Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks
NCT ID: NCT05557279
Last Updated: 2025-09-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-01-01
Study Completion Date
2025-12-01
Brief Summary
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The purpose of this study is to learn about how the use of 500 mg of dried cranberry powder extract (NDS-446) changes the bacteria that normal reside in the bladder of women who don't have urinary leakage problems but do have problems with urinary urgency and frequency.
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Detailed Description
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While this treatment algorithm is the recommended approach to OAB management, recent research has resulted in the development of a new paradigm that may influence how this condition is treated in the future. This research focuses on the urinary microbiome and for a decade it has been known that urine is not sterile. Expanded Quantitative Urine Culture (EQUC) techniques have allowed for more comprehensive and accurate 16S ribosomal RNA sequencing of the urinary microbiome. Changes in the abundance and diversity of the resident microbiota have been associated with a number of urogenital conditions including interstitial cystitis, urinary incontinence, responses to OAB medications and symptoms of urinary tract infections. These studies provide insight to the fact that the microbiome plays an important role in the maintenance of a healthy urogenital tract. Thus, treatments that target the microbiome for one condition may work for others by similar mechanisms, especially when there is considerable symptom overlap between the two conditions as there is in UTIs and OAB.
One such treatment is cranberry (Vaccinium macrocarpon) extract, which has long been used as complementary therapy for a variety of medical conditions. Health benefits are linked to the presence of phytochemicals present in the fruit- anthocyanins, flavonols, tannins, proanthocyanidins, and phenolic acid derivatives. Cranberry is known to be effective in the prevention of UTIs. In a recent study examining its use in women with dry OAB, daily dried cranberry improved urgency symptoms and number of daytime voids. In addition, the authors reported an improvement in the validated subjective instrument, Patient Perception of Bladder Condition (PPBC). Moderately symptomatic LUTS in men improved following 6 months of daily dried cranberry powder. Therefore, the investigators aim to investigate changes to the female urinary microbiome in women with dry OAB who take daily dried cranberry extract. This study aims to quantify a change in urinary frequency, urinary urgency, and PPBC following the daily use of a cranberry extract called NDS-446. The investigators also have an ancillary hypothesis that women who are post-menopausal will develop a urinary microbiome more similar to pre-menopausal women by the end of the study. Lastly, the investigators will measure the levels of extracellular (eATP) in the urine of participants. It has been previously shown that higher levels of eATP are associated with worsening OAB symptoms.
One such treatment is cranberry (Vaccinium macrocarpon) extract, which has long been used as complementary therapy for a variety of medical conditions. Health benefits are linked to the presence of phytochemicals present in the fruit- anthocyanins, flavonols, tannins, proanthocyanidins, and phenolic acid derivatives. Cranberry is known to be effective in the prevention of UTIs. In a recent study examining its use in women with dry OAB, daily dried cranberry improved urgency symptoms and number of daytime voids. In addition, the authors reported an improvement in the validated subjective instrument, Patient Perception of Bladder Condition (PPBC). Moderately symptomatic LUTS in men improved following 6 months of daily dried cranberry powder. Therefore, the investigators aim to investigate changes to the female urinary microbiome in women with dry OAB who take daily dried cranberry extract. This study aims to quantify a change in urinary frequency, urinary urgency, and PPBC following the daily use of a cranberry extract called NDS-446. The investigators also have an ancillary hypothesis that women who are post-menopausal will develop a urinary microbiome more similar to pre-menopausal women by the end of the study. Lastly, the investigators will measure the levels of extracellular (eATP) in the urine of participants. It has been previously shown that higher levels of eATP are associated with worsening OAB symptoms.
Conditions
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Overactive Bladder
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment and meeting inclusion/exclusion criteria 20 premenopausal women, 20 postmenopausal women not on estrogen supplementation
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Intervention Group
All participants will receive 500 mg NDS-446 daily for 12 weeks
Group Type
OTHER
500 mg NDS-446
Intervention Type
DRUG
All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment
Interventions
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500 mg NDS-446
All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 18 years, female, ambulatory
* OAB symptoms \> 6 months
* Voiding frequency \> 8 times in 24 hrs and \> 3 episodes of urgency (grade 3 or 4) without incontinence during 3-day diary at baseline
* OAB symptoms \> 6 months
* Voiding frequency \> 8 times in 24 hrs and \> 3 episodes of urgency (grade 3 or 4) without incontinence during 3-day diary at baseline
Exclusion Criteria
* Self-reported urinary incontinence (\> 3 episodes in the month prior)
* UTI \> 3 in last 12 months
* A diagnosis of painful bladder syndrome or interstitial cystitis
* LUT surgery last 6 months
* Drug or non-drug treatment of OAB (previous 60 days) or current meds that affect detrusor activity
* On Warfarin
* Failure to complete 3-day diary
* Aspirin \> 81 mg daily
* Gross hematuria
* Allergy or sensitivity to aspirin
* Subjects taking anti-platelet agents
* Inability to swallow capsules
* UTI \> 3 in last 12 months
* A diagnosis of painful bladder syndrome or interstitial cystitis
* LUT surgery last 6 months
* Drug or non-drug treatment of OAB (previous 60 days) or current meds that affect detrusor activity
* On Warfarin
* Failure to complete 3-day diary
* Aspirin \> 81 mg daily
* Gross hematuria
* Allergy or sensitivity to aspirin
* Subjects taking anti-platelet agents
* Inability to swallow capsules
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Loyola University
OTHER
Sponsor Role
lead
Responsible Party
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Elizabeth Mueller MD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Elizabeth Mueller, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola Medical Center
Locations
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Loyola Medical Center
Maywood, Illinois, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Wolfe AJ, Toh E, Shibata N, Rong R, Kenton K, Fitzgerald M, Mueller ER, Schreckenberger P, Dong Q, Nelson DE, Brubaker L. Evidence of uncultivated bacteria in the adult female bladder. J Clin Microbiol. 2012 Apr;50(4):1376-83. doi: 10.1128/JCM.05852-11. Epub 2012 Jan 25.
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Price TK, Dune T, Hilt EE, Thomas-White KJ, Kliethermes S, Brincat C, Brubaker L, Wolfe AJ, Mueller ER, Schreckenberger PC. The Clinical Urine Culture: Enhanced Techniques Improve Detection of Clinically Relevant Microorganisms. J Clin Microbiol. 2016 May;54(5):1216-22. doi: 10.1128/JCM.00044-16. Epub 2016 Mar 9.
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Burnett LA, Hochstedler BR, Weldon K, Wolfe AJ, Brubaker L. Recurrent urinary tract infection: Association of clinical profiles with urobiome composition in women. Neurourol Urodyn. 2021 Aug;40(6):1479-1489. doi: 10.1002/nau.24707. Epub 2021 May 26.
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Cho A, Eidelberg A, Butler DJ, Danko D, Afshinnekoo E, Mason CE, Chughtai B. Efficacy of Daily Intake of Dried Cranberry 500 mg in Women with Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled Study. J Urol. 2021 Feb;205(2):507-513. doi: 10.1097/JU.0000000000001384. Epub 2020 Sep 18.
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Vidlar A, Student V Jr, Vostalova J, Fromentin E, Roller M, Simanek V, Student V. Cranberry fruit powder (Flowens) improves lower urinary tract symptoms in men: a double-blind, randomized, placebo-controlled study. World J Urol. 2016 Mar;34(3):419-24. doi: 10.1007/s00345-015-1611-7. Epub 2015 Jun 7.
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Vidlar A, Vostalova J, Ulrichova J, Student V, Stejskal D, Reichenbach R, Vrbkova J, Ruzicka F, Simanek V. The effectiveness of dried cranberries ( Vaccinium macrocarpon) in men with lower urinary tract symptoms. Br J Nutr. 2010 Oct;104(8):1181-9. doi: 10.1017/S0007114510002059. Epub 2010 Aug 31.
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Thomas-White K, Taege S, Limeira R, Brincat C, Joyce C, Hilt EE, Mac-Daniel L, Radek KA, Brubaker L, Mueller ER, Wolfe AJ. Vaginal estrogen therapy is associated with increased Lactobacillus in the urine of postmenopausal women with overactive bladder symptoms. Am J Obstet Gynecol. 2020 Nov;223(5):727.e1-727.e11. doi: 10.1016/j.ajog.2020.08.006. Epub 2020 Aug 11.
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Other Identifiers
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215838
Identifier Type: -
Identifier Source: org_study_id
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