Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome (NCT06351683) | Clinical Trial Compass
TerminatedPhase 2
Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome
Stopped: Recruitment not proceeding as planned.
United States20 participantsStarted 2024-04-03
Plain-language summary
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.)
Who can participate
Age range
50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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
Exclusion Criteria
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overactive Bladder Symptom Score (OABSS)
Timeframe: From enrollment to the end of treatment at Week 16