RecruitingPhase 4NCT05557279

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

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


Sponsor

Loyola University

Enrollment

40 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Inclusion Criteria3

  • 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 Criteria12

  • 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

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Interventions

DRUG500 mg NDS-446

All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment


Locations(1)

Loyola Medical Center

Maywood, Illinois, United States

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NCT05557279


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