluated over
      a period of one year.

      Different available treatments for stress urinary incontinence (SUI) are surgical: MMK, R A
      Z, Burch, (TOT, T VT-mesh sling) and urethral bulking agents. New treatments using
      mesenchymal stem cells have been tested for the last eight years and now moved from animal
      models to humans with positive results.

      Subjects will receive a full history and examination by a single urologist. A clear history
      of their incontinence pattern, the amount of incontinence based on PAD counts, under what
      conditions incontinence occurs to categorize type of incontinence for the female patient pre-
      or post-menopause. Childbirth history, age of onset, time of occurrence, predisposing
      factors, medications, hormones, etc. all patients will be registered and categorized
      according to incontinence.

      The patients will receive reconstructive lipoplasty with micro-fragmented autologous adipose
      tissue (Lipogems®).

      Subjects will log their results immediately post injection and then daily for up to two years
      noting any changes they've noticed in their presenting problems. At 6 months Urodynamic
      studies will be performed to measure the pre-post injection differences to-date. Visual
      analog score questionnaire and report in subjective improvement, pad use and stress cough
      test will be documented at 1, 3, 6, and 12 months follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire
time frame: 2 years
description: Comparison of pre and post procedure patient reported outcomes questionnaire
measure: Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies
time frame: 2 years
description: Comparison of pre and post procedure patient Urodynamic studies
measure: Resolution of Stress urinary Incontinence Measured by patient reported pad count
time frame: 2 years
description: Comparison of pre and post procedure patient pad count
measure: Resolution of Stress urinary Incontinence Measured by patient cough stress test
time frame: 2 years
description: Comparison of pre and post procedure patient cough stress test
measure: Incidence of treatment related adverse events
time frame: 2 years
description: site-reported adverse events designated as related to the treatment
arm group label: Female patients with Stress Incontinence
arm group type: Experimental
description: Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck
intervention type: Procedure
intervention name: Autologous adipose tissue harvesting/grafting using Lipogems
description: Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems
arm group label: Female patients with Stress Incontinence
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janice Santos, MD
role: Principal Investigator
affiliation: Women Medicine Collaborative/The Miriam Hospital
last name: Patrizia Curran, MD
role: Study Director
affiliation: The Miriam Hospital/ Women Medicine Collaborative
last name: Janice Santos, MD
phone: 401-421-0710
phone ext: 1321
email: janice.santos-cortes@lifespan.org
last name: Patrizia Curran, MD
phone: 401-793-7824
email: pcurran1@lifespan.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Miriam Hospital
investigator full name: Janice Santos Cortes
investigator title: Assistant Professor of Surgery (Urology)
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No