RECRUITING

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

Conditions

Lower Urinary Tract Symptoms Overactive Bladder Syndrome MitoQ gerotherapeutics urgency urinary urgency metabolic syndrome aging LUTS OAB geroscience

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, 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.)

Official Title

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

Quick Facts

Study Start:2024-04-03

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06351683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Having the metabolic syndrome per the new International Diabetes Federation's 2006 consensus worldwide definition for metabolic syndrome. * Having urgency with or without other urinary symptoms for at least 3 months. * Women aged 50 years and 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	* Frailty, defined as meeting 3 of 5 frailty indicators of the Fried Frailty Phenotype * History of severe renal impairment and/or estimated glomerular filtration rate, eGFR ≤ 70 mL/min/1.73m2 * Excessive alcohol use (more than 14 alcoholic drinks/week) * Clinical/laboratory evidence of hepatic disease (via medical history and/or Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 3 times upper limit of normal at screening) * Diabetes mellitus (glycated hemoglobin or hemoglobin A1c, HbA1c \>6.5%) * 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, Amyotrophic lateral sclerosis (ALS), multiple sclerosis (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 cancer. * 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 non-steroidal anti-inflammatory drugs (NSAIDs) will not be an exclusion criterion. * Significant co-morbid disease (severe chronic obstructive pulmonary disease, active rheumatologic diseases, chronic infection (human immunodeficiency virus (HIV), tuberculosis), severe congestive heart failure (NYHA class 4), myocarditis, etc) * Myocardial infarction, stroke or hospitalization for heart failure in the last 12 months * Corrected QT interval, QTc \>460 ms (milliseconds) at screening on electrocardiogram (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. * Subjects must not be on or have taken anti-muscarinics or β3- adrenoreceptor agonists for 3 weeks prior to visit 1.

Inclusion Criteria

Exclusion Criteria

* Having the metabolic syndrome per the new International Diabetes Federation's 2006 consensus worldwide definition for metabolic syndrome.
* Having urgency with or without other urinary symptoms for at least 3 months.
* Women aged 50 years and 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

* Frailty, defined as meeting 3 of 5 frailty indicators of the Fried Frailty Phenotype
* History of severe renal impairment and/or estimated glomerular filtration rate, eGFR ≤ 70 mL/min/1.73m2
* Excessive alcohol use (more than 14 alcoholic drinks/week)
* Clinical/laboratory evidence of hepatic disease (via medical history and/or Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 3 times upper limit of normal at screening)
* Diabetes mellitus (glycated hemoglobin or hemoglobin A1c, HbA1c \>6.5%)
* 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, Amyotrophic lateral sclerosis (ALS), multiple sclerosis (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 cancer.
* 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 non-steroidal anti-inflammatory drugs (NSAIDs) will not be an exclusion criterion.
* Significant co-morbid disease (severe chronic obstructive pulmonary disease, active rheumatologic diseases, chronic infection (human immunodeficiency virus (HIV), tuberculosis), severe congestive heart failure (NYHA class 4), myocarditis, etc)
* Myocardial infarction, stroke or hospitalization for heart failure in the last 12 months
* Corrected QT interval, QTc \>460 ms (milliseconds) at screening on electrocardiogram (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.
* Subjects must not be on or have taken anti-muscarinics or β3- adrenoreceptor agonists for 3 weeks prior to visit 1.

Contacts and Locations

Study Contact

Lisa Kenyon-Pesce

CONTACT

(860) 679-2305

kenyon-pesce@uchc.edu

Principal Investigator

Iman M Al-Naggar, PhD

PRINCIPAL_INVESTIGATOR

UConn Health

Study Locations (Sites)

UConn Health

Farmington, Connecticut, 06030

United States

Collaborators and Investigators

Sponsor: Iman Al-Naggar, PhD

Iman M Al-Naggar, PhD, PRINCIPAL_INVESTIGATOR, UConn Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-04-03

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

MitoQ
gerotherapeutics
urgency
urinary urgency
metabolic syndrome
aging
LUTS
OAB
geroscience

Additional Relevant MeSH Terms

Lower Urinary Tract Symptoms
Overactive Bladder Syndrome