Clinical Research Directory

Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.

A prospective, randomized, double-blinded controlled trial to evaluate the efficacy of a 2-week preoperative and 2-week postoperative course of oral dutasteride (0.5 mg daily) in reducing perioperative blood loss, irrigation requirements, and catheterization time in patients on anticoagulant therapy undergoing bipolar TURP for benign prostatic hyperplasia (BPH).

Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH

Benign prostatic hyperplasia (BPH) is a common non-cancerous enlargement of the prostate gland in aging men that causes bothersome lower urinary tract symptoms (LUTS), including frequent urination, weak urinary stream, and difficulty emptying the bladder. Prostatic artery embolization (PAE) is a minimally invasive, image-guided catheter procedure that blocks blood flow to the prostate, leading to gland shrinkage and symptom relief. While traditional PAE utilizes particulate agents, N-butyl cyanoacrylate (NBCA / Histoacryl) glue is a liquid embolic material that may offer advantages such as shorter procedural duration, lower radiation exposure, and permanent vascular occlusion. The purpose of this prospective, single-arm study is to evaluate the feasibility, safety, and clinical efficacy of using Histoacryl glue mixed with Lipiodol (1:8 dilution ratio) during prostatic artery embolization in men with symptomatic BPH who have failed or cannot tolerate medical therapy. All enrolled participants will undergo PAE with the Histoacryl glue mixture. Participants will be monitored for procedural safety and followed up at 1 month and 3 months post-procedure. Follow-up assessments include urinary symptom improvement using the International Prostate Symptom Score (IPSS), quality of life (QoL) ratings, post-void residual urine volume, prostate-specific antigen (PSA) levels, pelvic imaging to measure prostate volume reduction, and monitoring for any procedure-related complications.

Comparing Rezum and Urolift

This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or prostatic urethral lift (UroLift) arm.

Waterjet Prostate Ablation

Introduction Men with enlarged prostates commonly experience lower urinary tract symptoms and may go on to develop complications such as acute urinary retention (AUR). Surgery is the standard treatment option required to remove the enlarged prostates and to rectify such complications. Transurethral resection of prostate (TURP) was first performed over 80 years ago and is still regarded as the "gold standard" for the treatment of benign prostatic enlargement (BPE) in prostates between 30 and 80ml. While TURP results in an improvement in symptoms, perioperative morbidity and long-term complications can include postoperative bleeding, urinary retention, incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction. Aquablation, a novel minimally invasive water ablation therapy combining image guidance and robotics (AQUABEAM®, Procept BioRobotics, Redwood Shores, CA, USA) for the targeted and heatfree removal of prostate tissue is one of the efforts in the development of new technology in recent years to replicate the effectiveness of TURP and at the same time with an improved safety profile. In this study, investigators plan to evaluate the feasibility and safety of Aquablation in the management of AUR secondary to BPE. Method 20 participants are expected in this study. After patients consent to participate in the study, they will go through Aquablation under general anaesthesia or spinal anaesthesia. The ablation is delivered by transurethral means. After the procedure, subject is expected to go home on the following day. Subject will be assessed 3 months and 6 months after the procedure. Follow-up assessment includes blood tests, prostate ultrasound and urodynamic study.

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.

Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate

Bipolar enucleation of the prostate is an effective operation for men with urinary obstruction caused by a benign enlarged prostate. Some men leak urine for a period after the operation. Early apical release is a surgical step that frees the tip (apex) of the prostate at the start of the operation to reduce stretch on the urinary sphincter. The conventional technique cuts all the way around the apex, including the front (anterior) tissue next to the sphincter. This randomized trial compares a modified technique, Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR), with conventional early apical release. ABP-S-EAR leaves the front tissue bridge between the 11 and 1 o'clock positions intact. Men aged 45 to 80 years scheduled for bipolar enucleation at Benha University Hospital, Egypt, will be randomly assigned to one technique. The main question is whether ABP-S-EAR improves urinary continence 1 month after surgery. The trial also compares patient-reported leakage, operative time, bleeding, catheter time, hospital stay, urinary symptoms, urine flow, and complications over 12 months.

Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate

Holmium laser enucleation of the prostate (HoLEP) is an effective operation for men with urinary obstruction caused by a benign enlarged prostate. Some men leak urine for a period after the operation. Early apical release is a surgical step that frees the tip (apex) of the prostate at the start of the operation to reduce stretch on the urinary sphincter. The conventional technique cuts all the way around the apex, including the front (anterior) tissue next to the sphincter. This randomized trial compares a modified technique, Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR), with conventional early apical release during HoLEP. ABP-S-EAR leaves the front tissue bridge between the 11 and 1 o'clock positions intact. Men aged 45 to 80 years scheduled for HoLEP at Benha University Hospital, Egypt, will be randomly assigned to one technique. The main question is whether ABP-S-EAR improves urinary continence 1 month after surgery. The trial also compares continence at 3, 6, and 12 months, operative time, bleeding, catheter time, hospital stay, urinary symptoms, urine flow, and complications.

Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong

This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters.

A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)

Benign prostatic hyperplasia (BPH), also known as an enlarged prostate, happens more often in men as they age. This condition causes a sudden need to pass urine, which is hard to control. Men with an enlarged prostate may need to pass urine many times during the day and night which can affect their wellbeing. There are treatments available, like tamsulosin but they don't work well in some men and can cause further health problems. Vesomni is approved in South Korea to treat urinary symptoms in men with an enlarged prostate, when treatment with tamsulosin doesn't work well enough. This study will track the safety of Vesomni given to men in South Korea who have moderate to severe symptoms from an enlarged prostate, who have previously been treated with tamsulosin and found it didn't work well. The safety of Vesomni is tracked by mainly collecting information from their medical records. The sponsor will ask for extra information to be collected, and if any health problems were caused by Vesomni. In this study, researchers want to learn about the safety of Vesomni and how well it controls symptoms in men with an enlarged prostate. The men's own doctor decides on treatment, as part of routine clinical practice, not the sponsor (Astellas). This study is about collecting information only. Most information about the safety and control of symptoms will be collected from medical records. The sponsor will also ask for extra information to be collected. All information will be collected for up to 24 weeks after the men start treatment with Vesomni.

Emsella for Reducing tSUI After HOLEP

This study aims to investigate the effectiveness of the Emsella chair treatments at different timepoints. Before and after the holmium laser enucleation of the prostate (HoLEP).

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.

Moses 2.0 vs Magneto for HoLEP - a Randomized Controlled Trial

The objective of this study is to compare the Magneto 150 holmium laser to the current MOSES 2.0 technology to see if there is a benefit in decreased hemostasis time intraoperatively.

Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia

This clinical trial focuses on men with benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate causes urinary problems. The goal is to test a non-thermal ablation technique called irreversible electroporation (IRE), delivered with a steep pulse therapy system, for treating BPH. The main questions it aims to answer are: 1. How many participants have improved urine flow 3 months after treatment? 2. How do urinary symptoms, quality of life, and prostate size change after treatment? 3. What side effects occur, and how serious are they? Participants will be asked to: * undergo the IRE procedure: needle electrodes are placed in the prostate through the perineum under ultrasound guidance, and short electric pulses ablate the enlarged tissue; * attend follow-up visits at 1 and 3 months after the procedure for urine flow tests, symptom questionnaires, and ultrasound measurements.

Ultrasound-Guided vs. Conventional Prostate Suspension in BPH: An Exploratory Study

This is an exploratory, prospective, single-center, open-label, 1:1 randomized controlled study. The study compares two surgical methods for benign prostatic hyperplasia (BPH): ultrasound-guided prostate suspension and conventional prostate suspension. BPH is a common condition in older men that can cause lower urinary tract symptoms (LUTS), such as frequent urination, weak urine stream, and difficulty emptying the bladder. The purpose of this study is to learn whether using ultrasound guidance during prostate suspension can improve urinary symptoms and urine flow more than the standard procedure, while preserving sexual function and maintaining safety. About 20 men aged 50-80 years with BPH and bothersome LUTS will be enrolled. Eligible participants must have an IPSS score of 12 or higher, a maximum urine flow rate (Qmax) of 15 mL/s or less, a prostate volume of 30-100 mL, and a post-void residual urine (PVR) of 250 mL or less. They must be dissatisfied with medication or refuse long-term medication and be able to give informed consent. Men with prior prostate surgery, suspected or confirmed prostate cancer, neurogenic bladder, urethral stricture, bladder neck contracture, bladder stones, recurrent urinary tract infection, active urinary infection, bleeding disorders, acute urinary retention, or current participation in another interventional trial cannot take part. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group will receive ultrasound-guided prostate suspension. In this procedure, the standard UroLift prostate suspension is performed with ultrasound guidance, and at least one additional suspension implant is placed on each side. The control group will receive the standard NeoTract UroLift System procedure. Both procedures are minimally invasive and are performed through the urethra without cutting prostate tissue. The study is open-label, meaning participants and surgeons know which procedure is used, but the staff who assess outcomes will be blinded to group assignment to reduce bias. The main outcome is the change in IPSS at 12 months after surgery. Secondary outcomes include changes in Qmax, quality of life (IPSS-QoL), PVR, sexual function (IIEF-5), complications, and retreatment rate. Follow-up visits will occur at about 1, 3, 6, and 12 months after surgery. The total study duration is about 36 months. All surgery has risks. Possible risks include bleeding, infection, pain, urinary symptoms, urinary retention, implant-related problems, or the need for further treatment. The study team will monitor participants closely and provide standard medical care as needed. This study may help doctors understand whether ultrasound-guided prostate suspension offers better symptom relief than the standard procedure. Participation is voluntary, and participants may withdraw at any time without affecting their usual medical care.

PRescription Exercise for Older Men With Urinary Disease

This is a single-center pilot randomized controlled trial among 68 physically "inactive" older men with lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (LUTS/BPH) assessing a 12-week remote exercise intervention versus health education control.

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.

Optimization of Surgical Treatment Pathways for BPH Based on Real-World Data

Benign prostatic hyperplasia is a noncancerous enlargement of the prostate that can cause difficulty urinating. Holmium laser enucleation of the prostate (HoLEP) uses a laser to remove prostate tissue blocking urine flow. Some patients experience stress urinary incontinence after surgery, meaning urine leakage during activities such as coughing, sneezing, or physical exertion. This may be related to temporary dysfunction or injury of the muscle that controls urine release. This single-center, prospective randomized study compares three HoLEP techniques in men aged 50-85 years with benign prostatic hyperplasia: conventional HoLEP without apical pre-disconnection; HoLEP with apical pre-disconnection at a fixed 12 o'clock location; and HoLEP with MRI-guided individualized apical pre-disconnection. Apical pre-disconnection involves separating the urethral lining near the tip of the prostate before the main tissue removal step. In the individualized group, preoperative magnetic resonance imaging (MRI) is used to tailor the separation site to each patient's anatomy. The study tests the hypothesis that MRI-guided individualized apical pre-disconnection reduces postoperative stress urinary incontinence and improves early urinary control and quality of life compared with the other two techniques, while maintaining the improvement in urination achieved by HoLEP. Participants are randomly assigned to one of the three surgical groups and assessed at 1 week, 1 month, and 3 months after surgery. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) total score at 3 months. This questionnaire measures the frequency and amount of urine leakage and its impact on daily life. Secondary outcomes include ICIQ-UI-SF scores at 1 week and 1 month, and quality of life, urinary symptoms, maximum urine flow rate, and postvoid residual urine volume at all three follow-up visits. Postoperative complications are also recorded and compared among groups.

Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia

Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia

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.

Modified SOLTIVE Study

This is a study to collect procedural data during the use of the SOLTIVE™ Premium SuperPulsed Laser System in the treatment of bladder, ureteral, and kidney stones and BPH to inform the development of software algorithms.

Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients With Benign Prostatic Hyperplasia-related Obstruction

The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.

Ultrasound IPP to Predict Response to Medical Therapy in LUTS/BPH

This prospective cohort study evaluated whether transabdominal ultrasound measurement of intravesical prostatic protrusion predicts symptom severity and response to medical therapy in men aged 50 years or older with lower urinary tract symptoms secondary to benign prostatic hyperplasia. At baseline, participants underwent clinical evaluation, laboratory assessment including prostate-specific antigen, symptom scoring using the International Prostate Symptom Score and quality of life index, uroflowmetry, and transabdominal ultrasonography to measure prostate volume, bladder parameters, post-void residual urine, detrusor wall thickness, and intravesical prostatic protrusion. Participants were grouped by intravesical prostatic protrusion grade (less than 5 millimetres, 5 to 10 millimetres, and greater than 10 millimetres) and were followed for six months with reassessments at three and six months to evaluate response to medical therapy and identify patients who required escalation of treatment or surgical intervention.

Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Prostate Cancer

This prospective study aims to validate the clinical outcomes of performing a concomitant trans-perineal prostate biopsy and laser ablation (termed "Bioblation") during a single session. The intervention is designed for symptomatic patients presenting with lower urinary tract symptoms (LUTS) who are highly suspected to have low to favorable intermediate-risk prostate cancer. By combining diagnosis and targeted treatment under local anesthesia, this approach seeks to facilitate early relief of severe symptoms and a rapid return to daily activities. Ultimately, the study evaluates whether this combined procedure decreases the patient's exposure to multiple, temporally separated interventions without compromising oncological safety or efficacy.

Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).