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Showing 1-20 of 94 trials
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.
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.
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.
NCT06136819
RT-310, a novel implant, is intended to minimally invasive treat locally the prostate gland for the management of prostate disease, while minimizing side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.
NCT07146386
This is a randomized, double-blind, controlled, non-inferiority multicenter Phase III clinical study to evaluate the efficacy and safety of H077 sustained-release tablets versus silodosin capsules in treating benign prostatic hyperplasia.
NCT06265519
Histologically, BPH is a benign proliferative process involving both epithelial and stromal elements and is characterised by progressive enlargement of the prostate. Symptom complex including increased frequency of urination, sudden feeling of urge to urinate, nocturia, difficulty in urinating, feeling of incomplete emptying of the bladder, decreased flow rate and intermittent urination are called lower urinary tract symptoms (LUTS). The most important cause of LUTS in men is BPH. Many structural and physiological changes occur in the lower urinary system with bladder outlet obstruction. Detrusor hypertrophy and bladder hyperactivity may occur due to bladder outlet obstruction. Although the density of afferent and efferent nerves in the bladder decreases after urethral obstruction, enlargement of their trunks indicates that changes occur in these nerves. In addition, changes also occur in the neural pathways of the central nervous system following lower urinary tract obstruction. Nerve growth factor (NGF) and brain derived neurotropin factor (BDNF) are trophic proteins that act as retrograde messengers between peripheral effector tissue and the nerves that innervate it. In peripheral tissues, the source of NGF and BDNF is presumed to be the target tissues innervated by nerves. Smooth muscle cells, fibroblasts, astrocytes and other cells synthesise NGF and BDNF in culture medium. Many potential stimuli that increase NGF in the lower urinary system have been identified. These are denervation, inflammation and mechanical tension. This information has led to the idea that autonomic innervation changes in the bladder may be related with changing NGF levels. Altered afferent and adrenergic innervation in the obstructed bladder increases the possibility that NGF plays an important role in this neural growth because this type of nerves are highly sensitive to this neurotrophin. In this study, we investigated NGF ve BDNF levels in urine samples obtained before surgery (Transurethral Prostate Resection, Prostate Enucleation with Holmium Laser and Prostate Enucleation with Thulium Fibre Laser) and after removal of obstruction in patients with bladder outlet obstruction secondary to benign prostatic enlargement using ELISA method, We aimed to determine the role of NGF and BDNF in bladder outlet obstruction and bladder changes secondary to obstruction by comparing with control patients without obstruction.
NCT04627701
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
NCT05027971
To obtain post-market safety and efficacy data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).
NCT06753071
The efficacy of pyridostigmine therapy after transurethral resection of prostate in cases with underactive urinary bladder
NCT06225479
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.
NCT06528613
Benign prostatic hyperplasia (BPH) is an age-related progressive condition of the prostate gland that results in an increase in prostate size. Although the "normal" prostate in adult men usually has a volume of 15-30 ml, a value above 30 ml is usually considered "enlarged". However, the threshold at which a prostate is considered enlarged has not been strictly defined and therefore for many physicians an enlarged prostate is a subjective finding on examination. BPH can only be defined histologically (increase in the number of epithelial cells and stromal cells), but in clinical practice it is characterized by lower urinary tract symptoms \[LUTS\]. The disease leads to increased pressure in the urethra, causing resistance to urine flow, known as Bladder Outlet Obstruction (BOO). This resistance can also lead to changes in bladder function caused by the obstruction, such as overactivity of the bladder detrusor muscle or, conversely, reduced detrusor contractility. BOO can present as LUTS, infections or retention, as well as other conditions. LUTS can be divided into storage (irritant), obstructive (urinary) and post-urinary symptoms and appear frequently causing intense discomfort, reducing the quality of life. LUTS are traditionally associated with bladder outlet resistance (BOO), most commonly when histologic BPH progresses through benign prostatic enlargement (BPE) to benign prostatic obstruction (BPO).The European Urological Association (EAU) reports that LUTS are a common problem in adult men with a significant impact on quality of life (QoL). Accordingly, he suggests the use of the a1-blocker/muscarinic receptor antagonist combination in men with moderate to severe storage symptoms, voiding symptoms and PVR \< 150 ml, in order to reduce the risk of acute urinary retention and relieve irritants. (storage) symptoms, leading to an improvement in the patient's quality of life. Given the small abundance of data for patients in Greece with BPH, this study will evaluate the fixed combination of solifenacin/tamsulosin in terms of disease control and improvement of the quality of life of patients with BPH. Before enrolling in the study and before signing the consent form, patients must have already received the drug with solifenacin/tamsulosin and then they are enrolled in the observational study where the physician applies his/her standard clinical practice.
NCT06051383
Aim of this study is to evaluate the effect of conducting self-management interventions on severity of lower urinary tract symptoms (LUTS) for patients with benign prostatic hyperplasia (BPH). Research hypothesis: To fulfill the aim of this study, the following research hypothesis was formulated: Patients with benign prostatic hyperplasia will suffer less lower urinary tract symptoms (LUTS) after conducting self-management intervention than before conducting.
NCT06794333
The primary aim of this clinical trial is to determine whether one of the two methods under investigation, TPLA or WVA, is superior in the treatment of BPH. Additionally, as a secondary objective, the study seeks to evaluate the potential superiority of one method over the other concerning the sexual parameters of treated participants, assessed using the International Index of Erectile Function 5 (IIEF5) and the Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EJ). The researchers will compare the two methods under investigation (TPLA and WVA) to assess the potential superiority of one over the other. Participants will: * be randomized 1:1 between the two techniques and will undergo treatment at time 0; * undergo follow-up including uroflowmetry and assessment of the International Prostate Symptoms Score (IPSS), IIEF5, and MSHQ-EJ questionnaires at 3, 6, and 12 months.
NCT03350529
This study assesses feasibility and safety, the primary outcomes, of MRI guided transurethral high intensity focused ultrasound (HIFU) ablation for prostate diseases (PD). We will enrol 10 patients to each group with criteria as follows: localised prostate cancer (PC); locally advanced PC; locally recurrent PC after external beam radiation therapy (EBRT); benign prostatic hyperplasia (BPH). Secondary outcomes are both oncologic and functional outcomes and imaging based follow up after HIFU therapy will be also assessed.