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Cranberry Powder for Overactive Bladder

Phase 4
Recruiting
Led By Elizabeth Mueller, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older, female, and ambulatory
Voiding frequency of more than 8 times in 24 hours and more than 3 episodes of urgency (grade 3 or 4) without incontinence during 3-day diary at baseline
Must not have
Underwent LUT surgery in the last 6 months
More than 3 UTIs in the last 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week visit
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial looks at the effect of cranberry powder on bladder bacteria in women with urinary urgency and frequency.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects aren't listed here, typical reactions might include digestive discomfort such as bloating or stomach upset due to the cranberry extract. Allergic reactions could occur in those sensitive to cranberries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman, 18 or older, and can walk.
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I use the bathroom more than 8 times a day and feel a strong urge to urinate more than 3 times without leaking.
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I have had overactive bladder symptoms for over 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had surgery on my lower urinary tract in the last 6 months.
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I have had more than 3 UTIs in the past year.
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I have experienced urinary incontinence more than 3 times last month.
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I have been treated for overactive bladder in the last 60 days or am on medication affecting bladder control.
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I take more than 81 mg of aspirin daily.
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I have been diagnosed with painful bladder syndrome or interstitial cystitis.
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I am currently taking medication to prevent blood clots.
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I am experiencing visible blood in my urine.
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I cannot swallow pills.
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I am currently on Warfarin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vagina
Secondary study objectives
Compare the baseline and 12 week PPBC score in pre-menopausal and post-menopausal who take 500 mg of NDS-446 daily.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
All participants will receive 500 mg NDS-446 daily for 12 weeks

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,379 Total Patients Enrolled
Elizabeth Mueller, MDPrincipal InvestigatorLoyola Medical Center
6 Previous Clinical Trials
533 Total Patients Enrolled

Media Library

500 mg NDS-446 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05557279 — Phase 4
Overactive Bladder Research Study Groups: Intervention Group
Overactive Bladder Clinical Trial 2023: 500 mg NDS-446 Highlights & Side Effects. Trial Name: NCT05557279 — Phase 4
500 mg NDS-446 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557279 — Phase 4
~0 spots leftby Dec 2024
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