Bladder Disorder

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

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.

Bladder cancer is a common type of cancer, especially in men, and most cases are non-muscle invasive at diagnosis. When it progresses to muscle-invasive bladder cancer, treatment usually involves chemotherapy followed by surgery called radical cystectomy with urinary diversion. Despite surgical advances, complications after this surgery remain frequent. The role and timing of ureteric stenting during this surgery to prevent urinary leakage and obstruction is uncertain, and prior studies have shown mixed results regarding its benefits and risks. This study is a randomized trial comparing early versus late removal of ureteral JJ stents after radical cystectomy and ileal conduit formation. Participants will be assigned to either have their stents removed early, between 5 and 7 days after surgery, or late, between 4 and 6 weeks after surgery. The study aims to assess the feasibility of conducting a larger definitive trial by evaluating complication rates and other outcomes related to the timing of stent removal. Participants will be monitored for complications within 30 days, 90 days, and up to one year after surgery. The study will also track readmission rates and feasibility outcomes over one year. Researchers will collect data on surgical complications and recovery, with no blinding involved. The total duration of participation varies, with follow-up visits to assess the effects of early versus late stent removal on patient outcomes.

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 compare the safety and effectiveness of three different endoscopic techniques for removing large prostate tissue in men with benign prostatic hyperplasia (BPH) who experience severe urinary symptoms. The study focuses on men with prostate sizes over 100 mL who have not responded to medical treatments and have significant symptoms measured by the International Prostate Symptom Score (IPSS) and urinary flow rates. The trial is a prospective randomized controlled study conducted at Tanta University Hospital, evaluating three surgical methods used to treat large prostates causing lower urinary tract symptoms. Participants will be randomly assigned to one of three groups, each undergoing a different prostate enucleation procedure: Thulium Fiber Laser Enucleation (ThuFLEP) using a 60W thulium fiber laser, Holmium Laser Enucleation (HoLEP) using a 150W holmium YAG laser, or Bipolar Transurethral Enucleation (B-TUEP) using bipolar electrical energy. All procedures are performed transurethrally and involve removing the prostate tissue with a morcellator. Each group will have 30 patients, and the study will run from October 2025 to October 2027. Participants will undergo thorough preoperative assessments including symptom scores, urinary flow tests, ultrasounds, blood tests, and prostate-specific antigen measurements. After surgery, follow-ups at 1, 3, and 6 months will evaluate symptom relief, quality of life, urinary flow rate, residual urine volume, and erectile function. Researchers will also track operative times, blood loss, catheter duration, hospital stay, and complications categorized by the Clavien-Dindo system. The study measures both patient outcomes and surgical efficiency over six months post-operation.

This research aims to assess the long-term safety and effectiveness of the FDA-approved eCoin4 implanted tibial nerve stimulator in people with overactive bladder (OAB) who experience urgency urinary incontinence (UUI). The study is prospective, involves multiple centers, and follows a single group of participants to understand how the device performs in real-world use. Participants will receive an implant of the eCoin device, which provides subcutaneous stimulation to the tibial nerve. This stimulation is intended to help manage urgency urinary incontinence. The treatment involves implanting the device and then monitoring participants over time to evaluate its safety and effectiveness. Throughout the study, participants will complete voiding diaries and quality of life questionnaires during follow-up visits that extend up to 5 years. Researchers will monitor safety by tracking any device- or procedure-related adverse events and measure effectiveness by assessing responder rates at 12 and 24 months. The study includes ongoing evaluations of safety data even after reimplantation when applicable, ensuring comprehensive long-term monitoring.

Researchers are evaluating whether intravenous magnesium can help treat bladder spasms that occur after urologic surgery. This Phase 2 clinical trial compares magnesium infusion to a placebo in adults undergoing bladder invasive procedures, aiming to better understand its impact on post-operative bladder spasms. Participants will be randomly assigned to receive either an intravenous magnesium infusion or an equivalent volume of normal saline (placebo) during their urologic surgery. The magnesium dose includes a loading infusion of 50 mg/Kg followed by 15 mg/Kg per hour. The study is quadruple-masked to keep participants and researchers unaware of the assigned treatment during the surgery. During the study, researchers will monitor the incidence and severity of bladder spasms approximately 1 and 4 hours after surgery. They will also assess treatments used for spasms and patient satisfaction about 4 hours post-operation. The trial involves outpatient procedures and aims to complete by the end of 2026, with careful safety and effectiveness monitoring throughout.

Researchers are evaluating the safety, effectiveness, and how the body processes the drug vibegron in children aged 2 to less than 18 years who have neurogenic detrusor overactivity (NDO) and who regularly use clean intermittent catheterization (CIC). This study includes pediatric participants with NDO due to conditions like spinal dysraphism or acquired causes and aims to gather long-term safety and efficacy data. Participants are divided into two groups based on age: those aged 12 to less than 18 years and those aged 2 to less than 12 years. Both groups receive vibegron orally once daily, with doses adjusted according to weight and individual responses, including possible dose reductions up to two times. The study includes two parts: Part A involves initial dosing and monitoring, while Part B administers a dose selected by a safety board based on Part A data. Throughout the study, participants will be monitored with various assessments including bladder function tests, catheterized urine volume measurements, and questionnaires about incontinence and symptoms. These evaluations occur at multiple time points up to 52 weeks, with the primary outcome focused on changes in bladder capacity at 32 weeks. Safety and tolerability are also closely followed during the study, which may last several months for each participant.

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 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.