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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Lower Urinary Tract Symptoms, Overactive Bladder Syndrome

In brief

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 50 years and older 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 (optional), 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.)

Key facts

Study ID: NCT06351683
Run by: Iman Al-Naggar, PhD
People needed: 20
Starts: 2024-04-03
Expected to finish: 2026-04-01
Last updated by the study team: 2026-05-01

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

The new IDF's 2006 consensus worldwide definition for MetS will be followed for inclusion. MetS will be defined as having central obesity with ethnicity-specific values, plus two or more of the following criteria: Hypertension, dyslipidemia, or hyperglycemia. Hypertension is defined by the use of antihypertensive medication and/or blood pressure of ≥130/85 mmHg. Dyslipidemia is defined as blood triglycerides >150mg/dL or high-density lipoprotein (HDL) < 50mg/dL, or specific treatment for either lipid abnormality. Hyperglycemia is defined as a fasting glucose ≥100mg/dL. Inclusion criteria for LUTS are having urgency with or without other urinary symptoms for at least 3 months, with a score of 1 or 2 on the Urgency Perception Scale questionnaire 60 , and a total score of at least 6 on the OABSS questionnaire (with at least a score of 2 on the third OABSS question "How often do you have a sudden desire to urinate, which is difficult to defer?").
Women 50years or older with metabolic syndrome and LUTS as defined above.
Speak, read and understand English
Willingness to provide consent and participate in all aspects of the trial including randomization to the intervention group

You may not qualify if…

The exclusion criteria for Mito-LUTS include conditions that will interfere with our research questions, including advanced co-morbidities and immunological disorders. They are as follows:
Frailty, defined as meeting 3 of 5 frailty indicators of the Fried Frailty Phenotype
History of severe renal impairment and/or eGFR ≤ 60 mL/min/1.73m2 at the study physician's discretion
Excessive alcohol use (more than 14 alcoholic drinks/week)
Clinical/laboratory evidence of hepatic disease (via medical history and/or AST and/or ALT ≥ 3 times upper limit of normal at screening)
Poorly Controlled Diabetes
Unwilling or unable (due to significant cognitive impairment) to provide informed consent.
Terminal illness with life expectancy less than 12 months
Advanced neurological disorder (Alzheimer's, Parkinson's, ALS, MS, dementia, seizures)
A score of 30 or less on the modified Telephone Screening of Cognitive Status administered during the in-person screening visit.
Cancer or history of gynecological cancer or history of cancer requiring chemotherapy or radiation at the study physician's discretion.
A history of gastric ulcers.
Abnormal findings on endoscopy.
Recent (within the last 2 weeks) or current chronic use of NSAIDs or other drugs or agents with the potential for gastric mucosal toxicity (except for daily use of baby aspirin or famotidine for which participants will not be excluded). Sporadic use of NSAIDs will not be an exclusion criterion.
Significant co-morbid disease (severe chronic obstructive pulmonary disease, active rheumatologic diseases, chronic infection (HIV, tuberculosis), severe congestive heart failure (NYHA class 4), myocarditis, etc)
Myocardial infarction, stroke or hospitalization for heart failure in the last 12 months
QTc >460 ms at screening on ECG
Prior diagnosis of ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
Severe active psychiatric disorder (e.g. bipolar, schizophrenia)
Unable to complete physical performance testing due to medical conditions (at discretion of the PI)
Unintentional weight loss >15 lbs in past 12 months
Immunosuppressive disorders or taking immunosuppressive medications (including oral prednisone > 10mg/day)
Sub-cerebellar lesions
Subjects must not be on warfarin or other blood thinning medications or have a known bleeding disorder.
Conditions that might interfere with clinical diagnosis (such as pelvic organ prolapse ≥ stage 2, pelvic radiotherapy, any concurrent condition that could cause incontinence, hematuria, vaginitis, neurogenic lower urinary tract dysfunction); chronic pelvic pain syndrome, interstitial cystitis/bladder pain syndrome, pelvic malignancy, active urinary tract infection (UTI), recent urologic procedure (<6 months).

Where it is running

UConn Health — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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