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
Overview
- Phase
- Phase 1
- Intervention
- Dried Cranberry
- Conditions
- Overactive Bladder
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Mean change in number of micturitions per day from baseline until end of treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ambulatory female subject ≥ 18 years of age and able to use the toilet without difficulty
- •OAB symptoms for ≥ 6 months
- •Frequency of micturition ≥ 8 times per 24 hr and ≥ 3 episodes of urgency (grade 3 or 4) without incontinence during the 3-day micturition diary period at baseline
- •Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- •Speak English and are able to understand the nature of the study
- •Able to give signed written informed consent
- •Signed informed consent form
Exclusion Criteria
- •Significant bladder outflow obstruction
- •Urinary Incontinence (defined as greater than 3 incontinence episodes in the month prior to screening)
- •Catheterization (indwelling catheter)
- •Diabetic neuropathy and unstable diabetes mellitus
- •Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months
- •Urethral diverticulum
- •Neurogenic bladder
- •Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome)
- •Bladder stones
- •History of carcinoma of the urinary tract
Arms & Interventions
Cranberry
500mg Dried Cranberry
Intervention: Dried Cranberry
Placebo Oral Capsule
Color Matching Placebo
Intervention: Placebo Oral Capsule
Outcomes
Primary Outcomes
Mean change in number of micturitions per day from baseline until end of treatment
Time Frame: 6 Months
Secondary Outcomes
- Change in number of urgency and frequency episodes per 24 hours from baseline until end of treatment(6 Months)
- Change in number of micturitions occuring during the night from baseline until end of treatment(6 Months)
- Change in overactive bladder questionnaire short form (OABQ-SF) score(6 Months)
- Change in Pelvic Floor Distress Inventory (PFDI-20)(6 Months)
- Change in patient perception of bladder condition (PPBC) score(6 Months)
- Change in Sexual Quality of Life-Female (SQOL-F) score(6 Months)