Clinical Research Directory

The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy

The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.

Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction

It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.

Ambulatory Long Length URodynamics Evaluation

A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.

OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization

This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks

A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System

The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with BPH. Male subjects will be consented and undergo protocol-defined baseline assessments. Those who meet study entry criteria will be enrolled and treated with the ALPFA BPH PFA System and then undergo follow-up with protocol-defined assessment.

Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial

The goal of this randomized crossover clinical trial is to compare the efficacy and safety of Silodosin versus Tamsulosin in patients with moderate to severe lower urinary tract symptoms due to Benign Prostatic Hyperplasia. The main questions it aims to answer are: Does Silodosin provide superior improvement in symptom scores (IPSS) compared to Tamsulosin? Is there a difference in safety profile and adverse events between the two treatments? Researchers will compare both treatments in a crossover design, where each participant receives both medications in different periods without a washout phase, to evaluate individual response differences. Participants will: Receive both study medications in different periods according to random allocation. Undergo periodic assessment of urinary symptoms and quality of life. Perform routine follow-up evaluations including symptom scoring and urine flow measurements.

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Tranexamic Acid for Bleeding Reduction During TURP Surgery

Transurethral resection of the prostate (TURP) is commonly performed in elderly patients and may be associated with perioperative bleeding leading to postoperative anemia and delayed recovery. Tranexamic acid (TXA), an antifibrinolytic agent, may reduce surgical bleeding by inhibiting fibrin degradation. This prospective randomized quadruple-blind placebo-controlled clinical trial evaluates whether perioperative administration of intravenous tranexamic acid reduces intraoperative blood loss and preserves postoperative hemoglobin concentration in patients undergoing TURP under standardized spinal anesthesia. Participants are randomly assigned to receive either intravenous tranexamic acid or placebo prior to surgery. The primary outcomes assess objective measures of perioperative blood loss and postoperative hemoglobin levels. Secondary outcomes include recovery parameters, perioperative safety, and exploratory hospital-level economic impact. The study aims to determine whether anesthesia-led haemostatic optimization using tranexamic acid improves perioperative physiological stability and recovery efficiency within an enhanced recovery framework.

Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)

Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine. For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue. Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015. Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low. No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study. This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects

RADA16 for Aquablation Day Case

This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge. The primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation. The secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).

Urinary CTGF in Benign Prostatic Obstruction

Benign prostatic obstruction (BPO) is one of the most common causes of bladder outlet obstruction (BOO) and may lead to progressive structural and functional alterations in the bladder over time. Prolonged obstruction triggers a bladder remodeling process characterized by detrusor hypertrophy, ischemia-reperfusion injury, smooth muscle loss, and progressive fibrosis. These pathological changes may result in impaired detrusor contractility, increased post-void residual volume, and suboptimal functional recovery following surgical treatment. Connective tissue growth factor (CTGF) is a matricellular protein that plays a key role in fibrogenesis and is markedly upregulated under hypoxic, ischemia-reperfusion, and inflammatory conditions. Experimental and cellular studies have demonstrated that CTGF promotes fibroblast proliferation, extracellular matrix production, and collagen deposition, thereby contributing to bladder fibrosis. Increased CTGF expression has also been associated with fibrotic differentiation of bladder smooth muscle cells. The aim of this observational study is to evaluate the relationship between urinary CTGF levels, bladder fibrosis, and functional response to surgical treatment in patients with benign prostatic obstruction. Preoperative urinary CTGF levels will be assessed and correlated with postoperative functional outcomes and clinical improvement. This study aims to determine whether urinary CTGF may serve as a non-invasive biomarker of bladder fibrosis and a potential predictor of surgical treatment response in patients with BPO.

Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial

In a pilot study, water vapor therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure for benign prostatic hyperplasia, but often requiring oral ± intravenous sedation or a transrectal prostatic block. Therefore, pain management during Rezum therapy remains a challenge and may lead to the use of pain control protocols and general anesthesia, limiting in some ways the concept of a minimally invasive ambulatory surgical approach. The Schelin® catheter (ProstaLund AB, Lund, Sweden), approved by the European Medicines Agency, is a device for injecting analgesic drugs directly into the prostate via the trans-urethral route, providing more effective local anesthesia and avoiding the need for transrectal route or general anesthesia. This catheter is therefore of crucial importance in offering to our patients an ultra-minimally invasive treatment, associated with a reduction in room occupancy time, outpatient surgery time, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery. Our hypothesis is that the REZUM procedure under local anesthesia could be associated with a \>20% reduction in operating room occupancy time compared to procedures performed under general anesthesia.

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

Urinary Function and Multimorbidity Risks: A Longitudinal Study in Beijing Community-Dwelling Elderly

This study focuses on Beijing community residents aged 60 and above, aiming to understand how urinary function (like bladder or kidney function) and multiple health problems (such as high blood pressure, diabetes) affect each other as people age-since current studies often only look at single diseases and don't cover this group well. To join, participants need to be a 60+ Beijing community resident who can answer simple questions; those with serious mental illnesses or expected lifespan under 1 year can't take part. The study starts with a baseline check (asking about the participants' health, habits, doing blood/urine tests or urinary function assessments, and possibly collecting small blood/urine samples). After that, the investigators will follow up every 6-12 months (via phone or clinic to update health info) and repeat key checks yearly; people with lower cognitive ability will be checked every 3 months. The investigators will also record new illnesses, mobility issues (like falls), or death. The study has passed ethical review-participants will get clear info before joining, can quit anytime, and participants' data will stay private; participants will also get free health check reports and basic advice. For participants, this means regular health monitoring; for everyone, it'll help make tools to spot high-risk groups (like a community app), design better help (e.g., exercise plans), and push for yearly urinary health checks in communities.

A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate

This study will test whether a traditional Chinese medicine called Lingze tablets, when added to the standard drug tamsulosin, can better improve sleep and nighttime urination problems in men after prostate surgery. Who can participate? Men aged 50 years or older who have had transurethral holmium laser enucleation of the prostate (a minimally invasive surgery for enlarged prostate) and continue to have bothersome nighttime urination (at least 2 times per night) and other urinary symptoms may be eligible. Who cannot participate? Men who cannot tolerate the study medications, have severe cancer, serious organ failure, or have conditions that prevent them from understanding or following the study requirements. What will participants do? About 136 participants will be randomly assigned (by chance, like a coin flip) to one of two groups: Group 1: Take tamsulosin sustained-release capsule once daily for 8 weeks Group 2: Take tamsulosin sustained-release capsule once daily PLUS Lingze tablets (4 tablets, three times daily) for 8 weeks Participants will visit the hospital clinic at the start of the study, at 4 weeks, and at 8 weeks for assessments. What will be measured? Researchers will measure: How many times you wake up at night to urinate Overall sleep quality using standard questionnaires Prostate symptom scores and quality of life Urine flow tests (non-invasive) Anxiety levels Any side effects or adverse events from the medications Why is this study important? Many men continue to have nighttime urination and poor sleep even after prostate surgery, which can greatly reduce quality of life. This study will help determine if combining Lingze tablets with standard treatment provides better relief than standard treatment alone. Risks and Benefits: Potential benefits: Improved sleep, fewer nighttime bathroom trips, better urinary symptoms, and enhanced quality of life. Potential risks: Possible side effects include dizziness, headache, nausea, or stomach upset from the medications. All participants will be closely monitored for any problems and can contact the study team 24/7 with concerns. Privacy: All personal and medical information will be kept confidential and used only for research purposes in accordance with hospital and national regulations.

A Smart Wearable Device for Monitoring Urination Function in Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia (BPH) is a common condition that can cause bothersome urination problems and reduce quality of life. Accurately measuring how the bladder empties is important for diagnosis and treatment, but current methods like uroflowmetry can be inconvenient and are done only at a clinic. This study aims to test a new, non-invasive smart wearable device that uses Electrical Impedance Tomography (EIT) to monitor bladder function in patients with BPH. The device is worn on the lower abdomen. In this study, participants will use this EIT device while also undergoing the standard uroflowmetry test. The main goal is to see how well the measurements from the new device (like urine flow rate and volume) agree with those from the standard test. The study hopes to show that this wearable device can accurately and comfortably track bladder function over time. If successful, it could lead to a new tool for doctors to better monitor patients with BPH, even potentially at home.

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After Surgery for Benign Prostatic Hyperplasia.

This study aims to evaluate the effectiveness of pelvic floor muscle exercise (PFME) on improving lower urinary tract symptoms (LUTS), postvoid residual volume (PVR), and quality of life in patients undergoing surgery for benign prostatic hyperplasia (BPH). Patients who undergo BPH-related procedures, such as TURP or HoLEP, often experience postoperative symptoms including urinary urgency, frequency, nocturia, dribbling, and voiding difficulty, which may negatively affect daily living. Pelvic floor muscle exercise is believed to enhance urethral sphincter function and pelvic floor support, thereby improving urinary control. This randomized study assigns participants to either an intervention group receiving PFME training or a control group receiving standard postoperative care. Differences in urinary outcomes between groups will be compared. The findings are expected to provide an accessible and cost-effective rehabilitation strategy to support postoperative recovery and quality of life.

5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy

The study is being conducted to learn why some patients with Benign Prostatic Hyperplasia (BPH) do not respond to a commonly used treatment drug, Finasteride. The hope is to find ways to predict which patients will not respond to Finasteride so that, in the future, these patients can be identified prior to offering this treatment and they can be offered alternative treatment strategies in its place. The aim is to see if noninvasive techniques such as MRI can detect inflammation of the prostate to assist with early detection of those who will and who will not respond to Finasteride.

Comparing UroLift Experience Against Rezūm

C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.

A Clinical Trial to Evaluate the Safety and the Pharmacokinetics of AD-116 Compared to AD-1161 in Healthy Adult Male Volunteers

The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-116 and the administration of AD-1161 in healthy adult male volunteers