MitoQ for Lower Urinary Tract Symptoms

(Mito-LUTS Trial)

Overseen By Lisa Kenyon-Pesce

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Iman Al-Naggar, PhD

Must not be taking: NSAIDs, Blood thinners, Immunosuppressants, others

Disqualifiers: Diabetes, Cancer, Neurological disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supplement called MitoQ to determine its effectiveness in alleviating bladder problems, such as frequent urges to urinate, in women over 50 with metabolic syndrome. Metabolic syndrome includes conditions like high blood pressure, high blood sugar, and excess body fat around the waist. Participants will take either MitoQ or a placebo (a pill with no active ingredient) daily for four months. The trial aims to assess whether MitoQ improves bladder symptoms and if the study setup is effective for participants. Women who have experienced urgency or other bladder issues for at least three months and meet specific health criteria are suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating MitoQ's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that MitoQ is likely to be safe for humans?

Research has shown that MitoQ, the treatment under study, has undergone testing in people before. In earlier trials, most participants tolerated it well, with few reports of serious side effects. This suggests that the supplement might be safe for most individuals. MitoQ has also demonstrated benefits in other health areas, such as easing symptoms of prostate enlargement, supporting its potential safety and effectiveness. However, like any treatment, some individuals might experience mild side effects, such as an upset stomach or headaches. It is important to consult a doctor if there are concerns about side effects or safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lower urinary tract symptoms, which often involve alpha-blockers or antimuscarinics to relax bladder muscles or reduce bladder contractions, MitoQ is unique because it targets oxidative stress at the cellular level. MitoQ is an antioxidant that specifically accumulates in the mitochondria, protecting them from damage and potentially improving cellular function. Researchers are excited about MitoQ because it offers a novel mechanism of action that could address the underlying cellular issues contributing to urinary symptoms, rather than just alleviating the symptoms themselves.

What evidence suggests that MitoQ might be an effective treatment for lower urinary tract symptoms?

Research has shown that MitoQ, a supplement targeting aging processes, might help with bladder issues like urgency and frequency. Studies have found that MitoQ acts as an antioxidant, reducing inflammation and improving cellular function. It has been particularly noted to alleviate symptoms related to prostate problems, suggesting potential benefits for the bladder. In this trial, participants in the MitoQ group will take two 20mg MitoQ capsules daily to assess its effects on bladder health in women with metabolic syndrome. Early results suggest it could offer a new way to manage these symptoms without some side effects of other treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Iman M Al-Naggar, PhD

Principal Investigator

UConn Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willingness to provide consent and participate in all aspects of the trial including randomization to the intervention group

Having the metabolic syndrome per the new International Diabetes Federation's 2006 consensus worldwide definition for metabolic syndrome

Speak, read and understand English

Exclusion Criteria

My liver isn't working properly, shown by tests or my medical history.

I have an advanced neurological disorder like Alzheimer's or Parkinson's.

I have had a heart rhythm problem called ventricular arrhythmia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person), phone screening

Treatment

Participants take 2 capsules of MitoQ or placebo daily for 4 months, with regular health assessments and data collection

16 weeks

4 visits (in-person), multiple phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MitoQ

Trial Overview 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.

How Is the Trial Designed?

Group I: MitoQ group Experimental Treatment 1 Intervention

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

Group II: Placebo Control group Placebo Group 1 Intervention

2 placebo capsules taken orally daily before breakfast for 4 months

Who Is Running the Clinical Trial?

Iman Al-Naggar, PhD

Lead Sponsor

Trials

1

Recruited

50+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

American Urological Association

Collaborator

Trials

5

Recruited

640+

Urology Care Foundation

Collaborator

Trials

1

Recruited

50+

Claude D. Pepper Older Americans Independence Center (OAIC)

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

A 12-week treatment with Quisqualis indica significantly improved lower urinary tract symptoms (LUTS) in men, as measured by the International Prostate Symptom Score (IPSS), with both low-dose and high-dose groups showing benefits compared to placebo.

The high-dose group also demonstrated improvements in sexual function and urinary flow rates, indicating that Quisqualis indica is not only effective for LUTS but also well tolerated with positive effects on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quisqualis indica extract for men with lower urinary tract symptoms: A randomized, double-blind, placebo-controlled trial. Shin, D., Zhu, GQ., Tian, WJ., et al.[2023]

In a study of 112 women undergoing midline sling lysis for lower urinary tract symptoms (LUTS), those who had the procedure within 1 year of their initial sling placement showed a significantly higher improvement rate in symptoms (91%) compared to those who had the lysis later (71%).

The overall rate of recurrent stress urinary incontinence after midline sling lysis was low at 8.9%, indicating that the procedure is relatively safe and effective for managing LUTS following previous antiincontinence surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early vs late midline sling lysis results in greater improvement in lower urinary tract symptoms. South, MM., Wu, JM., Webster, GD., et al.[2009]

The Chinese versions of the ICIQ-MLUTS and ICIQ-MLUTS Long Form were validated with 135 and 230 male patients, respectively, showing strong internal consistency and reliability, making them effective tools for assessing lower urinary tract symptoms.

Both questionnaires demonstrated good criterion validity and responsiveness, indicating they can accurately reflect changes in symptoms before and after treatment, which is crucial for clinical practice and research in China.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Huang, W., Wang, Q., Chen, J., et al.[2020]

Pharmacological treatments for lower urinary tract symptoms (LUTS) have shown moderate efficacy but often lead to low adherence due to adverse events, particularly in elderly patients, such as cognitive impairment from antimuscarinic drugs and persistent erectile dysfunction from 5-α-reductase inhibitors.

Combination therapies that utilize the synergistic effects of different drug classes may improve treatment outcomes and reduce adverse effects, suggesting a shift towards more frequent use of these strategies in LUTS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology of the lower urinary tract: update on LUTS treatment. Abreu-Mendes, P., Silva, J., Cruz, F.[2020]

In a study of 106 women undergoing midurethral sling surgery for urinary incontinence, a significant number experienced lower urinary tract symptoms (LUTS) shortly after the procedure, with urgency and splitting/spraying being the most common complaints.

Despite the initial high occurrence of LUTS post-surgery, most symptoms improved significantly within 6 months, with 91.5% of patients reporting no incontinence episodes by that time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transobturator midurethral sling: What should patients expect after surgery? Rechberger, T., Wrobel, A., Zietek, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06351683?term=mitoQ&viewType=Table&rank=5

Testing MitoQ on Lower Urinary Tract Symptoms in Older ... 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 ...

2. trialx.com trialx.com/clinical-trials/listings/287211/testing-mitoq-on-lower-urinary-tract-symptoms-in-older-women-with-metabolic-syndrome/

Testing MitoQ on Lower Urinary Tract Symptoms in Older ... 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 ...

3. withpower.com withpower.com/trial/mitoq-for-lower-urinary-tract-symptoms-c60ad

MitoQ for Lower Urinary Tract Symptoms (Mito-LUTS Trial) Pharmacological treatments for lower urinary tract symptoms (LUTS) have shown moderate efficacy but often lead to low adherence due to adverse events, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10368918/

Antioxidant mitoquinone suppresses benign prostatic ... MitoQ administration alleviated pathological prostate enlargement and exerted anti-proliferative and antioxidant effects by suppressing the AR and NLRP3 ...

5. mitoq.com mitoq.com/pages/research?srsltid=AfmBOoojEtbVrBXw4NlaRwF-LU-qHzEgqa6nRpDrGYnNgbPI2SJOIsUG

mitoquinol mesylate research studies & clinical trials Results found that acute, high-dose MitoQ supplementation did not result in high concentrations of kidney injury biomarkers compared to placebo samples.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667137922000091

Pharmacological significance of MitoQ in ameliorating ... MitoQ restored impaired mitophagosome-lysosome fusion and lysosomal function, as well as mitochondrial dynamics balance, resulting in the elimination of damaged ...