Kidney Stone

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 comparing the use of a Flexible and Navigable Suction Ureteral Access Sheath (FANS) with a traditional ureteral access sheath during retrograde intrarenal surgery (RIRS) for kidney and ureter stones. This randomized controlled trial aims to evaluate which method better aids in stone clearance while minimizing complications related to intrarenal pressure and residual stone fragments. The study addresses ongoing challenges in RIRS, such as managing intrarenal pressure and improving stone-free rates through technological advancements in access sheath design. The study involves two groups: one using FANS and the other using a traditional ureteral access sheath (UAS). After anesthesia, patients are positioned for surgery and their ureters are dilated. In the FANS group, a flexible suction sheath is navigated into the kidney to aspirate stone fragments during laser lithotripsy, while the traditional UAS group uses a fixed sheath positioned below the ureteropelvic junction. Both groups undergo laser treatment with irrigation pumps, and JJ stents are placed after the procedure. Participants will be monitored for stone clearance using imaging 12 weeks after surgery to measure the stone-free rate. The trial includes assessments of surgical effectiveness and potential complications related to ureteral access and stone removal. Patient health, urine infection status, and renal function are evaluated for eligibility, and the total duration of participation involves preoperative preparation, surgery, and follow-up assessments over several weeks.

Ureteric stents and catheters are commonly used to restore urinary drainage in patients with kidney stones or cancers pressing on the ureters. These devices often cause complications like inflammation, pain, and infections, which negatively affect quality of life and increase antibiotic use. Device-associated encrustation and biofilm formation lead to urinary tract infections in more than 90% of cases, causing stent blockages and contributing to antibiotic resistance. This research aims to study a novel ureteric stent designed to reduce these complications and improve patient outcomes, particularly in elderly and oncology patients. The trial evaluates an experimental ureteric stent with specially shaped side-holes that prevent low-flow areas where particles settle, reducing encrustation and biofilm formation. Patients with kidney stones or abdominal/pelvic cancers requiring stents will receive this novel stent instead of a conventional JJ stent. The stent will be removed after 4 weeks for kidney stone patients and after 25 weeks for oncology patients. Recruitment for the oncology group starts after reviewing kidney stone patient results. Additionally, qualitative interviews will be conducted with patients and doctors about their stent experiences. Participants will be monitored from enrolment until stent removal, with assessments of stent failure rates, extent of encrustation and biofilm, clinical outcomes, quality of life, and patient experiences. Questionnaires will be completed 2-3 weeks after stent removal. The study includes multiple visits and data collection to understand the impact of the novel stent. Researchers aim to reduce hospital admissions, improve quality of life, and decrease antibiotic use through this innovative device, with follow-up lasting up to 25 weeks for oncology patients.

Researchers are evaluating a new tool called VISOR in adults aged 18 to 80 who have kidney or ureter stones measuring 1 to 3 cm. The study aims to determine if VISOR is safe and effective in clearing stones during surgery by using its built-in features such as flushing, suction, pressure control, and stone-breaking and removal. The main questions are whether VISOR can clear stones successfully for at least 90% of participants within 24 hours after surgery, keep serious complications below 5%, and maintain safe pressure levels inside the kidney during the procedure. All participants will undergo stone removal surgery using the investigational VISOR device. This device integrates irrigation and suction with real-time pressure monitoring to keep kidney pressure below 30 mmHg during surgery. It uses a holmium laser to break stones while simultaneously removing fragments. After surgery, participants will have a CT scan within 24 hours to check if stones are cleared, followed by a follow-up imaging test (CT or ultrasound) around 4 weeks later to monitor any complications and the longer-term stone-free rate. Participants will be closely monitored during and after surgery with continuous pressure tracking and assessments for any ureteral injuries or infections. They will attend a follow-up visit about 4 weeks after surgery for imaging and health evaluation related to the procedure. Researchers will measure the immediate and 1-month stone-free rates, operative time, intraoperative kidney pressure, and rates of complications to evaluate the safety and effectiveness of VISOR. Total participation includes surgery, immediate post-op imaging, and follow-up within about one month.

Researchers are evaluating the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, comparing results with those from the FREEDOM substudy. This study focuses on women aged 60 to 90 years who have a BMD T-score between -4.0 and -2.5. It aims to assess ACC's impact both with and without the addition of Denosumab treatment, an osteoporosis therapy, in an open-label setting. Participants are assigned to one of two groups: the A arm includes women who meet National Health Insurance (NHI) criteria for Denosumab and receive 5 ACC tablets daily plus a 60 mg Denosumab injection every 6 months; the B arm includes women who do not meet NHI criteria or prefer not to receive Denosumab and take 5 ACC tablets daily only. All participants with certain vitamin D levels receive daily vitamin D3 supplements. The study spans 7 clinic visits over 24 months, including screening, treatment start, and follow-up visits. During visits, researchers perform BMD assessments and blood draws at baseline and months 1, 6, 12, and 24. They monitor changes in lumbar spine BMD as the primary outcome, along with overall BMD and bone turnover markers over 2 years. Participants are expected to comply with vitamin D intake limits and complete study procedures, allowing researchers to evaluate the effects of ACC with or without Denosumab on bone health.

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 comparing patient-reported outcomes for leaving out a stent versus placing a stent after using a ureteral access sheath during uncomplicated ureteroscopy for kidney or ureteral stones. This study evaluates pain interference and intensity as reported by patients, along with healthcare use within 30 days after the procedure. Participants will have a ureteral access sheath used during their ureteroscopy, with the sheath size decided by the surgeon. Ureteral injury will be assessed at the end of surgery using the Post Ureteroscopic Lesion Scale (PULS). Patients with low-grade injury (PULS 0 or 1) will be randomly assigned to either receive a stent or have no stent placed after the procedure. When stents are placed, the type and whether to leave a tether string will be determined by the surgeon. Participants will complete surveys before surgery and at several time points afterward, including daily up to 7-10 days or until stent removal, and again at 30 days. Researchers will collect data on pain, urinary symptoms, social activities, treatment satisfaction, days off work, and healthcare use. Medical records will also be reviewed, and safety and stone clearance will be monitored up to 60 days after the procedure.

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 studying catheter-related bladder discomfort (CRBD) that can occur after urinary catheter insertion during surgical procedures, particularly urinary interventions. This clinical trial evaluates the effects of adding dexmedetomidine or tramadol to paracetamol in managing CRBD and postoperative pain. The study is a randomized, triple-blind, phase 3 trial aimed at understanding how these drug combinations may reduce discomfort after surgery. Participants will be divided into two groups. One group will receive dexmedetomidine at 0.5 micrograms per kilogram combined with paracetamol at 10 milligrams per kilogram, while the other group will receive tramadol at 1 milligram per kilogram plus paracetamol at the same dose. These treatments will be administered during the surgical period to assess their effects on bladder discomfort and pain. During the study, researchers will monitor participants for 24 hours after surgery to measure the incidence of CRBD as the primary outcome. Secondary outcomes include evaluating postoperative pain, the need for additional pain medication (meperidine), and satisfaction levels of both patients and surgeons. The study involves adult male patients aged 20 to 50 years undergoing percutaneous nephrolithotomy (PCNL).

Researchers are studying whether taking alpha-blockers before flexible ureterorenolithotripsy helps in the easier placement of a ureteral access sheath during kidney stone surgery. This phase 4 randomized trial involves adults diagnosed with nephrolithiasis who need flexible ureteroscopy. The goal is to see if alpha-blockers improve surgical success and reduce the need for additional procedures while monitoring safety outcomes like ureteral injuries. Participants will be randomly assigned to one of two groups. One group will take an oral alpha-blocker (such as tamsulosin 0.4 mg) once daily for seven days before surgery to relax the ureteral muscles and assist sheath insertion. The other group will undergo the same surgery without preoperative alpha-blockers. Both groups will follow the same surgical protocols. During the study, participants will have their surgery and be assessed for successful ureteral sheath placement during the procedure. Researchers will also track any ureteral injuries and the need for further surgical interventions. The primary measure is the rate of successful sheath insertion without needing a second procedure. The study will include visits and monitoring before, during, and after the surgery, with total participation lasting through the surgical and immediate perioperative period.