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Cranberry Powder for Overactive Bladder

Phase 4

Recruiting

Led By Elizabeth Mueller, MD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older, female, and ambulatory

Voiding frequency of more than 8 times in 24 hours and more than 3 episodes of urgency (grade 3 or 4) without incontinence during 3-day diary at baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 week visit

Awards & highlights

Study Summary

This trial looks at the effect of cranberry powder on bladder bacteria in women with urinary urgency and frequency.

Who is the study for?

This trial is for women over 18 with an overactive bladder (OAB) who have had symptoms like urinary urgency and frequency for more than six months. They must not have incontinence but do need to urinate often, more than eight times a day, and feel sudden urges to go. Women can't join if they've had lower urinary tract surgery recently, take certain medications like high-dose aspirin or Warfarin, have allergies to aspirin, trouble swallowing pills, frequent UTIs, painful bladder conditions or are on other OAB treatments.Check my eligibility

What is being tested?

The study tests how a dried cranberry powder extract (500 mg NDS-446) affects the bladder's bacteria in women with dry OAB. It aims to see if this natural remedy changes the urinary microbiome after 12 weeks of use without causing leakage problems.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical reactions might include digestive discomfort such as bloating or stomach upset due to the cranberry extract. Allergic reactions could occur in those sensitive to cranberries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman, 18 or older, and can walk.

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I use the bathroom more than 8 times a day and feel a strong urge to urinate more than 3 times without leaking.

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I have had overactive bladder symptoms for over 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 week visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 week visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vagina

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,894 Total Patients Enrolled

Elizabeth Mueller, MDPrincipal InvestigatorLoyola Medical Center

6 Previous Clinical Trials

533 Total Patients Enrolled

Media Library

500 mg NDS-446 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05557279 — Phase 4

Overactive Bladder Research Study Groups: Intervention Group

Overactive Bladder Clinical Trial 2023: 500 mg NDS-446 Highlights & Side Effects. Trial Name: NCT05557279 — Phase 4

500 mg NDS-446 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557279 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for involvement in this research endeavor?

"Candidates for this trial must be 18 years of age or older, not exceeding 99 years old, and suffer from overactive bladder syndrome (OABs). 40 individuals are needed to complete the study."

Answered by AI

Are adults of legal age being admitted for this experiment?

"Enrolment in this medical study mandates that participants must be aged 18 - 99. There are 7 studies available for minors and 59 pertinent research initiatives for seniors 65+ years old."

Answered by AI

Have they started recruiting participants for this trial yet?

"According to clinicaltrials.gov, this research project is no longer open for recruitment having been posted on October 1st 2022 and last updated on September 30th 2022. Despite this, there remain 66 other active trials admitting participants at present."

Answered by AI