Effects of cranberry extract on urinary bacteria in women with overactive bladder
Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks - a Single-center Study
PHASE4 · Loyola University · NCT05557279
This study is testing if taking cranberry extract can help women with overactive bladder symptoms by looking at how it affects the bacteria in their urine over 12 weeks.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Loyola University (other) |
| Locations | 1 site (Maywood, Illinois) |
| Trial ID | NCT05557279 on ClinicalTrials.gov |
What this trial studies
This study investigates how a 500 mg dose of dried cranberry powder extract (NDS-446) influences the urinary microbiome in women experiencing overactive bladder (OAB) symptoms without urinary leakage. By utilizing advanced techniques like Expanded Quantitative Urine Culture (EQUC) and 16S ribosomal RNA sequencing, the research aims to understand changes in the bladder's bacterial composition over a 12-week period. The study seeks to explore the potential of cranberry extract as a treatment option for OAB, given its known benefits in preventing urinary tract infections and its role in maintaining a healthy urogenital microbiome.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with overactive bladder symptoms lasting more than six months.
Not a fit: Patients with a history of urinary incontinence or those who have had recent urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for women suffering from overactive bladder symptoms.
How similar studies have performed: Other studies have shown promising results in targeting the urinary microbiome for urogenital conditions, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Maywood, Illinois
- Loyola Medical Center — Maywood, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Elizabeth Mueller, MD — Loyola Medical Center
- Study coordinator: Mary Tulke, RN
- Email: mtulke@luc.edu
- Phone: 708-216-2186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overactive Bladder