Evaluation of the Effect of Dried Cranberry Powder in Women With Dry OAB
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dried Cranberry; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Colored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors
Other intervention name(s): Cranberry; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care