MitoQ for Lower Urinary Tract Symptoms
(Mito-LUTS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Iman Al-Naggar, PhD
Must not be taking: NSAIDs, Blood thinners, Immunosuppressants, others
Disqualifiers: Diabetes, Cancer, Neurological disorders, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.)
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as anti-muscarinics and β3-adrenoreceptor agonists, for at least 3 weeks before starting. You also cannot be on blood thinners like warfarin or have used antibiotics recently. It's best to discuss your current medications with the trial team to see if any need to be paused.
How is the drug MitoQ different from other treatments for lower urinary tract symptoms?
MitoQ is unique because it targets mitochondria, the energy-producing parts of cells, to reduce oxidative stress, which is different from other treatments that often focus on relaxing bladder muscles or altering hormone levels. This novel approach may offer benefits without the long-term side effects associated with some existing drugs for lower urinary tract symptoms.
12345Eligibility Criteria
This trial is for women aged 50-75 with metabolic syndrome who experience bladder issues like urgency and frequency. Participants must be willing to take capsules, answer health questions, undergo tests, provide samples, keep a bladder diary, and attend visits and calls over 4 months.Participant Groups
Researchers are testing MitoQ supplements against a placebo to see if they improve bladder symptoms in older women with metabolic syndrome. The study involves taking two capsules daily for four months and monitoring the effects on urinary tract symptoms.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MitoQ groupExperimental Treatment1 Intervention
2x20mg MitoQ (mitoquinol mesylate) capsules taken orally daily before breakfast for 4 months
Group II: Placebo Control groupPlacebo Group1 Intervention
2 placebo capsules taken orally daily before breakfast for 4 months
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UConn HealthFarmington, CT
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Who is running the clinical trial?
Iman Al-Naggar, PhDLead Sponsor
National Institute on Aging (NIA)Collaborator
American Urological AssociationCollaborator
Urology Care FoundationCollaborator
Claude D. Pepper Older Americans Independence Center (OAIC)Collaborator
References
Quisqualis indica extract for men with lower urinary tract symptoms: A randomized, double-blind, placebo-controlled trial. [2023]Label="PURPOSE">To evaluate the efficacy and safety of Quisqualis indica in men with moderate lower urinary tract symptoms (LUTS).
Pharmacology of the lower urinary tract: update on LUTS treatment. [2020]The number of compounds used in the pharmacological treatment of lower urinary tract symptoms (LUTS) of patients who do not respond to conservative measures has been relatively stable during the last decade, with the exception of the introduction of the new class of β3 adrenoceptor agonists. However, different combinations have been investigated, and the long-term use of these compounds has raised new concerns about adherence and safety. This review summarizes the current state of pharmacology for LUTS, and presents a thorough discussion of the possible challenges concerning their future use. In this narrative review, we analyze the most recent articles related to LUTS pharmacotherapy, after an initial review of mechanisms of bladder function relevant in present clinical practice. The main problems with pharmacotherapy in LUTS are associated with its moderate efficacy, low persistence on treatment, and the incidence of short- and long-term adverse events (AE) associated with some compounds. The long-term AE, such as cognitive impairment in the elderly vulnerable patients associated with antimuscarinic drugs or persistent erectile dysfunction in sexually active men after treatment with 5-α-reductase inhibitors (5-ARI), are some of the problems addressed in this review. Combination therapy taking advantage of the synergistic mechanisms of action between some classes of compounds may overcome AE associated with dose escalation. LUTS pharmacotherapy offers moderate results to most patients but not a full cure. The use of combination drugs to achieve better clinical results, reduce AE and improve both efficacy and adherence, will be used more frequently in the future. The recently raised concern on potential long-term irreversible AE associated with some of these drugs, like antimuscarinics and 5-ARI, are critically important and require further investigation.
Transobturator midurethral sling: What should patients expect after surgery? [2022]Midurethral sling (MUS) surgeries are minimally invasive procedures; however, they are not free of postoperative complications. The aim of the study was to assess the occurrence of lower urinary tract symptoms (LUTS) (urgency, nocturia, frequency, splitting/spraying, hesitancy, terminal dribbling, and subjective feeling of postvoid residual) in patients suffering from stress (SUI) or mixed (MUI) urinary incontinence with a predominant SUI component before and after transobturator MUS placement.
Early vs late midline sling lysis results in greater improvement in lower urinary tract symptoms. [2009]Lower urinary tract symptoms (LUTS) occur in 5-20% of women after antiincontinence procedures. Symptoms include complete urinary retention or storage, voiding, and postmicturition symptoms. The goal of this study was to determine the effect of time from sling placement to midline sling lysis on overall improvement in LUTS.
Development and validation of the International Consultation on Incontinence Modular Questionnaire for Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) and the ICIQ-MLUTS Long Form in Chinese population. [2020]The aim of this study was to develop and validate Chinese versions of the International Consultation on Incontinence Modular Questionnaire for Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) and ICIQ-MLUTS Long Form (LF), and to discuss their potential functions.