Overview

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

Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Loyola University
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