<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/NCT03017170</url>
  </required_header>
  <id_info>
    <org_study_id>1506016303</org_study_id>
    <nct_id>NCT03017170</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Dried Cranberry Powder in Women With Dry OAB</brief_title>
  <official_title>A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy of Dried Cranberry at 500 mg Daily in Women With Dry Overactive Bladder for 6 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Naturex-Dbs</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double-blind, placebo controlled study to evaluate the efficacy of dried&#xD;
      cranberry at 500 mg daily in women with overactive bladder for 6-months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 6 month, randomized, prospective, single-center trial that will be conducted in an&#xD;
      outpatient setting at a tertiary care facility. This will be a double-blind, randomized,&#xD;
      placebo-controlled parallel study of dried cranberry for OAB symptoms in women. Eligible&#xD;
      subjects will be female outpatients aged ≥18 years who have been diagnosed with OAB. All&#xD;
      patients will be provided written informed consent before entering the study. The study&#xD;
      protocol and all amendments will be approved by the appropriate Institutional Review Board.&#xD;
      Patients will be recruited for the study from the office of Dr. Bilal Chughtai, from within&#xD;
      Weill Cornell Medical College, including referral by WCMC-affiliated primary care and other&#xD;
      physicians not involved with the study, as well as recruited from advertisement (Craigslist,&#xD;
      newspapers, posters, etc.). Recruitment will also take place within New York Presbyterian&#xD;
      Hospital.&#xD;
&#xD;
      Subjects will have a complete history and physical examination in the office; the&#xD;
      participants will complete the validated questionnaires and informed consent, as well as&#xD;
      urinalysis. Eligible participants will be enrolled in the study and randomized to receive&#xD;
      either a dried cranberry or placebo. The primary endpoint is the mean change in number of&#xD;
      voids per day as measured using a three-day voiding diaries from baseline to&#xD;
      end-of-treatment. Patients will complete voiding diaries for 3 consecutive days prior to each&#xD;
      clinic visit. Secondary endpoints will include a comparison of the patient's baseline OAB&#xD;
      symptom bother and quality of life, and sexual function as measured by 4 validated&#xD;
      questionnaires: the OABQ-SF, PPBC, SQOL-F, and PFDI-20.&#xD;
&#xD;
      The subjects will be given a device to measure their urinary volume throughout the study.&#xD;
&#xD;
      The study duration will be 6 months. Follow-up visits will be conducted at 12 and 24 weeks.&#xD;
      Adverse reactions and complications will be obtained and recorded by Clavien-Dindo Grading&#xD;
      System.&#xD;
&#xD;
      The investigator seeks to determine if dried cranberry powder changes the microbiome of women&#xD;
      with Overactive Bladder symptoms versus placebo. At visit two (baseline) and visit four (end&#xD;
      of study visit) stool and urine samples will be collected from up to 40 study participants&#xD;
      out of the 76 participants enrolled in the study. The stool and urine samples will be&#xD;
      collected and the microbiome of each specimen will be analyzed by Genomics Core or&#xD;
      Epigenomics Core at Weill Cornell Medical College.&#xD;
&#xD;
      Participants in the study will provide urine samples. The urine sample will be collected in&#xD;
      sterile containers. Participants in the study will provide one urine sample during visit 2&#xD;
      (Baseline visit) and another sample during visit 4 (end of study). These samples will be&#xD;
      subsequently analyzed for the presence/ absence of microbiota. This includes DNA extraction,&#xD;
      library preparation, shotgun next-generation sequencing, and follow-up metagenomics and&#xD;
      microbiome analysis using bioinformatics alignment tools, in order to identify microbial&#xD;
      species and strains. Participants in the study will provide one stool sample during visit 2&#xD;
      of the study and another during visit 4 of the study. Stool samples will be self-collected&#xD;
      using a clean catching receptacle (e.g. plastic inverted hat) and plastic scoop to transfer&#xD;
      feces into 6 sterile tubes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>Phase 1</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in number of micturitions per day from baseline until end of treatment</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in number of urgency and frequency episodes per 24 hours from baseline until end of treatment</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of micturitions occuring during the night from baseline until end of treatment</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overactive bladder questionnaire short form (OABQ-SF) score</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient perception of bladder condition (PPBC) score</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sexual Quality of Life-Female (SQOL-F) score</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pelvic Floor Distress Inventory (PFDI-20)</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Cranberry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500mg Dried Cranberry</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Color Matching Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dried Cranberry</intervention_name>
    <description>Dried cranberry powder is not an &quot;extract&quot; of cranberries, but a &quot;full spectrum&quot; ingredient. It is comprised of a proprietary ratio of dried cranberry fruit, cranberry pomace, and cranberry seeds, each of which is a recognized food and/or dietary ingredient. One 500 mg capsule of dried cranberry powder consists of approximately 25 grams of cranberry fruit.</description>
    <arm_group_label>Cranberry</arm_group_label>
    <other_name>Cranberry</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>Colored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors</description>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ambulatory female subject ≥ 18 years of age and able to use the toilet without&#xD;
             difficulty&#xD;
&#xD;
          -  OAB symptoms for ≥ 6 months&#xD;
&#xD;
          -  Frequency of micturition ≥ 8 times per 24 hr and ≥ 3 episodes of urgency (grade 3 or&#xD;
             4) without incontinence during the 3-day micturition diary period at baseline&#xD;
&#xD;
          -  Subjects are willing to maintain their normal eating/drinking habits and exercise&#xD;
             habits to avoid changes in body weight over the duration of the study&#xD;
&#xD;
          -  Speak English and are able to understand the nature of the study&#xD;
&#xD;
          -  Able to give signed written informed consent&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant bladder outflow obstruction&#xD;
&#xD;
          -  Urinary Incontinence (defined as greater than 3 incontinence episodes in the month&#xD;
             prior to screening)&#xD;
&#xD;
          -  Catheterization (indwelling catheter)&#xD;
&#xD;
          -  Diabetic neuropathy and unstable diabetes mellitus&#xD;
&#xD;
          -  Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in&#xD;
             the previous 12 months&#xD;
&#xD;
          -  Urethral diverticulum&#xD;
&#xD;
          -  Neurogenic bladder&#xD;
&#xD;
          -  Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome,&#xD;
             painful bladder syndrome)&#xD;
&#xD;
          -  Bladder stones&#xD;
&#xD;
          -  History of carcinoma of the urinary tract&#xD;
&#xD;
          -  Lower urinary tract surgery in the last 6 months&#xD;
&#xD;
          -  Abnormal baseline urinalysis&#xD;
&#xD;
          -  Previous pelvic radiation therapy or previous, current malignant disease of the pelvic&#xD;
             organs or has received intravesical injection or electrostimluation in the past 12&#xD;
             months&#xD;
&#xD;
          -  Planning to undergo urologic procedures for which mucosal bleeding is anticipated&#xD;
&#xD;
          -  Drug or Nondrug treatments of OAB (in the previous 56 days), Concomitant medications&#xD;
             that affect detrusor activity&#xD;
&#xD;
          -  Cerebrovascular diseases&#xD;
&#xD;
          -  Neurological impairment or psychiatric disorder preventing appropriate understanding&#xD;
             of consent and ability to comply with site personnel instructions&#xD;
&#xD;
          -  History of drug or alcohol abuse within the last 12 months.&#xD;
&#xD;
          -  Has participated in a study involving the administration of an investigational agent&#xD;
             within the past 30 days, or within six half-lives of the prior investigational agent,&#xD;
             whichever is longer.&#xD;
&#xD;
          -  Subjects on Warfarin&#xD;
&#xD;
          -  Females of childbearing potential who are pregnant or planning to become pregnant&#xD;
             during the course of the study or breast-feeding&#xD;
&#xD;
          -  Subjects with history of kidneys stones&#xD;
&#xD;
          -  Treatable condition that could cause urinary incontinence or urgency&#xD;
&#xD;
          -  Planning to undergo urologic procedures for which mucosal bleeding is anticipated&#xD;
&#xD;
          -  Previous allergic conditions to cranberry products&#xD;
&#xD;
          -  Gastrointestinal obstruction or retention or fecal impaction&#xD;
&#xD;
          -  Failure to complete baseline 3-day diary&#xD;
&#xD;
          -  Subjects unable to swallow the capsule of the intervention&#xD;
&#xD;
          -  Subjects with gross hematuria&#xD;
&#xD;
          -  Judged by the investigator to be unsuitable for enrollment in this study for any&#xD;
             reason&#xD;
&#xD;
          -  Allergy or sensitivity to aspirin&#xD;
&#xD;
          -  Aspirin dose &gt; 81 mg&#xD;
&#xD;
          -  Subjects taking other prescription anti-platelet agents (e.g. clopidogrel,&#xD;
             ticlopidine, prasugrel, and ticagrelor)&#xD;
&#xD;
          -  Subject has moderate to severe hepatic impairment (Child-Pugh class B or C)&#xD;
&#xD;
          -  Subject has severe renal impairment defined as eGFR&lt;30 mL/min/1.73 m2)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bilal Chughtai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>September 14, 2018</last_update_submitted>
  <last_update_submitted_qc>September 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</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/NCT03017170
org study id: 1506016303
nct id: NCT03017170
lead sponsor: 
collaborator: 
has dmc: No
A randomized, double-blind, placebo controlled study to evaluate the efficacy of dried
      cranberry at 500 mg daily in women with overactive bladder for 6-months.
This is a 6 month, randomized, prospective, single-center trial that will be conducted in an
      outpatient setting at a tertiary care facility. This will be a double-blind, randomized,
      placebo-controlled parallel study of dried cranberry for OAB symptoms in women. Eligible
      subjects will be female outpatients aged ≥18 years who have been diagnosed with OAB. All
      patients will be provided written informed consent before entering the study. The study
      protocol and all amendments will be approved by the appropriate Institutional Review Board.
      Patients will be recruited for the study from the office of Dr. Bilal Chughtai, from within
      Weill Cornell Medical College, including referral by WCMC-affiliated primary care and other
      physicians not involved with the study, as well as recruited from advertisement (Craigslist,
      newspapers, posters, etc.). Recruitment will also take place within New York Presbyterian
      Hospital.

      Subjects will have a complete history and physical examination in the office; the
      participants will complete the validated questionnaires and informed consent, as well as
      urinalysis. Eligible participants will be enrolled in the study and randomized to receive
      either a dried cranberry or placebo. The primary endpoint is the mean change in number of
      voids per day as measured using a three-day voiding diaries from baseline to
      end-of-treatment. Patients will complete voiding diaries for 3 consecutive days prior to each
      clinic visit. Secondary endpoints will include a comparison of the patient's baseline OAB
      symptom bother and quality of life, and sexual function as measured by 4 validated
      questionnaires: the OABQ-SF, PPBC, SQOL-F, and PFDI-20.

      The subjects will be given a device to measure their urinary volume throughout the study.

      The study duration will be 6 months. Follow-up visits will be conducted at 12 and 24 weeks.
      Adverse reactions and complications will be obtained and recorded by Clavien-Dindo Grading
      System.

      The investigator seeks to determine if dried cranberry powder changes the microbiome of women
      with Overactive Bladder symptoms versus placebo. At visit two (baseline) and visit four (end
      of study visit) stool and urine samples will be collected from up to 40 study participants
      out of the 76 participants enrolled in the study. The stool and urine samples will be
      collected and the microbiome of each specimen will be analyzed by Genomics Core or
      Epigenomics Core at Weill Cornell Medical College.

      Participants in the study will provide urine samples. The urine sample will be collected in
      sterile containers. Participants in the study will provide one urine sample during visit 2
      (Baseline visit) and another sample during visit 4 (end of study). These samples will be
      subsequently analyzed for the presence/ absence of microbiota. This includes DNA extraction,
      library preparation, shotgun next-generation sequencing, and follow-up metagenomics and
      microbiome analysis using bioinformatics alignment tools, in order to identify microbial
      species and strains. Participants in the study will provide one stool sample during visit 2
      of the study and another during visit 4 of the study. Stool samples will be self-collected
      using a clean catching receptacle (e.g. plastic inverted hat) and plastic scoop to transfer
      feces into 6 sterile tubes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change in number of micturitions per day from baseline until end of treatment
time frame: 6 Months
measure: Change in number of urgency and frequency episodes per 24 hours from baseline until end of treatment
time frame: 6 Months
measure: Change in number of micturitions occuring during the night from baseline until end of treatment
time frame: 6 Months
measure: Change in overactive bladder questionnaire short form (OABQ-SF) score
time frame: 6 Months
measure: Change in patient perception of bladder condition (PPBC) score
time frame: 6 Months
measure: Change in Sexual Quality of Life-Female (SQOL-F) score
time frame: 6 Months
measure: Change in Pelvic Floor Distress Inventory (PFDI-20)
time frame: 6 Months
arm group label: Cranberry
arm group type: Experimental
description: 500mg Dried Cranberry
arm group label: Placebo Oral Capsule
arm group type: Placebo Comparator
description: Color Matching Placebo
intervention type: Drug
intervention name: Dried Cranberry
description: Dried cranberry powder is not an "extract" of cranberries, but a "full spectrum" ingredient. It is comprised of a proprietary ratio of dried cranberry fruit, cranberry pomace, and cranberry seeds, each of which is a recognized food and/or dietary ingredient. One 500 mg capsule of dried cranberry powder consists of approximately 25 grams of cranberry fruit.
arm group label: Cranberry
other name: Cranberry
intervention type: Drug
intervention name: Placebo Oral Capsule
description: Colored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors
arm group label: Placebo Oral Capsule
other name: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bilal Chughtai, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
sharing ipd: No