Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks - a Single-center Study
Loyola University
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.
Description
While this treatment algorithm is the recommended approach to OAB management, recent research has resulted in the development of a new paradigm that may influence how this condition is treated in the future. This research focuses on the urinary microbiome and for a decade it has been known that urine is not sterile. Expanded Quantitative Urine Culture (EQUC) techniques have allowed for more comprehensive and accurate 16S ribosomal RNA sequencing of the urinary microbiome. Changes in the abundance and diversity of the resident microbiota have been associated with a number of urogenital conditio…
Eligibility
- Age range
- 18–99 years
- Sex
- Female
- Healthy volunteers
- No
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 m…
Interventions
- Drug500 mg NDS-446
All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment
Location
- Loyola Medical CenterMaywood, Illinois