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Cranberry Powder for Overactive Bladder

EM
Overseen byElizabeth Mueller, MD
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

Is the treatment 500 mg NDS-446 cranberry powder promising for overactive bladder?

Yes, the treatment 500 mg NDS-446 cranberry powder is promising for overactive bladder. A study showed that daily intake of dried cranberry helped reduce symptoms in women with this condition.67111213

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.
See 9 more

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 Canada for the following indications:

🇨🇦
Approved in Canada as Cranberry Powder for:
  • Prevention of Urinary Tract Infections (UTIs)
  • Urinary Urgency and Frequency

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials
161
Recruited
31,400+
Jerome D. Jabbour profile image

Jerome D. Jabbour

Loyola University

Chief Executive Officer since 2018

B.A. in Psychology from Loyola University in Baltimore, Maryland

Dr. Chris Cabell profile image

Dr. Chris Cabell

Loyola University

Chief Medical Officer since 2024

Medical Degree and Masters in Health Sciences from Duke University

Findings from Research

Imidafenacin 0.1 mg taken twice daily significantly reduced the number of daily micturitions and urge incontinence episodes in Taiwanese patients with overactive bladder after 12 weeks of treatment, compared to placebo.
The study, involving 118 patients, showed that while adverse events occurred in both groups, the safety profile of imidafenacin was acceptable, with common side effects including dry mouth and constipation.
A double-blind, randomized, placebo-controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan.Chuang, YC., Lin, CC., Chow, PM., et al.[2021]
Capsaicin treatment significantly reduced voiding frequency and increased bladder capacity in patients with overactive and hypersensitive bladders, demonstrating its effectiveness as a therapeutic option.
The treatment was well-tolerated and cost-effective, as it can be produced locally in Thailand, making it an accessible alternative for managing bladder conditions.
The efficacy of Thai capsaicin in management of overactive bladder and hypersensitive bladder.Soontrapa, S., Ruksakul, W., Nonthasood, B., et al.[2013]
In a 12-week study involving 241 patients, solifenacin succinate significantly reduced overactive bladder symptoms, as measured by the overactive bladder symptom score (OABSS), with a mean reduction of 3.76 points (61.21% improvement).
The treatment was well-tolerated, with an overall adverse event rate of 19.91%, primarily gastrointestinal, indicating that solifenacin is an effective option for managing OAB symptoms while maintaining patient safety.
Overactive bladder symptom score to evaluate efficacy of solifenacin for the treatment of overactive bladder symptoms.Liu, M., Wang, J., Yang, Y., et al.[2015]

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]
The efficacy of Thai capsaicin in management of overactive bladder and hypersensitive bladder. [2013]
Overactive bladder symptom score to evaluate efficacy of solifenacin for the treatment of overactive bladder symptoms. [2015]
Solifenacin significantly improves all symptoms of overactive bladder syndrome. [2022]
[Efficacy and safety of imidafenacin in female patients with urge and mixed urinary incontinence]. [2012]
Efficacy of Daily Intake of Dried Cranberry 500 mg in Women with Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled Study. [2022]
Anthocran® Phytosome®: Prevention of Recurring Urinary Infections and Symptoms after Catheterization. [2023]
Vaccinium macrocarpon (Cranberry)-Based Dietary Supplements: Variation in Mass Uniformity, Proanthocyanidin Dosage and Anthocyanin Profile Demonstrates Quality Control Standard Needed. [2021]
Novel concentrated cranberry liquid blend, UTI-STAT with Proantinox, might help prevent recurrent urinary tract infections in women. [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97. [2023]
Effect of american cranberry (Cysticlean) on Escherichia coli adherence to bladder epithelial cells. In vitro and in vivo study. [2017]
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]
Cranberry supplementation in the prevention of non-severe lower urinary tract infections: a pilot study. [2018]