NCT05557279
Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks
- Mary Tulke, RN - Role: CONTACT - Phone: 708-216-2186 - Email: mtulke@luc.edu
- Elizabeth Mueller, MD - Role: CONTACT - Phone: 708-216-2170 - Email: emuelle@lumc.edu
PHASE4
RECRUITING
NCT05557279
INTERVENTIONAL
Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks - a Single-center Study
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.
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
Overactive Bladder
- TREATMENT
-
- Type: DRUG
- Name: 500 mg NDS-446
- Description: All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment
- Arm Group Labels: Intervention Group
- Loyola University