Lower Urinary Tract Symptoms (LUTS)

Researchers are studying men with metastatic castration-resistant prostate cancer mCRPC to understand how different PETCT 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 PETCT 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 PETCT Axumin, 18F-DCFPyL PETCT, and 18F-FDG PETCT. 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 PETCT 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 used for treating men experiencing symptoms of Benign Prostatic Hyperplasia BPH. The study compares the FloStent implant procedure to a sham procedure without deploying the device. It involves men aged 45 and older with symptomatic BPH to better understand how this device may impact urinary symptoms. Participants will undergo a flexible cystoscopy procedure. Those randomized 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 deployment, serving as a sham treatment. The study is randomized, double-blind, and includes parallel groups to compare outcomes over time. Throughout the study, participants will be assessed on changes in their International Prostate Symptom Score IPSS over 12 months. Researchers will monitor symptom improvements at 3, 6, and 12 months to evaluate response rates. Participants will complete study visits and follow the protocol to help researchers gather data on the devices safety and impact on urinary symptoms.

Nocturia, a common and troubling condition among older adults in Taiwan, often disrupts sleep quality and affects mental health while increasing the risk of falls. This research evaluates a new community-based approach that combines digital health technology and behavioral therapy to manage nocturia in people aged 55 and older who experience two or more nighttime voids. The goal is to reduce nocturnal voiding frequency, improve quality of life, and explore reducing medication reliance. Participants are divided into two groups. The intervention group uses a non-contact home uroflowmetry device and a voiding diary to track urinary patterns, receiving real-time feedback. They also get personalized lifestyle advice such as fluid restriction and leg elevation, alongside psychiatric screening for sleep and mood disorders. The control group receives general health education and follow-up without these devices or personalized interventions. Throughout the study, participants record their voiding habits for 2-3 consecutive days monthly over six months. Researchers assess nocturnal void frequency, sleep quality, mental health, anxiety, quality of life, and fall or emergency events at the start, three months, and six months after randomization. This comprehensive monitoring helps evaluate the effectiveness of the community-based management model integrating digital tools and behavioral support.

This research evaluates the PureWick Urine Collection System as a non-invasive way to manage nocturia in women aged 50 and older. Nocturia, which involves waking at night to urinate, is common in older adults and increases the risk of falls and fractures. The study aims to assess whether using PureWick can reduce nighttime bathroom trips and improve sleep quality and overall life quality. Participants use the PureWick System, which includes an external catheter, tubing, and a collection canister. The device allows urine collection while remaining in bed, potentially lowering fall risk. The study is a single-group pilot conducted at one center, with follow-up lasting up to 3 months to observe urinary and sleep outcomes, as well as any related adverse events. During the study, participants are monitored for changes in the number of nocturia episodes, sleep quality via questionnaires, and other health factors such as urinary tract infections and skin condition. Data is collected at the start and after 3 months of device use. Researchers will measure how many patients achieve a 50% or greater reduction in nighttime urination, along with quality-of-life improvements and safety outcomes.

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 prevent bladder spasms after outpatient urologic surgery. This study focuses on patients undergoing bladder invasive procedures, aiming to compare magnesium treatment to a placebo to assess its preventive effects on post-operative bladder spasms. Participants will be randomly assigned to receive either intravenous magnesium or an equivalent volume of normal saline placebo during their urologic surgery. The magnesium is given as a loading dose of 50 mgkg followed by an infusion of 15 mgkghour. The trial uses a parallel design with quadruple masking to compare these treatments. During the study, participants will be monitored post-operatively for about 4 hours to assess the incidence and severity of bladder spasms, the need for treatment of spasms, and patient satisfaction. The primary outcome is the occurrence of bladder spasms approximately 1 hour after surgery. The research team will also track other outcomes at around 4 hours after surgery. The trial spans from July 2023 to December 2026.