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

NCT06351683 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: 24-066-2P30AG067988
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.)

Conditions

Lower Urinary Tract Symptoms; Overactive Bladder Syndrome

Keywords

MitoQ; gerotherapeutics; urgency; urinary urgency; metabolic syndrome; aging; LUTS; OAB; geroscience

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at Week 16

Secondary Outcomes (1)

• Three-day bladder voiding diary

  From Baseline Visit (Week 0) to end of treatment at Week 16

Study Arms (2)

MitoQ group

EXPERIMENTAL

2x20mg MitoQ (mitoquinol mesylate) capsules taken orally daily before breakfast for 4 months

Drug: MitoQ (mitoquinol mesylate)

Placebo Control group

PLACEBO COMPARATOR

2 placebo capsules taken orally daily before breakfast for 4 months

Other: Placebo

Interventions

MitoQ (mitoquinol mesylate) DRUG

MitoQ is an antioxidant molecule designed to target cell stress

Also known as: MitoQ

MitoQ group

Placebo OTHER

Control capsules that contain all inactive ingredients found in the study drug capsules (i.e., placebo capsules do not contain mitoquinol mesylate)

Placebo Control group

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Sex assigned at birth is Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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.
• 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

Sponsors & Collaborators

• Iman Al-Naggar, PhD: lead
• National Institute on Aging (NIA): collaborator
• Claude D. Pepper Older Americans Independence Center (OAIC): collaborator
• American Urological Association: collaborator
• Urology Care Foundation: collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Metabolic Syndrome

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Iman M Al-Naggar, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy will randomize and dispense study drug and placebo. All others are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 8, 2024
• Study Start: April 3, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available 3 months and ending 5 years following article publication.
• Access Criteria: Anyone wishing to access the data may do so after signing a data access/data transfer agreement. Requests should be made by contacting Dr. Iman Al-Naggar at alnaggar@uchc.edu.

Locations

US (1)