Urinary Microbiome Changes Following Administration of 500 Mg of NDS-446 in Women with Dry OAB At 12 Weeks

Launched by LOYOLA UNIVERSITY · Sep 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a specific natural supplement, dried cranberry powder extract (called NDS-446), affects the bacteria in the bladders of women who have overactive bladder (OAB) symptoms. Women with OAB often feel a strong urge to urinate, and they might go to the bathroom more than eight times a day, but they do not experience accidental leakage. The goal is to see if taking 500 mg of this cranberry extract can change the bladder's bacteria in a positive way over a 12-week period.

To participate in this study, women must be at least 18 years old and have had OAB symptoms for more than six months. They should be able to walk and must keep a diary for three days showing their bathroom habits, which should include having more than three strong urges to go without leaking. However, women who have had recent urinary infections, certain bladder conditions, or have been treated for OAB in the last two months are not eligible. Participants will take the supplement and will be monitored throughout the study, helping researchers learn more about potential new treatments for OAB.

Gender

FEMALE

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