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Recruiting Phase 4 NCT05557279

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

Trial Parameters

Condition Overactive Bladder
Sponsor Loyola University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 40
Sex FEMALE
Min Age 18 Years
Max Age 99 Years
Start Date 2023-01-01
Completion 2025-12-01
Interventions
500 mg NDS-446

Brief 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.

Eligibility Criteria

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

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