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NCT07650968
This randomized controlled trial will compare three medication strategies before trial without catheter in men with acute urinary retention due to benign prostatic hyperplasia who were already taking tamsulosin 0.4 mg once daily before the retention episode. After urethral catheterization, eligible participants will be randomly assigned to one of three groups for 7 days: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily. The urethral catheter will be removed on Day 7, and the ability to void successfully without re-catheterization will be assessed. Follow-up will continue to Day 30, with additional recording of catheter-free status, recurrent urinary retention, urinary flow, post-void residual urine, symptom scores, adverse drug events, catheter-related complications, and the need for later benign prostatic hyperplasia-related surgery.
NCT07643220
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
NCT07643233
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
NCT07629479
This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Participants will be randomly assigned to either ejaculation-preserving B-TUEP or standard B-TUEP. The study will evaluate preservation of ejaculatory function, erectile function, urinary symptom improvement, uroflowmetry outcomes, post-void residual urine, perioperative complications, and need for retreatment during follow-up.
NCT05341661
A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure
NCT07585552
1. What is this study about, and why is it required? The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. The main question it aims to answer is: \- Is a particular type of anesthesia related to less or more bleeding during the surgery? 2. What will be assessed to answer the main question of this study? (Outcome measure(s)) 2.1. Primary outcome measure of this study is: \- Change in the hemoglobin level perioperatively. 2.2. Secondary outcome measures are: * Requirement for the usage of any vasoactive medication due to low blood pressure * Time passed until discharge. * Time passed until the removal of the bladder drainage catheter. * Ratio of the unwanted events that require additional intervention other than medication, fluids, or blood transfusions (Complications, Clavien-Dindo Grade III or higher). * International symptom questionnaire score 3 months after surgery. * Quality of life (QoL) score 3 months after surgery. * Peak urinary current velocity (Qmax) and post-void residual volume measurement 3 months after surgery. 3. Can anyone participate in this study? Voluntary participants should meet the following criteria: * Being older than 18 years old. * Having bothersome lower urinary tract symptoms due to prostatic enlargement requiring surgical treatment. * Having no untreated or uncontrolled systemic disease, which refers to having an ASA (American Society of Anesthesiologists Physical Status Classification System) score III at most.
NCT07578428
This study evaluates and compares two minimally invasive surgical therapies for treating men with benign prostatic hyperplasia (BPH) who specifically have an enlarged median lobe. The two treatments being compared are Rezūm (water vapor thermal therapy) and EchoLaser (transperineal laser ablation). Participants will be randomized into two equal groups to receive either the Rezūm treatment or the EchoLaser treatment. The primary goal of the study is to evaluate the change in urinary symptoms over a 6-month period using the International Prostate Symptom Score (IPSS). The study will also assess how well each treatment improves urine flow, reduces the size of the prostate, preserves sexual function, and minimizes complications.
NCT07526675
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.
NCT05574244
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.
NCT06668142
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
NCT07264205
RT-310, is intended to deliver drug locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.
NCT07468084
This prospective observational cohort study aims to evaluate postoperative cognitive outcomes in patients undergoing surgical treatment for benign prostatic hyperplasia (BPH). Two commonly used surgical techniques-Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP)-will be compared. Cognitive function will be assessed before surgery and three months after surgery using validated neurocognitive and psychological assessment tools. The primary outcome measure is the change in Montreal Cognitive Assessment (MoCA) score. Secondary outcomes include changes in Mini-Mental State Examination (MMSE), Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI) scores. The study aims to determine whether the type of surgical technique independently influences postoperative cognitive function after adjusting for important patient-related factors such as age and educational level.
NCT07466030
The aim of this study is to evaluate the impact of daily tadalafil 5 mg on storage lower urinary tract symptoms (LUTS) during the early postoperative period following Anatomical endoscopic enucleation of prostate in a randomized controlled clinical trial.
NCT05784558
The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.
NCT03297281
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.
NCT05274672
The purpose of this study is to investigate whether prescribing a 3-day course of antibiotics after Holmium laser enucleation of the prostate (HoLEP) reduces the risk of urinary tract infection. The findings of this trial will have a major impact on clinical practice to either justify the prescription of antibiotics after HoLEP or give urologists more confidence in not prescribing antibiotics prophylactically after HoLEP.
NCT07016620
Benign prostatic hyperplasia (BPH) is a common condition affecting aging men, often leading to lower urinary tract symptoms (LUTS). While Minimally Invasive Surgical Therapies (MIST) procedures offer less invasive alternatives to traditional surgery, some patients experience symptom recurrence or require further intervention due to lack of adequate relief of obstruction. Treatment of persistent obstruction after MIST therapy (BPH salvage therapy) typically requires surgical intervention like transurethral resection of prostate (TURP). This study proposes to evaluate the effectiveness of in-office transperineal laser ablation (TPLA) using the Echolaser system as a minimally invasive treatment option for these patients, potentially avoiding more invasive surgical procedures. The Cleveland Clinic sees a high volume of BPH salvage patients, making this an ideal setting for this research.
NCT06312722
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
NCT07306767
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.
NCT06817733
Objective of the Clinical Trial The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. The primary questions it aims to address are: Can precise prostate thermal vapor ablation under MRI/TURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)? What safety issues may arise in participants after undergoing prostate thermal vapor ablation? Study Procedures Participants Preoperative Evaluation: Participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests. Procedure: Participants will receive precise prostate thermal vapor ablation under MRI/TURS guidance. Postoperative Follow-up: Regular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire. Regular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR). Research Team The research team will conduct precise prostate thermal vapor ablation under MRI/TURS guidance for the participants and manage their follow-up assessments.