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

Completed · Phase 2

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT05557279

Run by

Loyola University

People needed

53

Starts

2023-01-01

Expected to finish

2025-08-11

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loyola Medical Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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