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 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 treatments safety, tolerability, pharmacokinetics, and effectiveness against placebo when combined with an antibiotic, trimethoprimsulfamethoxazole TMPSMX. 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 TMPSMX over three days. Part 2 is a double-blind, randomized comparison of the selected LBP-EC01 dose regimen versus placebo, both with oral TMPSMX, in 288 patients. Treatment in Part 2 lasts three days, with doses given twice daily for TMPSMX 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 vaccines 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 studying men with non-metastatic prostate cancer who are receiving radiation treatment to find the preferred dose of lisinopril. The study aims to evaluate how lisinopril affects urinary symptoms and how it influences certain biomarkers related to these symptoms. This phase I trial focuses on prevention of urinary toxicity caused by radiation therapy. Participants will be given lisinopril tablets in escalating doses of 5 mg, 10 mg, and 20 mg once daily. The study includes a control group receiving radiation treatment without any intervention. The trial is randomized and sequential, allowing comparison between the groups to determine the best dose that may prevent urinary side effects after radiotherapy. During the study, participants will be monitored for changes in urinary symptoms using the Expanded Prostate Index Composite score over 12 months. Researchers will also track the percentage of patients with blood detected in urine and the proportion who tolerate the highest dose of 20 mg. The total study duration includes follow-up assessments to measure these outcomes and ensure safety, with the trial completion planned by 2028.

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 Zaviceftas approval to ensure ongoing safety and effectiveness monitoring in real-world settings.

Researchers are evaluating the use of D-mannose supplementation to prevent recurrent urinary tract infections rUTI in post-menopausal women. This randomized, double-blind, placebo-controlled study aims to improve understanding of rUTI prevention in this population, which is disproportionately affected and understudied. The study tests whether daily D-mannose intake over 6 months and up to one year effectively reduces the occurrence of uncomplicated rUTIs compared to placebo. Participants will be randomly assigned in a 21 ratio to receive either D-mannose 2 grams daily, taken as four 500 mg capsules or a placebo for 12 months. The study follows CONSORT guidelines and includes two groups one receiving the active supplement and the other receiving a placebo. The study aims to enroll 90 women who are currently free of UTI but have a history of recurrent infections. During the study, participants will attend follow-up appointments to monitor urinary tract health through urine cultures and symptom assessments. Researchers will collect data on failure rates, number of antibiotic treatments for UTI, symptom severity, and any serious adverse events related to D-mannose over an average follow-up of five years. This allows long-term observation of the supplements impact on rUTI prevention and safety.

Researchers are evaluating a new way to provide preoperative information to patients who are candidates for spinal or urological surgery. This study is an interventional, randomized controlled trial conducted at multiple centers. It aims to compare a new multimedia-based method that objectively checks patient understanding against the standard informed consent process to see which better supports patient decision-making about surgery. Participants in the experimental group will receive detailed information through videos with surgical options, graphics, and animations. They will also have interviews with the surgeon and caregivers using 3D-printed models to guide shared decision-making. After deciding on surgery, patients will join educational programs to reinforce understanding before a final surgeon interview and signing of informed consent. The control group will receive the usual care, including a standard explanatory interview and consent signing. Throughout the study, participants will complete questionnaires assessing satisfaction, comprehension, mental health, pain, disability, urinary and sexual function, and legal outcomes at multiple time points before surgery, at discharge, and at two and six months after surgery. The research team will monitor these measures to evaluate the impact of the new method on patient understanding and decision satisfaction over time.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.