Lower Urinary Tract Symptoms (LUTS)

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.

This research aims to evaluate whether adding a traditional Chinese medicine called Lingze tablets to the standard drug tamsulosin can better improve sleep quality and reduce nighttime urination problems in men who have undergone transurethral holmium laser enucleation of the prostate, a minimally invasive surgery for enlarged prostate. Many men continue to experience bothersome urinary symptoms and poor sleep after surgery, which can significantly affect their quality of life. This trial compares standard treatment to a combination approach to see if the addition of Lingze tablets offers added benefits. Participants will be randomly assigned to one of two groups. One group will take tamsulosin sustained-release capsules (0.2 mg) orally once daily at bedtime for 8 weeks. The other group will take the same tamsulosin dose plus Lingze tablets (4 tablets, three times daily) for 8 weeks. Lingze tablets are herbal-based and thought to support kidney function and clear bodily dampness and heat according to traditional Chinese medicine. Both groups will receive standard postoperative care guidance on diet, fluid intake, and activity. During the study, participants will visit the clinic at the start, 4 weeks, and 8 weeks for assessments. They will complete questionnaires on urinary symptoms, sleep quality, anxiety, and quality of life. Non-invasive urine flow tests and bladder ultrasounds will measure urinary function. Medication adherence and any side effects will be monitored. The primary outcome is the change in nighttime urination frequency over 8 weeks, with secondary outcomes including sleep quality and symptom severity. Safety and privacy are carefully maintained throughout the study.

This research aims to evaluate the safety and effectiveness of the FloStent, a medical device designed to treat men with symptoms of Benign Prostatic Hyperplasia (BPH). The study is a randomized, double-blind clinical trial comparing the FloStent to a sham procedure without device deployment. It focuses on men aged 45 years and older who experience urinary symptoms related to BPH. Participants will undergo a flexible cystoscopy procedure. Those assigned to the treatment group will receive the FloStent implant during this procedure, while those in the control group will have the cystoscopy without the implant being deployed. The study involves close monitoring over a 12-month period to assess changes in urinary symptoms. Throughout the study, participants will be evaluated using the International Prostate Symptom Score (IPSS) at various intervals, including 3, 6, and 12 months. This scoring system helps measure symptom changes over time. Researchers will also monitor safety and treatment responses. Participants can expect scheduled visits and assessments to track outcomes related to urinary function and device safety during the study duration.

Researchers are collecting information from women who have pelvic organ prolapse (POP) and are treated with trans-vaginal mesh surgery. This hospital-based, multi-center study aims to observe and record postoperative complications, especially mesh exposure or erosion, using an international classification system. The study includes patients from 41 centers across China and will track outcomes over 12 and 36 months after surgery to understand current practices and complication rates in this population. Participants receive pelvic floor reconstructive surgery using either commercial mesh kits or self-cut synthesized mesh through the vagina. The study observes these patients without altering their treatment choice, focusing on how the surgery is performed and its results. Follow-up assessments occur at various points up to three years after surgery, including evaluations at 6 weeks, 3 months, 1 year, and annually to monitor anatomical cure rates and complications. During the study, participants will complete questionnaires about their pelvic health and sexual function using tools like POP-Q, PGI-I, PFDI-20, PFIQ-7, and PISQ-12 at scheduled visits. Researchers will review complication rates at 12 and 36 months while examining changes in symptoms and quality of life. Participants are expected to provide contact information for follow-up and complete online surveys through WeChat. The total follow-up lasts for 36 months after surgery, with ongoing data collection to better understand long-term outcomes and management of trans-vaginal mesh procedures.

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 evaluate the Beacon Platform, a robotically assisted surgical device, for treating benign prostatic hyperplasia (BPH) in men. The study focuses on observing the outcomes of the Holmium Laser Enucleation of the Prostate (HoLEP) procedure using this platform. It is a prospective, multicenter, open-label pilot study designed to gather information on both intraoperative and postoperative results. Participants will undergo the HoLEP procedure assisted by the Beacon Platform, which allows the urologist to control surgical instruments through software during transurethral, endoscopic surgery. This single-arm study monitors the procedure without comparing to other treatments. The study tracks outcomes such as successful completion of the robot-assisted surgery without conversion and adverse events occurring up to 30 days after the procedure. During the study, participants will be closely monitored for safety and effectiveness through various assessments, including length of hospital stay, catheterization duration, operative time, and any complications such as perforations or damage requiring intervention. Researchers will also observe hospital readmissions related to genitourinary conditions within 30 days following the surgery. Participant involvement includes signing informed consent, undergoing the procedure, and completing follow-up evaluations until the study concludes.

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.