Evaluation of the Effect of Dried Cranberry Powder in Women With Dry OAB
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|ClinicalTrials.gov Identifier: NCT03017170|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: Dried Cranberry Drug: Placebo Oral Capsule||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
500mg Dried Cranberry
Drug: Dried Cranberry
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.
Other Name: Cranberry
Placebo Comparator: Placebo Oral Capsule
Color Matching Placebo
Drug: Placebo Oral Capsule
Colored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors
Other Name: Placebo
- Mean change in number of micturitions per day from baseline until end of treatment [ Time Frame: 6 Months ]
- Change in number of urgency and frequency episodes per 24 hours from baseline until end of treatment [ Time Frame: 6 Months ]
- Change in number of micturitions occuring during the night from baseline until end of treatment [ Time Frame: 6 Months ]
- Change in overactive bladder questionnaire short form (OABQ-SF) score [ Time Frame: 6 Months ]
- Change in patient perception of bladder condition (PPBC) score [ Time Frame: 6 Months ]
- Change in Sexual Quality of Life-Female (SQOL-F) score [ Time Frame: 6 Months ]
- Change in Pelvic Floor Distress Inventory (PFDI-20) [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017170
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Bilal Chughtai, MD||Weill Medical College of Cornell University|