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

NCT06351683 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

DRUG

MitoQ (mitoquinol mesylate)

MitoQ is an antioxidant molecule designed to target cell stress

OTHER

Placebo

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • American Urological Association

    collaborator OTHER

  • Urology Care Foundation

    collaborator UNKNOWN

  • Claude D. Pepper Older Americans Independence Center (OAIC)

    collaborator UNKNOWN

  • Iman Al-Naggar, PhD

    lead OTHER

Principal Investigators

  • Iman M Al-Naggar, PhD · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2026-04-01
Completion
2026-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06351683 on ClinicalTrials.gov