Benign Prostate Hypertrophy(BPH)

This study aims to evaluate the effect of operating room orientation video education delivered at different time points on postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. Patients undergoing transurethral resection of the prostate or holmium laser enucleation of the prostate will be randomly assigned to one of three groups: video education one day before surgery in the surgical ward, video education approximately 30 minutes before surgery in the operating room waiting unit, or routine preoperative information. Pain and state anxiety will be assessed at predefined preoperative and postoperative time points.

This study compares two FDA-approved surgical treatments for benign prostatic hyperplasia (BPH): Holmium Laser Enucleation of the Prostate (HoLEP) with MOSES 2.0 technology and Robotic Water Jet Ablation (RWJA) using the Hydros Robotic System. Men with BPH and prostate volumes between 50 and 180 mL will be randomly assigned to one of the two procedures. The study will measure changes in prostate volume, PSA, urinary flow, and bladder emptying at 12 months, along with safety, sexual function, continence, and healthcare utilization outcomes, which will be followed for up to 5 years after surgery.

This randomized, double-blind, placebo-controlled Phase 2 study is evaluating Teverelix DP in men following a first episode of acute urinary retention (AUR) associated with benign prostatic hyperplasia (BPH), a population at risk of recurrent urinary retention and subsequent surgical or minimally invasive intervention. The study is designed to evaluate the effects of Teverelix DP on total prostate volume and urinary function and to prospectively evaluate clinically meaningful outcomes including recurrent AUR, BPH-related surgical or minimally invasive intervention, protocol-defined treatment failure and clinical benefit. Participants will be randomized to one of four treatment groups evaluating two active Teverelix DP regimens: 90 mg administered intramuscularly (IM) and 120 mg administered subcutaneously (SC) and their respective matched placebo controls. The primary endpoint is percent change from baseline in total prostate volume (TPV) at Week 12. Participants will continue to be evaluated during the 28-week treatment period for urinary function and prospectively defined clinical outcomes, including recurrent AUR, BPH-related intervention, treatment failure and clinical benefit, and will be followed through Week 52 for protocol-defined longer-term assessments and safety follow-up. The study is designed to characterize biological activity, urinary function, clinical outcomes, safety and the relative treatment effects of the two Teverelix DP regimens to inform dose and route selection and subsequent clinical development.

Rezūm is a minimally invasive procedure that uses water vapor (steam) to treat urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia, BPH). It has been used in clinical practice since receiving FDA approval in 2015 and is recommended as a treatment option for men with moderate-to-severe urinary symptoms, including those who wish to preserve ejaculatory function. Clinical trials have shown that Rezūm improves urinary symptoms and flow rates, with benefits that last for at least five years, a low reoperation rate, and a low risk of sexual side effects. Despite this evidence, several important questions remain. It is not well understood which patients are more likely to experience temporary urinary retention after the procedure, need repeat treatment, or develop ejaculatory changes. Standardized criteria for defining overall treatment success are also lacking. The MISTER study is a multicenter registry designed to evaluate real-world outcomes of Rezūm therapy in patients treated in the Russian Federation. Using data from a large patient cohort, the study aims to identify factors associated with urinary retention after catheter removal, the need for repeat treatment or return to medication, and changes in ejaculatory function. The study will also develop and test combined criteria for defining treatment success.

The study aims to investigate, through the International Prostatic Symptoms Score (IPSS) questionnaire, the non-inferiority of the therapy with the alpha-blockers+Serenoa repens combination compared to the alpha-blockers+antimuscarinic combination on storage lower urinary tract syndrome (LUTS) in patients with moderate-severe symptomatic benign prostatic hyperplasia (BPH).

Objectives of the study The aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients Study center The study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications). Patients visits will be carried out in the BPH Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. Laboratory tests of all patients will be performed at the same microbiology laboratory. Study population A total of 100 patients (50 in Group A and 50 in Group B) with BPH diagnosis will participate in this study. Study design Double-blind placebo-controlled randomized clinical trial Zero hypothesis (H0) and alternative hypothesis (H1): (H0): Group A demonstrates similar efficacy compared to Group B for the treatment of BPH patients. (H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients. Study endpoints Primary endpoint: The difference between the Group A and Group B in the change of IPSS score from baseline to 12 weeks after treatment initiation. Secondary endpoints: * Adverse events rate in all patients during study period. * The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation. * The difference between the Group A and Group B in the change of the following parameters from baseline to 6 and 12 weeks after treatment initiation 1. Qmax value 2. Prostate volume 3. Post void residual 4. IIEF-ED score 5. Psa value 6. TNFa, IL 6 values Treatment Visits : Patients accordingly to which group they will be randomized will receive: * Active treatment (Ralivia) Group : 1 pill of Ralivia per os/day for a 3-month period * Placebo Group : 1 placebo pill per os/day for a 3-month period Adverse events will be reported. FU Visit 1: 6 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported. PSA TNFa, IL 1β, IL 6, IL 10 will be measured through blood test. FU Visit 2: 12 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported. DRE will be performed . PSA TNFa, IL 6 will be measured through blood test.

Acute urinary retention (AUR) is a sudden and painful condition. It occurs when a person is unable to urinate. In men, AUR is most often caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH), which blocks the urethra. The first steps in treatment are to insert a catheter to empty the bladder and to start medication that acts on the prostate (an alpha-blocker). After some time, the catheter is removed during a so-called "Trial Without Catheter" (TWOC) to see whether the patient can urinate normally again. At present, it is unclear how long a catheter should remain in place before this trial is performed. In Dutch hospitals, the duration varies widely: in some hospitals, the catheter is removed after only a few days, while in others it stays in place for two weeks or longer. A longer catheter duration can cause more discomfort and complications, such as urinary tract infections or blood in the urine. Therefore, it is important to determine whether a shorter catheterization period is equally effective and safe compared to a longer one. The RELIEF study investigates whether a short catheter duration of three days is as safe and effective as the current average of fourteen days. A total of 478 men with acute urinary retention will participate in this nationwide randomized controlled trial. All participants will receive a catheter and start (or continue) treatment with an alpha-blocker. They will then be randomly assigned to one of two groups: one group will have the catheter removed after three days, and the other group after fourteen days. The main question is whether a shorter catheter duration is as successful as a longer one. Success means that the patient can urinate normally after catheter removal, without needing to have the catheter replaced. The study will also compare the number of complications, patients' experiences with the catheter, their quality of life, and the overall healthcare costs. By conducting this study, doctors will gain better evidence on the optimal timing of catheter removal in men with AUR. The goal is to avoid unnecessarily long catheterization, reduce discomfort and complications, and improve the quality of care for men with AUR. The results of the RELIEF study may help improve the management of AUR, making care more consistent, efficient, and patient-friendly both in the Netherlands and abroad.

Prostatic Artery Embolization (PAE) is a recognized mini-invasive treatment of bothersome Lower Urinary Tract Symptoms (LUTS) related to Benign Prostatic Hyperplasia (BPH). Particle embolics are used almost exclusively for embolization, with wide variation in the type and size of particles showing similar performance and safety results. Even if its durability relies on multiple risk factors, LUTS recurrence-free survival probability decreases with years. It is demonstrated that recanalization of the native prostatic artery is found in 66% of patients experiencing LUTS recurrence. Artery recanalization after several months has been reported in embolization with microparticles. The investigators addressed this issue using the liquid embolic agent SQUIDPERI in a prospective cohort of patients undergoing rePAE and showed a good clinical success rate (76.7%) at 3 months. Since then, the investigators perform initial PAE using SQUIDPERI with good results. The aim of SQUID-PAE study is to assess the efficacy of PAE using SQUIDPERI in an initial PAE setting in a multicenter prospective study.

This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.

The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.

The investigators propose conducting a randomized controlled trial at the Men's Health Clinic to evaluate whether patients who start and continue mirabegron postoperatively after undergoing Rezum therapy experience enhanced patient-reported outcomes, improved quality of life (QoL), and comparable rates of adverse events. There are no predicted adverse events of this study. There are no identified potential harms of this study.

Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures. Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).