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Antioxidant

MitoQ group for Overactive Bladder (Mito-LUTS Trial)

Phase 2

Recruiting

Led By Iman M Al-Naggar, PhD

Research Sponsored by Iman Al-Naggar, PhD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 4, week 8, week 12, week 16

Awards & highlights

Mito-LUTS Trial Summary

This trial aims to see if a supplement called MitoQ can help improve bladder symptoms in women aged 50-75 with metabolic syndrome. Participants will take the supplement daily for 4 months and undergo

Who is the study for?

This trial is for women aged 50-75 with metabolic syndrome who experience bladder issues like urgency and frequency. Participants must be willing to take capsules, answer health questions, undergo tests, provide samples, keep a bladder diary, and attend visits and calls over 4 months.Check my eligibility

What is being tested?

Researchers are testing MitoQ supplements against a placebo to see if they improve bladder symptoms in older women with metabolic syndrome. The study involves taking two capsules daily for four months and monitoring the effects on urinary tract symptoms.See study design

What are the potential side effects?

The description does not specify side effects of MitoQ; however, as with any supplement or medication, there could be potential risks which will be monitored throughout the study.

Mito-LUTS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 4, week 8, week 12, week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week 4, week 8, week 12, week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 4, week 8, week 12, week 16 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overactive Bladder Symptom Score (OABSS)

Secondary outcome measures

Three-day bladder voiding diary

Mito-LUTS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MitoQ groupExperimental Treatment1 Intervention

2x20mg MitoQ (mitoquinol mesylate) capsules taken orally daily before breakfast for 4 months

Group II: Placebo Control groupPlacebo Group1 Intervention

2 placebo capsules taken orally daily before breakfast for 4 months

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,835 Total Patients Enrolled

Iman Al-Naggar, PhDLead Sponsor

American Urological AssociationOTHER

4 Previous Clinical Trials

585 Total Patients Enrolled

Frequently Asked Questions

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

Are participants currently being sought for enrollment in this research study?

"Indeed, the details on clinicaltrials.gov affirm that this medical study is presently seeking candidates. This trial was initially made available on April 3rd, 2024 and was last revised on April 1st, 2024. The research project aims to enroll a total of 50 participants from one designated site."

Answered by AI

What is the current number of individuals actively participating in this research endeavor?

"Indeed, data available on clinicaltrials.gov affirms that this research investigation is actively seeking suitable participants. Initially shared on the 3rd of April in 2024 and most recently revised on the 1st of April in the same year, this study aims to enroll a total of 50 patients at one designated site."

Answered by AI

What is the overall safety profile of the MitoQ treatment regimen for individuals undergoing therapy?

"The safety rating for the MitoQ group has been determined as a 2 on a scale of 1 to 3 by our team at Power. This assessment aligns with it being a Phase 2 trial, indicating existing data on safety but lacking evidence on efficacy."

Answered by AI

Are participants aged 60 and above eligible for enrollment in this research?

"Individuals aged between 50 and 75 years are eligible to participate in this research. It is worth noting that there are considerably fewer studies available for those under 18, with a total of 399 trials, compared to the extensive pool of 1225 trials catering to individuals above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome

Iman Al-Naggar, PhD 2024. "Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06351683.

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