protocolSection identificationModule nctId: NCT06351683, orgStudyIdInfo id: 24-066-2, secondaryIdInfos id: P30AG067988, type: NIH, link: https://reporter.nih.gov/quickSearch/P30AG067988, briefTitle: Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome, acronym: Mito-LUTS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Iman Al-Naggar, PhD, class: OTHER, collaborators name: National Institute on Aging (NIA), collaborators name: American Urological Association, collaborators name: Urology Care Foundation, collaborators name: Claude D. Pepper Older Americans Independence Center (OAIC), descriptionModule briefSummary: The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women aged 50-75 years old who have the metabolic syndrome. The main questions it aims to answer are:* Is the study design feasible and acceptable to participants?* Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo (a look-alike substance that contains no drug)?Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.), conditionsModule conditions: Lower Urinary Tract Symptoms, conditions: Overactive Bladder Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blinded. Pharmacy will randomize and dispense capsules., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: MitoQ (mitoquinol mesylate), interventions name: Placebo, outcomesModule primaryOutcomes measure: Overactive Bladder Symptom Score (OABSS), secondaryOutcomes measure: Three-day bladder voiding diary, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UConn Health, status: RECRUITING, city: Farmington, state: Connecticut, zip: 06030, country: United States, contacts name: Lisa Kenyon-Pesce, role: CONTACT, phone: 860-679-2305, email: kenyon-pesce@uchc.edu, contacts name: Peter C Albertsen, MD, role: SUB_INVESTIGATOR, contacts name: George A Kuchel, MD, role: SUB_INVESTIGATOR, contacts name: Jenna M Bartley, PhD, role: SUB_INVESTIGATOR, contacts name: Oh Sung Kwon, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.71982, lon: -72.83204, hasResults: False