MitoQ for Lower Urinary Tract Symptoms

(Mito-LUTS Trial)

Recruiting in Farmington (>99 mi)

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

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. ^{1 2 3 4 5}

Research Team

Iman M Al-Naggar, PhD

Principal Investigator

UConn Health

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Quisqualis indica extract for men with lower urinary tract symptoms: A randomized, double-blind, placebo-controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacology of the lower urinary tract: update on LUTS treatment. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Transobturator midurethral sling: What should patients expect after surgery? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Early vs late midline sling lysis results in greater improvement in lower urinary tract symptoms. [2009]

5. Australia 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. [2020]