Lower Urinary Tract SymptomsPhase 2Mito-LUTSNCT06351683
Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome
A Phase 2 study testing MitoQ (mitoquinol mesylate) in people with Lower Urinary Tract Symptoms and Overactive Bladder Syndrome, run by Iman Al-Naggar, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Overactive Bladder Syndrome
- What is being tested?
- MitoQ (mitoquinol mesylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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).
- Clean intermittent catheterization or indwelling catheter
- Current participation in another interventional study
- Pregnancy and nursing
- Subjects must not have used antibiotics for at least 3 weeks prior to visit 1, received a vaccination in the 2 weeks prior to visit 1 or used medicine that alters the immune response (eg high dose corticosteroids) in the 6 months prior to visit 1. Subjects must not have had an acute infection in the 3 weeks prior to visit 1 or had a major severe illness or been hospitalized in the 3 months prior to visit 1. If participants are within any of these windows when they are screened, they will be scheduled for a screening visit but will only be invited for Visit 1 after these specified windows have elapsed and/or infections have resolved.
- Subjects must not be on or have taken any of the following anti-muscarinics or β3- adrenoreceptor agonists for 3 weeks prior to visit 1: o Darifenacin (enablex), Oxybutynin (ditropan), Solifenacin (vesicare), Fesoterodine (Toviaz), Tolterodine (detrol), Trospium (sanctura), Imipramine (tofranil), Mirabegron (myrbetriq), Vibegron (gemtesa)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mito-LUTS: A Pilot Study of the Effect of MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome
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.)
Read the detailed description
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.
- Being tested
- MitoQ (mitoquinol mesylate), Placebo
- Keywords
- MitoQ, gerotherapeutics, urgency, urinary urgency, metabolic syndrome, aging, LUTS, OAB, geroscience
- Medical subject headings
- Lower Urinary Tract Symptoms, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQ (mitoquinol mesylate)Drug
Also called MitoQ
MitoQ is an antioxidant molecule designed to target cell stress
PlaceboOther
Control capsules that contain all inactive ingredients found in the study drug capsules (i.e., placebo capsules do not contain mitoquinol mesylate)
| Study group | Role | What they receive |
|---|---|---|
| MitoQ group | Experimental | 2x20mg MitoQ (mitoquinol mesylate) capsules taken orally daily before breakfast for 4 months Receives: Drug: MitoQ (mitoquinol mesylate) |
| Placebo Control group | Placebo comparator | 2 placebo capsules taken orally daily before breakfast for 4 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Symptom Score (OABSS)
The OBSS is a validated bladder symptom questionnaire routinely used in assessing lower urinary tract symptoms and overactive bladder syndrome.
The OABSS questionnaire consists of 4 questions and has a minimum score of 0 and a maximum score of 15.
Scores on the OABSS of ≤5 are defined as mild, those of 6-11 as moderate, and those of ≥12 as severe LUTS.
Measured: From enrollment to the end of treatment at Week 16
Secondary outcomes (1)
Three-day bladder voiding diary
Participants will record times and amounts of liquids ingested and urine produced for 3 days. They will also record their urge at each voiding instance and incontinence episodes. Voiding diary measures, including number of voids during the day, number of voids during the night, number of urgency episodes and number of incontinence episodes will all be compared.
Measured: From Baseline Visit (Week 0) to end of treatment at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start3 Apr 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Why it stopped: Recruitment not proceeding as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iman Al-Naggar, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), American Urological Association, Urology Care Foundation, Claude D. Pepper Older Americans Independence Center (OAIC)
- Responsible party
- Sponsor-investigator, Iman Al-Naggar, PhD, UConn Health
- Investigators
- Iman M Al-Naggar, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351683
- Sponsor's protocol ID
- 24-066-2
- Other IDs
- P30AG067988
- Acronym
- Mito-LUTS
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mito-LUTS: A Pilot Study of the Effect of MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06351683
- Acronym / sponsor ID
- Mito-LUTS / 24-066-2
- Keywords
- MitoQ, gerotherapeutics, urgency, urinary urgency, metabolic syndrome, aging, LUTS, OAB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment not proceeding as planned.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Iman Al-Naggar, PhDUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), American Urological Association, Urology Care Foundation, Claude D. Pepper Older Americans Independence Center (OAIC)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitoQ group | Experimental | Drug: MitoQ (mitoquinol mesylate)2x20mg MitoQ (mitoquinol mesylate) capsules taken orally daily before breakfast for 4 months |
| Placebo Control group | Placebo comparator | Other: Placebo2 placebo capsules taken orally daily before breakfast for 4 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQ (mitoquinol mesylate)Also: MitoQMitoQ is an antioxidant molecule designed to target cell stress | Drug | MitoQ group |
| PlaceboControl capsules that contain all inactive ingredients found in the study drug capsules (i.e., placebo capsules do not contain mitoquinol mesylate) | Other | Placebo Control group |
Primary outcome
Overactive Bladder Symptom Score (OABSS)
Time frame: From enrollment to the end of treatment at Week 16
The OBSS is a validated bladder symptom questionnaire routinely used in assessing lower urinary tract symptoms and overactive bladder syndrome. The OABSS questionnaire consists of 4 questions and has a minimum score of 0 and a maximum score of 15. Scores on the OABSS of ≤5 are defined as mild, those of 6-11 as moderate, and those of ≥12 as severe LUTS.
1 secondary outcome
Three-day bladder voiding diary
Time frame: From Baseline Visit (Week 0) to end of treatment at Week 16
Results and safety
The study was stopped early (reason given: Recruitment not proceeding as planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iman M Al-Naggar, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MitoQ (mitoquinol mesylate) in people with Lower Urinary Tract Symptoms and Overactive Bladder Syndrome, run by Iman Al-Naggar, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment not proceeding as planned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive Bladder Symptom Score (OABSS) (time frame: From enrollment to the end of treatment at Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.