CompletedPhase 2

Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks

United States53 participantsStarted 2023-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 99 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare the UG microbiota (vagina, peri-urethral, catheterized and voided urine) of female participants with urgency-frequency syndrome after 12 weeks of daily use of 500 mg of NDS-446 to the UG microbiota at baseline.

Timeframe: 12 week visit

Trial details

NCT IDNCT05557279

SponsorLoyola University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-11

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