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Clinical Trials: Kidney, Bladder, Prostate and Urinary
IRB No. 23-212-2 (Dr. Mina Boutrous, PI): Effects of Socioeconomic Disparities on the Long-term Outcomes of Hemodialysis Access
Goal This project is designed to contribute institutional data to a multi-institutional registry to evaluate the impact of socioeconomic disparities on the long-term outcomes of hemodialysis access, including the choice of access modality that the patient recieve, the long term patency of hemodialysis access and their access to healthcare services overall. Specific Objectives To determine the most prevalent type of access that patients from disadvantageous socioeconomic background receive. Hypothesis: Patients from the H-ADI group are likely to have lower overall long term survival in comparison to patients from the L-ADI group. Primary Endpoint: Patient survival over time. Hypothesis: Patients from the H-ADI group are likely to have higher prevalence of hemodialysis catheter placement as well as longer total duration of the catheter in comparison to patients from the L-ADI group. Primary Endpoint: Prevalence of hemodialysis catheter placement in both groups as well as total duration (in days) of catheter dependence in both groups prior to successful use of AVF/AVG. To determine long term survival of hemodialysis access patients in both groups Hypothesis: Patients in the H-ADI group will likely have lower fistula maturation rates as well as functional patency rates at 1 and 3 years in comparison to the patients in the L-ADI group. Primary Endpoint: Fistula maturation rate Secondary Endpoints: Number of procedures to attain maturity; functional patency at 1 and 3 years To determine the prevalence of hemodialysis catheter, use in both groups and compare total duration of catheter placement. Hypothesis: Patients from the highest quantile ADI score (those at the highest level of socioeconomic deprivation) are more likely to receive AVG as opposed to AVF. Primary Endpoint: Type of hemodialysis access in the highest quintile (H-ADI) vs the lowest four quintiles (L-ADI) To examine the outcomes and overall patency of hemodialysis access in patients of the highest quintile (H-ADI) vs the lowest four quintiles (L-ADI)
IRB No. 24-066-2 (Dr. Iman Al-Naggar, PI): Mito-LUTS: A Pilot Study of the Effect of MitoQ on Lower Urinary Tract Symptoms in Older Women with Metabolic Syndrome
Objectives: The goal of this pilot study is to serve as proof-of-concept that using MitoQ, a supplement with gerotherapeutics properties, to target shared biological pathways between aging, metabolic syndrome and lower urinary tract symptoms (LUTS) represents a much-needed novel direction in alleviating lower urinary tract symptoms. It will also help identify and validate biomarkers described in the literature for LUTS diagnosis and severity and generate data required to design and power future clinical trials. Aims: Aim 1: Elucidate the effect of MitoQ on lower urinary tract symptoms (LUTS) in older women with MetS. We will carry out a double-blinded, placebo controlled randomized pilot and exploratory study to test the effect of MitoQ on LUTS in older women with MetS. Older women (50-75 years) with both LUTS (no UTI, with urgency possibly accompanied by other symptoms such as frequency, urgency or urge incontinence for at least 3 months), and MetS (International Diabetes Federation (IDF) definition) will be randomized 2:1 into a treatment (40mg/day MitoQ, for 16 weeks) and placebo arm (Total number of participants will be 50). Assessments of LUTS using well-validated questionnaires and 3-day voiding diaries will be done at baseline, during, and at the end of the drug administration period. Main outcome will be change in LUTS questionnaire scores from baseline for each individual and between Placebo and MitoQ groups. We hypothesize that treatment with MitoQ will improve LUTS questionnaire scores in females with MetS, whereas the placebo group scores will remain unchanged or worsen Aim 2: Measure the effect of MitoQ on biomarkers and their biomarkers and their correlation with LUTS severity. There are currently no clinically useful biomarkers that are specific for LUTS, and novel biomarkers that can reliably distinguish LUTS are urgently needed. A good biomarker would also help with choice of therapy, predict response, change with an intervention and reflect changes in symptom severity. Aim 2a: Does treatment with MitoQ in females with MetS-related LUTS alter blood and urinary biomarkers of biological hallmarks of aging and LUTS? We will measure biomarkers of inflammation and oxidative stress in blood and urine at baseline and 16 weeks after treatment initiation in our participants. We will also measure urinary proteins and metabolites shown to correlate with overactive bladder syndrome (OAB) and others reported to be urotoxic or uroprotective. Values will be compared to baseline for each subject and means will be compared between groups. We hypothesize that MitoQ will reduce biomarkers of inflammation, oxidative stress, and OAB, while also decreasing urotoxic metabolites and increasing uroprotective metabolites. Aim 2b: Do changes in biomarkers correlate with types of LUTS and their severity? In order to be clinically useful, a biomarker should correlate well with LUTS type and severity. Biomarker levels will be correlated to LUTS questionnaire scores and voiding diary parameters. Because LUTS can have multifactorial etiology, no single biomarker has been useful. We aim to identify a panel of biomarkers for diagnosis, prognosis, tailoring, and tracking interventions. We hypothesize that changes in biomarkers will reflect changes in LUTS and correlate with LUTS severity. Study Design: This will be a randomized, placebo-controlled, double-blinded pilot and exploratory study. Participants in the MitoQ intervention group will receive MitoQ capsules (40 mg/day), whereas placebo control group will receive capsules containing all inactive ingredients prepared by the same manufacturer without the MitoQ, for 16 weeks.