Overactive BladderPhase 1NCT03017170
Evaluation of the Effect of Dried Cranberry Powder in Women With Dry OAB
A Phase 1 study testing Dried Cranberry in people with Overactive Bladder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Dried Cranberry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 35Show fewer
- Neurogenic bladder
- Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome)
- Bladder stones
- History of carcinoma of the urinary tract
- Lower urinary tract surgery in the last 6 months
- Abnormal baseline urinalysis
- Previous pelvic radiation therapy or previous, current malignant disease of the pelvic organs or has received intravesical injection or electrostimluation in the past 12 months
- Planning to undergo urologic procedures for which mucosal bleeding is anticipated
- Drug or Nondrug treatments of OAB (in the previous 56 days), Concomitant medications that affect detrusor activity
- Cerebrovascular diseases
- Neurological impairment or psychiatric disorder preventing appropriate understanding of consent and ability to comply with site personnel instructions
- History of drug or alcohol abuse within the last 12 months.
- Has participated in a study involving the administration of an investigational agent within the past 30 days, or within six half-lives of the prior investigational agent, whichever is longer.
- Subjects on Warfarin
- Females of childbearing potential who are pregnant or planning to become pregnant during the course of the study or breast-feeding
- Subjects with history of kidneys stones
- Treatable condition that could cause urinary incontinence or urgency
- Planning to undergo urologic procedures for which mucosal bleeding is anticipated
- Previous allergic conditions to cranberry products
- Gastrointestinal obstruction or retention or fecal impaction
- Failure to complete baseline 3-day diary
- Subjects unable to swallow the capsule of the intervention
- Subjects with gross hematuria
- Judged by the investigator to be unsuitable for enrollment in this study for any reason
- Allergy or sensitivity to aspirin
- Aspirin dose > 81 mg
- Subjects taking other prescription anti-platelet agents (e.g. clopidogrel, ticlopidine, prasugrel, and ticagrelor)
- Subject has moderate to severe hepatic impairment (Child-Pugh class B or C)
- Subject has severe renal impairment defined as eGFR<30 mL/min/1.73 m2)
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Dried Cranberry, Placebo Oral Capsule
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried CranberryDrug
Also called 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.
Placebo Oral CapsuleDrug
Also called Placebo
Colored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors
| Study group | Role | What they receive |
|---|---|---|
| Cranberry | Experimental | 500mg Dried Cranberry Receives: Drug: Dried Cranberry |
| Placebo Oral Capsule | Placebo comparator | Color Matching Placebo Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in number of micturitions per day from baseline until end of treatment
Measured: 6 Months
Secondary outcomes (6)
Change in number of urgency and frequency episodes per 24 hours from baseline until end of treatment
Measured: 6 Months
Change in number of micturitions occuring during the night from baseline until end of treatment
Measured: 6 Months
Change in overactive bladder questionnaire short form (OABQ-SF) score
Measured: 6 Months
Change in patient perception of bladder condition (PPBC) score
Measured: 6 Months
Change in Sexual Quality of Life-Female (SQOL-F) score
Measured: 6 Months
Change in Pelvic Floor Distress Inventory (PFDI-20)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex-Dbs
- Responsible party
- Sponsor
- Investigators
- Bilal Chughtai, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017170
- Sponsor's protocol ID
- 1506016303
- Status last verified
- Sep 2018
- First submitted
- 22 Dec 2016
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03017170
- Acronym / sponsor ID
- 1506016303
- Conditions
- Overactive Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Naturex-Dbs
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry | Experimental | Drug: Dried Cranberry500mg Dried Cranberry |
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo Oral CapsuleColor Matching Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried CranberryAlso: CranberryDried 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. | Drug | Cranberry |
| Placebo Oral CapsuleAlso: PlaceboColored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors | Drug | Placebo Oral Capsule |
Primary outcome
Mean change in number of micturitions per day from baseline until end of treatment
Time frame: 6 Months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilal Chughtai, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dried Cranberry in people with Overactive Bladder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in number of micturitions per day from baseline until end of treatment (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.