RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-01

Study Completion:2025-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05557279

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Mary Tulke, RN

CONTACT

708-216-2186

mtulke@luc.edu

Elizabeth Mueller, MD

CONTACT

708-216-2170

emuelle@lumc.edu

Principal Investigator

Elizabeth Mueller, MD

PRINCIPAL_INVESTIGATOR

Loyola Medical Center

Study Locations (Sites)

Loyola Medical Center

Maywood, Illinois, 60153

United States

Collaborators and Investigators

Sponsor: Loyola University

Elizabeth Mueller, MD, PRINCIPAL_INVESTIGATOR, Loyola Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01

Study Completion Date2025-02-01

Study Record Updates

Study Start Date2023-01-01

Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

Overactive Bladder