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

NCT05557279 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 215838
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Compare the UG microbiota (vagina, peri-urethral, catheterized and voided urine) of female participants with urgency-frequency syndrome after 12 weeks of daily use of 500 mg of NDS-446 to the UG microbiota at baseline.

  Vaginal and peri-urethral swabs, as well as voided and catheterized urine specimens, will be obtained.

  12 week visit

Secondary Outcomes (1)

• Compare the baseline and 12 week PPBC score in pre-menopausal and post-menopausal who take 500 mg of NDS-446 daily.

  12 week visit

Study Arms (1)

Intervention Group

OTHER

All participants will receive 500 mg NDS-446 daily for 12 weeks

Drug: 500 mg NDS-446

Interventions

500 mg NDS-446 DRUG

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Mueller, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Tulke, RN

CONTACT

708-216-2186; mtulke@luc.edu

Elizabeth Mueller, MD

CONTACT

708-216-2170; emuelle@lumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment and meeting inclusion/exclusion criteria 20 premenopausal women, 20 postmenopausal women not on estrogen supplementation

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 28, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)