Cranberry Powder for Overactive Bladder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Loyola University
Must not be taking: Warfarin, Anti-platelet agents
Disqualifiers: Urinary incontinence, UTI, Painful bladder, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop taking certain medications. The trial excludes participants who are currently on medications that affect detrusor activity, are taking Warfarin, or are on anti-platelet agents. Additionally, you cannot take more than 81 mg of aspirin daily.
What data supports the idea that Cranberry Powder for Overactive Bladder is an effective treatment?
The available research does not provide any data on the effectiveness of Cranberry Powder for Overactive Bladder. Instead, it discusses other treatments like capsaicin, solifenacin, and imidafenacin, which have shown effectiveness in reducing symptoms of overactive bladder. For example, capsaicin treatment reduced the need to urinate and improved bladder capacity, while solifenacin and imidafenacin also showed significant improvements in symptoms. However, there is no specific data on Cranberry Powder in the provided information.12345
What safety data exists for cranberry powder used for overactive bladder?
The safety data for cranberry powder, including formulations like 500 mg NDS-446 and Dried Cranberry Powder Extract, indicates an optimal safety profile with no significant adverse events reported in studies. The European Food Safety Authority (EFSA) has evaluated cranberry extract powder as a novel food ingredient and found no safety concerns, concluding it is safe for use in foods at proposed levels. Additionally, a study on a standardized cranberry extract showed good tolerability with no drop-outs due to adverse effects.678910
Research Team
EM
Elizabeth Mueller, MD
Principal Investigator
Loyola Medical Center
Eligibility Criteria
This trial is for women over 18 with an overactive bladder (OAB) who have had symptoms like urinary urgency and frequency for more than six months. They must not have incontinence but do need to urinate often, more than eight times a day, and feel sudden urges to go. Women can't join if they've had lower urinary tract surgery recently, take certain medications like high-dose aspirin or Warfarin, have allergies to aspirin, trouble swallowing pills, frequent UTIs, painful bladder conditions or are on other OAB treatments.Inclusion Criteria
I am a woman, 18 or older, and can walk.
I use the bathroom more than 8 times a day and feel a strong urge to urinate more than 3 times without leaking.
I have had overactive bladder symptoms for over 6 months.
Exclusion Criteria
I have had more than 3 UTIs in the past year.
I have experienced urinary incontinence more than 3 times last month.
I have been treated for overactive bladder in the last 60 days or am on medication affecting bladder control.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 500 mg of NDS-446 daily to assess changes in urinary microbiome and symptoms of dry OAB
12 weeks
12 week visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- 500 mg NDS-446 (Other)
Trial OverviewThe study tests how a dried cranberry powder extract (500 mg NDS-446) affects the bladder's bacteria in women with dry OAB. It aims to see if this natural remedy changes the urinary microbiome after 12 weeks of use without causing leakage problems.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
All participants will receive 500 mg NDS-446 daily for 12 weeks
500 mg NDS-446 is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Cranberry Powder for:
- Prevention of Urinary Tract Infections (UTIs)
- Urinary Urgency and Frequency
🇨🇦 Approved in Canada as Cranberry Powder for:
- Prevention of Urinary Tract Infections (UTIs)
- Urinary Urgency and Frequency
🇪🇺 Approved in European Union as Cranberry Powder for:
- Prevention of Urinary Tract Infections (UTIs)
- Urinary Urgency and Frequency
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Loyola Medical CenterMaywood, IL
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Who Is Running the Clinical Trial?
Loyola University
Lead Sponsor
Trials
161
Patients Recruited
31,400+
References
A double-blind, randomized, placebo-controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan. [2021]This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration.
The efficacy of Thai capsaicin in management of overactive bladder and hypersensitive bladder. [2013]This paper has been generated to provide information on the effectiveness of capsaicin treatment among patients with overactive or hypersensitive bladder. The evaluation process required approximately 14 (overactive bladder) and 11 (hypersensitive bladder and primary detrusor instability) participants who received capsaicin intravesically. The solution consisted of capsaicin (concentration = 1 mM/L) diluted in 30 per cent ethanol solution 100 ml. All participants went through at least 1 urodynamic test 1 month before and after receiving capsaicin intravesical instillation. The capsaicin treatment for overactive and hypersensitive bladders was very effective. On the average, (overactive bladder) participants' voiding needs decreased from 16.5 +/- 4.8 times/day to 8.6 +/- 2.5 times/day, leakage from 9.7 +/- 8.1 times/day to 2.4 +/- 4.3 times/day, bladder capacity from 160.1 +/- 123.3 ml to 236.9 +/- 146.1 ml, and detrusor contraction from 71.1 +/- 29.2 cm/H2O to 57.3 +/- 27.2 cm/H2O. On average, (hypersensitive bladder and primary detrusor instability) participants' voiding needs decreased from (Day time) 19.45 +/- 17.99 times to 12.00 +/- 8.91 times/day, (Night time) 7.09 +/- 6.03 times to 4.09 +/- 3.8 times, bladder capacity from 197.40 +/- 156.06 ml to 323.45 +/- 129.46 ml, and detrusor contraction from 32.64 +/- 22.77 cm/H2O to 36.64 +/- 19.22 cm/H2O. Capsaicin efficiency was rated very high for both overactive and hypersensitive bladder and primary detrusor instability. In Thailand, it has been possible to produce capsaicin using local chili supplies, thus the price of the drug itself is very economical. When considering the efficiency and the inexpensive cost of capsaicin, this treatment would be another great alternative for overactive and hypersensitive bladder cure.
Overactive bladder symptom score to evaluate efficacy of solifenacin for the treatment of overactive bladder symptoms. [2015]Overactive bladder (OAB) is a series of symptoms with high prevalence in elderly people. This study was conducted using the overactive bladder symptom score (OABSS) to evaluate the efficacy of solifenacin succinate for the treatment of OAB.
Solifenacin significantly improves all symptoms of overactive bladder syndrome. [2022]Overactive bladder syndrome (OAB) is a chronic condition characterised by urgency, with or without associated urge incontinence. Solifenacin succinate is a once daily, bladder selective antimuscarinic available in two doses (5 and 10 mg). The recommended dose is 5 mg once daily and can be increased to 10 mg once daily if 5 mg is well tolerated. This article presents pooled efficacy and safety data from four large, placebo-controlled, multinational phase III trials of solifenacin succinate with a total enrolment of over 2800 patients. Data from these trials show that solifenacin 5 and 10 mg once daily is significantly more effective than placebo at reducing urgency, incontinence, micturition frequency and nocturia and at increasing volume voided per micturition. Adverse events were mainly mild-to-moderate in all treatment groups. The results of these phase III trials support the use of solifenacin in the treatment of OAB.
[Efficacy and safety of imidafenacin in female patients with urge and mixed urinary incontinence]. [2012]The effect of imidafenacin for the treatment of overactive bladder (OAB), in female patients with urge and mixed urinary incontinence was examined. Prior to administration and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after administration, symptoms and quality of life were assessed using the overactive bladder symptom score (OABSS) and the international consultation on incontinence questionnaire-short form (ICIQ-SF), respectively. After administration, OABSS and ICIQ-SF scores were improved significantly when compared to baseline values. The incidence of adverse events was 7. 9% and none were serious. Imidafenacin was effective in female patients with urge and mixed urinary incontinence. In addition, imidafenacin rapidly improved incontinence one week after administration.
Efficacy of Daily Intake of Dried Cranberry 500 mg in Women with Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled Study. [2022]We sought to determine the efficacy of dried cranberry on reducing symptoms of overactive bladder in women.
Anthocran® Phytosome®: Prevention of Recurring Urinary Infections and Symptoms after Catheterization. [2023]In this preliminary pilot registry study, we investigated the effects of the oral supplementation of a standardized cranberry extract (Anthocran® Phytosome®, Indena) delivered by a lecithin-based system, for the prophylactic management of recurrent-urinary tract infections (R-UTIs). We included 64 otherwise healthy subjects who underwent a surgical procedure and required post-surgical urinary catheterization for high-risk UTIs or a previous history of R-UTIs. Patients were given supplementation with the standardized cranberry extract at the dose of either 120 mg/day (n = 12) or 240 mg/day (n = 12) or assigned to a control group consisting of standard management (SM; n = 18) or nitrofurantoin administration (n = 22) for 4 weeks. After 4 weeks, patients receiving the standardized cranberry supplementation reported to have a more effective reduction in UTI symptoms, as assessed on the visual analogue scale, compared with patients in the SM or nitrofurantoin groups. The occurrence of hematuria and urine bacterial contamination were decreased among patients treated with the supplement compared with controls (p < 0.05). The cranberry extract was also superior to the control management in terms of recurrence of signs/symptoms, with none of the patients in this group suffering from a R-UTI in the 3 months following the study end (p < 0.05). The supplementation showed an optimal safety profile, with no significant adverse events and no drop-outs in the supplement group. This registry shows that this cranberry extract is effective as a supplementary, preventive management in preventing post-operative, post-catheter UTIs; the product has a good tolerability profile.
Vaccinium macrocarpon (Cranberry)-Based Dietary Supplements: Variation in Mass Uniformity, Proanthocyanidin Dosage and Anthocyanin Profile Demonstrates Quality Control Standard Needed. [2021]Vaccinium macrocarpon (syn. American Cranberry) is employed in dietary supplements (DS) with the aim to improve urinary tract well-being. This property is linked to the antiadhesion-activity of proanthocyanidins (PACs) against uropathogenic-bacteria. However, the current European legislation has been criticized for being weak and ineffective. Indeed, recent scientific works report mislabeled, contaminated, and adulterated supplements containing dangerous or unknown compounds, or sold at toxic doses. In this work, we analysed 24 DS that claim to contain cranberry, and to have a specific dosage of PACs. Our tests included the control of the good manufacturing practice according to the European Pharmacopoeia, and the verification of the claimed dosage of PACs. Moreover, in order to confirm the real presence of cranberry in DS, chemical fingerprinting via HPLC-UV/Vis-MS/MS was employed. Our results showed that 17 DS did not comply with the uniformity test of dosage forms, and only five contained cranberry. Finally, 16 DS claimed an incorrect amount of PACs. These data suggest that several cranberry-based DS are present in the European market with insufficient quality controls. Considering that often DS are self-prescribed by consumer relying on their claim, the data obtained in this work should encourage more controls and stricter rules.
Novel concentrated cranberry liquid blend, UTI-STAT with Proantinox, might help prevent recurrent urinary tract infections in women. [2014]To determine the safety, tolerability, maximal tolerated dose, and efficacy of a concentrated cranberry liquid blend, UTI-STAT with Proantinox, in female patients with a history of recurrent urinary tract infections (rUTIs).
Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97. [2023]Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 'cranberry extract powder' as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The NF contains about 55-60% proanthocyanidins (PACs). The Panel considers that the information provided on the composition, the specifications, batch-to-batch variability and stability of the NF is sufficient and does not raise safety concerns. Cranberry extract powder is produced from cranberry juice concentrate through an ethanolic extraction using an adsorptive resin column to retain the phenolic components. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food. The NF is intended to be added to beverages and yogurts to provide 80 mg PACs per serving. The target population is the adult general population. The mean and 95th percentile estimates for the all-user intakes from all proposed food-uses are 68 and 192 mg/day, respectively, for female adults, and 74 mg/day and 219 mg/day, respectively, for male adults. Taking into account the composition of the novel food and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. While no animal toxicological studies have been conducted on the NF, a number of human clinical studies have been conducted with cranberry products. Considering the composition, manufacturing process, intake, history of consumption of the source and human data, the Panel considers that the data provided do not give reasons for safety concerns. The Panel concludes that the cranberry extract powder is safe as a food ingredient at the proposed uses and use levels.
Effect of american cranberry (Cysticlean) on Escherichia coli adherence to bladder epithelial cells. In vitro and in vivo study. [2017]The American cranberry proanthocyanidins (PACs) are the main responsible for its efficacy in urinary tract infections. Their mechanism of action is related to inhibition of Escherichia coli to urothelial cells. Cysticlean contains an extract of American cranberry which provides 118 mg of PACs per dose. The activity of Cysticlean tablets on Escherichia Coli adherence to bladder epithelial cells has been studied in vitro. Moreover, the activity of Cistyclean both in powder for oral suspension and tablets has been compared ex-vivo.
Supplementation with high titer cranberry extract (Anthocran®) for the prevention of recurrent urinary tract infections in elderly men suffering from moderate prostatic hyperplasia: a pilot study. [2018]Recently, cranberry extracts have been tested as a nutritional supplementation in the prevention of lower urinary tract symptoms (LUTS) as well as recurrent urinary tract infections (UTIs) in subjects at risk, with mixed results. However, evidence of efficacy should be considered only for well-characterized and standardized products in a more selected study population. Moreover, the efficacy of these interventions in elderly must be further investigated. The aim of this pilot, registry study was to evaluate the prophylactic effects of an oral supplementation containing a highly concentrated and standardized cranberry extract reproducing the natural total profile of cranberry fruits, in elderly men with benign prostatic hyperplasia (BPH), suffering from recurrent UTIs, over a 2-months follow-up.
Cranberry supplementation in the prevention of non-severe lower urinary tract infections: a pilot study. [2018]Cranberry extracts have been tested as a nutritional supplementation in the prevention of recurrent lower-urinary tract infections (R-UTIs), with mixed results. This pilot, registry study evaluates the prophylactic effects of oral supplementation with a new well-standardized cranberry extract in patients with R-UTI, over a 2-month follow-up.