Cystitis (Bladder Infection)

This research aims to improve the diagnosis of urinary tract infections (UTI) in older adults aged 65 years and above. It focuses on finding the best cut-off values for individual urine biomarkers such as NGAL, IL-6, AZU, TIMP2, and CXCL9, along with assessing the sensitivity, specificity, and predictive values of these markers. The study also seeks to validate urine leukocyte count cut-offs and evaluate the combination of biomarkers for better diagnosis. Additionally, it will explore how biomarker levels relate to symptom duration, complications, recurrence within two months, and hospital stay length. The performance of the astrego PA100 device in detecting bacteriuria will also be validated. Participants will provide a midstream urine sample once at the start of the study, which will be collected in a sterile container for biomarker testing. They will answer questions about their symptoms and general health at the beginning and again after eight weeks. Vital signs, including temperature and blood pressure, will be measured once at the start. This observational study does not involve any treatment but focuses on diagnostic assessments. During the study, participants will be monitored for symptoms and potential complications. Researchers will track symptom duration, hospital stay lengths, and recurrence of UTI over an eight-week period. Diagnostic accuracy of individual biomarkers and their combinations will be evaluated at baseline. The study will also assess the diagnostic performance of the PA100 device for bacteriuria detection. Overall participation involves two assessments and one urine sample collection, spanning about eight weeks from inclusion to follow-up.

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

Researchers are evaluating the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) to help diagnose bladder cancer by comparing it with standard clinical methods such as medical imaging, cystoscopy, and pathological examination. The study includes participants diagnosed with or suspected of bladder cancer, those at high risk, or those with symptoms or other conditions that might be confused with bladder cancer. The goal is to assess the safety and effectiveness of this urine DNA testing kit. Participants will provide urine specimens for testing with the Human Multigene Methylation Detection Kit, and will also undergo examinations using the standard clinical methods. The study involves two groups of participants: one with bladder cancer and one without. Technical staff evaluating the urine test results will be blinded to the clinical diagnosis results. The study is observational and single-blinded. During the study, participants will provide urine samples and undergo medical imaging, cystoscopy, or pathological examination as needed. Researchers will compare the urinary test results with clinical findings to analyze sensitivity, specificity, consistency rate, and agreement (Kappa Coefficient) over one year. Participants' involvement includes specimen collection and standard diagnostic procedures, with safety and diagnosis effectiveness monitored throughout the study period.

This research aims to evaluate a new approach for preventing recurrent urinary tract infections (UTIs) in children and adolescents aged 2 to 17 years. It compares the use of a probiotic called Saccharomyces Boulardii combined with an antibiotic, ciprofloxacin, given when a UTI occurs, against standard care treatments. The study focuses on patients with a history of multiple UTIs and certain urinary tract conditions, aiming to reduce the number of UTI episodes over six months. Participants will receive the probiotic Saccharomyces Boulardii once daily for six months regardless of symptoms. At enrollment, all participants will be provided with ciprofloxacin. Those who have UTI symptoms or a positive urine culture at the start will take ciprofloxacin every 12 hours for 14 days. Those without symptoms will take the antibiotic only if a UTI occurs later. All participants will continue to receive standard clinical care, including management of bowel and bladder function and other non-antibiotic treatments as determined by their healthcare providers. Throughout the study, participants will be monitored for UTI episodes, with the primary outcome being the reduction in UTI episodes over six months. Researchers will track adherence to the probiotic and antibiotic regimens and standard care practices. Safety and tolerability will be observed, and participants’ health will be assessed through clinical visits and urine cultures as needed. The study duration and follow-up ensure careful observation of the treatments’ effects and participants’ well-being.

This research focuses on adult patients with sepsis caused by abdominal infections, aiming to understand the progression of entero-renal syndrome. The study compares patients who survive with those who do not by examining gastrointestinal function, blood flow in the superior mesenteric artery, and the renal artery resistance index. Researchers seek to provide reliable information to improve clinical decision-making and rescue success rates. Participants undergo ultrasound examinations to measure the gastric antrum cross-sectional area, colon diameter, colon peristalsis frequency, and renal artery resistance index. These measurements are taken at multiple time points: upon ICU admission, and then 6, 24, 48, 72, and 120 hours later. Additional monitoring includes central venous pressure, oxygen saturation, inflammatory markers, blood lactic acid, blood creatinine, fluid intake, and bladder pressure. During the study, participants are monitored closely in the ICU with data collected to assess survival outcomes. The main outcome measures focus on the resistance indices of the superior mesenteric artery and renal artery at admission and at 24 and 72 hours post-admission. This observational study extends up to 120 hours with ongoing assessments to better understand the syndrome’s progression and support clinical care for sepsis patients.

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for women with acute uncomplicated urinary tract infections (UTI) caused by drug-resistant E. coli. The study aims to find the best dosing regimen and compare the treatment's safety, tolerability, pharmacokinetics, and effectiveness against placebo when combined with an antibiotic, trimethoprim/sulfamethoxazole (TMP/SMX). Eligible participants must have an active acute UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts. Part 1 is an open-label dose regimen selection with 30 patients divided into three groups receiving different doses of LBP-EC01 via intraurethral and intravenous administration alongside oral TMP/SMX over three days. Part 2 is a double-blind, randomized comparison of the selected LBP-EC01 dose regimen versus placebo, both with oral TMP/SMX, in 288 patients. Treatment in Part 2 lasts three days, with doses given twice daily for TMP/SMX and specified LBP-EC01 doses on days 1 to 3. Participants will provide urine, blood, and stool samples for microbiological and pharmacokinetic analyses. Researchers will monitor clinical symptoms, microbiologic responses, adverse events, and immunogenicity over several follow-up visits up to six months. The main outcomes include drug levels in urine and blood, symptom resolution, and microbiological cure by day 10. Safety and tolerability are also closely observed throughout the study.

Researchers are conducting an international, multicenter observational study to understand how patients admitted to hospitals with emergency haematuria are managed. The study aims to identify variations in care, measure outcomes like length of hospital stay, mortality, readmission rates, and resource use, and support the development of future guidelines and trials to improve haematuria management. The study collects detailed data on patient demographics, underlying health conditions, diagnostic procedures, treatments, and outcomes using a standardized form. It includes patients admitted as emergencies with haematuria under urology care. The study observes current hospital management pathways and gathers information through questionnaires to participating sites. Participants will be followed during their hospital stay and for 90 days afterward. Researchers will evaluate length of stay, time to diagnosis, mortality at 30 and 90 days, readmissions, days alive and out of hospital, and healthcare costs. The study uses data analysis to assess factors linked to outcomes and variations in care. Participation involves no changes to treatment as it is observational, and data will be collected consecutively over a 12-month period from multiple centers.

Researchers are evaluating the safety, immune response, and preliminary clinical efficacy of a candidate vaccine for urinary tract infections (UTIs) in adults aged 18 to 64 years. This trial focuses on adults generally for safety and immune response, and specifically on females with a history of at least one confirmed E. coli UTI within the past year for clinical efficacy. The study includes two parts: an initial dose-escalation safety phase and a proof-of-principle efficacy phase, designed to establish the highest tolerated dose and evaluate the vaccine's impact on UTI occurrence. Participants receive one of several vaccine dose formulations or placebo administered by injection on Day 1 and Day 61. Part 1 involves healthy male and female adults and tests increasing antigen doses for safety. After safety review, Part 2 enrolls females with previous E. coli UTIs to assess vaccine efficacy compared to placebo over a 12-month period. The vaccine is given intramuscularly following a 0 and 2 months schedule. Throughout the study, participants are monitored for side effects at the injection site and systemic reactions during the first week after each dose, as well as for any adverse events up to 426 days from the first dose. Blood tests, pregnancy monitoring, and clinical exams are conducted. The main outcome measures include the frequency of adverse events and the rate of urine culture confirmed UTIs in females during the follow-up period. Participants are followed closely for safety and immune response, with the trial lasting over a year from initial vaccination.

Researchers are evaluating the preferred dose of lisinopril in men with non-metastatic prostate cancer who are undergoing radiation treatment. The study aims to assess how lisinopril affects urinary symptoms and biomarkers related to these symptoms during and after radiation therapy. This is an early phase 1, randomized trial sponsored by the University of Rochester. Participants will either receive radiation therapy alone or radiation combined with lisinopril tablets at escalating doses of 5 mg, 10 mg, or 20 mg taken once daily. The study compares these groups to understand the optimal lisinopril dose for preventing urinary toxicity after radiotherapy. Radiation may be given as primary, adjuvant, or salvage treatment, possibly with androgen deprivation therapy. During the 12-month study, researchers will monitor urinary symptoms using the Expanded Prostate Index Composite score and measure the presence of blood in urine. They will also track how many participants reach the 20 mg lisinopril dose. Participants will undergo assessments including blood tests and evaluations of kidney, liver, and blood function. The study includes follow-up to evaluate the safety and effects of lisinopril on urinary health after radiation treatment.

Researchers are evaluating the safety and effectiveness of Zavicefta in patients with difficult infections in the abdomen, urinary tract, and pneumonia, including infections possibly acquired during hospital stays. This observational study follows regulations by the Ministry of Food and Drug Safety (MFDS) in Korea and focuses on real-world use after Zavicefta is released in the Korean market. The study aims to collect data on adverse events and treatment responses during routine clinical practice. The study involves patients who have been given at least one dose of Zavicefta for approved infections such as complicated intra-abdominal infection, complicated urinary tract infection including pyelonephritis, hospital-acquired pneumonia including ventilator-associated pneumonia, and other infections caused by aerobic Gram-negative bacteria with limited treatment options. Patients receiving Zavicefta for the first time are included. The study period covers monitoring from the first dose and continues for at least 28 days post-treatment, with follow-up up to one year for clinical response assessment. Participants will be observed during their usual medical care while data is collected on any adverse events or drug reactions, including both expected and unexpected effects. Researchers will track the number of patients reporting adverse events and evaluate treatment outcomes such as clinical cure rates. This post-marketing surveillance study continues for six years after Zavicefta's approval to ensure ongoing safety and effectiveness monitoring in real-world settings.