Mito-LUTS: A Pilot Study of the Effect of MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome

Both aging and the metabolic syndrome are risk factors for lower urinary tract symptoms (LUTS, including urgency, frequency, nocturia (nighttime urination), and incontinence). This study aims to test whether an oral supplement that targets biological aging pathways can improve lower urinary tract symptoms (LUTS) in women aged 50 years and older with the metabolic syndrome (a cluster of conditions that occur together, increasing the risk of heart disease, stroke and type 2 diabetes). MitoQ, a strong mitochondrial-targeted antioxidant molecule, has been shown to target mitochondrial dysfunction, oxidative stress, inflammation, and endothelial dysfunction, all aging pathways that are also found to be dysregulated in conditions that cause LUTS such as the overactive bladder syndrome. Women aged 50 years and older who have the metabolic syndrome per the new International Diabetes Federation (IDF) definition and have had urinary urgency for at least 3 months will be invited to participate in the study. They will be screened by phone for major study inclusion/exclusion criteria and then invited for an in-person screening visit where blood will be drawn and measurements taken to confirm eligibility. Once eligible, participants will be randomly assigned to MitoQ or placebo (2MitoQ:1placebo) and asked to take 2 capsules daily (40mg MitoQ total) 30 minutes before breakfast for 4 months. Participants will come back for study visits at 8 and 16 weeks, and will receive two study data collection phone calls at 4 and 12 weeks, where they will answer questions about their bladder. There will be many other shorter phone calls throughout the study to check for adherence and adverse events. In addition to questionnaires assessing bladder function, participants will undergo tests of frailty, physical function, cognitive function and asked many questions about their health and medication. We will also draw blood for safety assessment and to measure aging molecules in the blood at each visit and see whether they change with treatment. Urine will also be collected at each study visit and participants will be asked to collect urine at home (first morning and 24-hour urine) and bring it to each of their study visits, which will be used for measuring aging molecules and testing how they change with the study drug. Participants will also fill out three-day voiding diaries to provide information about their voiding and LUTS.