Benign Prostatic Hyperplasia

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

This prospective multicenter observational cohort study will evaluate clinical outcomes after selective median lobe transurethral surgery for benign prostatic obstruction. Eligible men with lower urinary tract symptoms or urinary retention who are scheduled for selective median lobe-only TURP, HoLEP, or anatomical endoscopic enucleation as part of routine clinical care will be enrolled and followed after surgery. The study will collect preoperative clinical data, symptom scores, uroflowmetry, postvoid residual volume, prostate volume, intravesical prostatic protrusion measurements, cystoscopic anatomical findings, intraoperative variables, and postoperative outcomes. The primary outcome is composite clinical failure at 12 months. The main aim is to identify practical preoperative urology-based anatomical and functional predictors of clinical failure after selective median lobe surgery and to develop an exploratory prediction model that may help improve patient selection in future practice.

Benign prostatic hyperplasia (BPH) is a common condition in older men and may cause bothersome lower urinary tract symptoms that can negatively affect quality of life. Surgical treatment with Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) is often recommended when medical therapy is insufficient. This prospective observational study aims to evaluate whether preoperative anxiety, depression, and surgical fear influence postoperative functional outcomes, urinary continence, erectile function, and patient satisfaction in patients undergoing HoLEP or TURP for BPH. Participants will complete validated psychological and functional questionnaires before surgery and during postoperative follow-up visits at 1 and 3 months. The study will also assess changes in psychological status after surgery and compare outcomes between HoLEP and TURP patients. The findings may help improve preoperative patient counseling and identify patients who could benefit from additional psychological support before surgery.

This study will evaluate the safety and effectiveness of thulium laser enucleation of the prostate combined with bladder neck incision in men with small-volume benign prostatic hyperplasia (BPH). Small-volume BPH may still cause significant bladder outlet obstruction and bothersome lower urinary tract symptoms, and the optimal surgical treatment for these patients remains uncertain. In this multicenter, randomized, single-blind, controlled trial, 426 eligible men aged 40 to 80 years will be assigned in a 1:1:1 ratio to one of three groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation alone, or transurethral resection of the prostate. The main goal is to compare the incidence of bladder neck contracture at 6 months after surgery. Other outcomes include symptom improvement, urinary flow, pain score, sexual function, and safety outcomes during follow-up.

Open simple prostatectomy is still performed for selected patients with benign prostatic hyperplasia, particularly in cases with large prostate volume. Postoperative bleeding, hematuria, clot retention, and transfusion requirement are clinically important complications after this procedure. This prospective randomized controlled trial will compare the effects of spinal anesthesia and general anesthesia on postoperative bleeding in patients undergoing open simple prostatectomy. Participants will be randomized into two groups: spinal anesthesia or general anesthesia. Tranexamic acid or any additional hemostatic agent will not be used. Postoperative bleeding will be assessed using hemoglobin and hematocrit changes, transfusion requirement, hematuria, clot retention, need for bladder irrigation, and bleeding-related reintervention. The study aims to determine whether spinal anesthesia is associated with reduced postoperative bleeding compared with general anesthesia in open simple prostatectomy.

Acute urinary retention is a common emergency in men with benign prostatic hyperplasia. After bladder drainage with a urethral catheter, patients usually undergo a trial without catheter to determine whether they can pass urine again without recatheterization. This study will evaluate whether adding tadalafil 5 mg once daily to tamsulosin 0.4 mg once daily improves the chance of successful trial without catheter in men with first-episode acute urinary retention due to presumed benign prostatic hyperplasia. Participants will be randomly assigned to receive either tamsulosin plus tadalafil or tamsulosin plus a matching placebo. Study medication will start within 24 hours after catheterization. The catheter will be removed on Day 7. If the first trial without catheter fails, the catheter will be reinserted and a second rescue trial without catheter will be performed on Day 14. The main outcome is overall catheter-free success by Day 14. Participants will also be followed for recurrent urinary retention, post-void residual urine, urinary flow, catheter-related complications, drug-related adverse events, and the need for benign prostatic hyperplasia-related surgery within 3 months.

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.

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

This prospective comparative study will evaluate Water Vapor Thermal Therapy (WVTT/Rezum) versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate (ES-B-TUEP) in sexually active men with symptomatic benign prostatic hyperplasia. Eligible patients will have moderate-to-severe lower urinary tract symptoms, preserved antegrade ejaculation at baseline, and will be candidates for procedural treatment after failure, intolerance, or unwillingness to continue medical therapy. This is not a randomized study. Treatment selection will be based on shared decision-making between the patient and the treating surgeon after standardized counseling about both procedures. The study will compare ejaculatory function, urinary symptom improvement, urinary flow, post-void residual urine, erectile function, perioperative outcomes, complications, catheterization duration, hospital stay, medication restart, and retreatment or reintervention during follow-up. The primary outcome will be the change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form Function domain score from baseline to 12 months.

This prospective comparative study will evaluate Water Vapor Thermal Therapy (Rezum) versus ejaculation-preserving Holmium Laser Enucleation of the Prostate (EP-HoLEP) in sexually active men with symptomatic benign prostatic hyperplasia and prostate volume 30-80 mL. Eligible patients will not be randomized. The treatment option will be selected through shared decision-making between the patient and treating physician after standardized counseling about the expected benefits, risks, recovery, catheter duration, urinary outcomes, durability, and potential effects on ejaculation and sexual function. The main objective is to compare the change in ejaculatory function from baseline to 12 months using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Function domain. Secondary outcomes will include urinary symptom improvement, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, antegrade ejaculation preservation, catheterization duration, hospital stay, complications, restart of benign prostatic hyperplasia medication, and retreatment or reintervention within 12 months.

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.

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.

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.

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.

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.

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).

Benign prostatic hyperplasia (BPH) is a debilitating condition which is highly prevalent in older males, up to 45% of those over the age of 45 are affected and 80% of those over the age of 70 are affected. While not all men with BPH experience problematic symptoms, many will experience lower urinary tract symptoms (LUTS) including difficulty passing urine, recurrent urinary tract infections, bladder stones, and hematuria. Holmium Laser Enucleation of the Prostate (HoLEP) is the gold standard in terms of surgical BPH management and is associated with a low risk for requiring repeat interventions. However, in the weeks following HoLEP procedures many men will experience transient urinary incontinence which can be distressing to patients. In the setting of prostate cancer, exercise and mental health supports prior to surgery has been shown to improve incontinence and post-surgical recovery. This is often termed prehabilitation and consists of programming done in the months before surgery. The objective of this study is to assess the safety and feasibility of prehabilitation programming prior to HoLEP procedures for men with BPH. The investigators will be randomizing 40 patients into 2 groups, one receiving standard of care interventions prior to their HoLEP surgery and one receiving at least 12 weeks of comprehensive prehabilitation programming including: pelvic floor physiotherapy, access to additional informational resources, and access to mental health supports including individual and couples counselling. In both groups the investigators will be collecting key demographics and clinical information from patients as well as assessing their urinary function through several questionnaires before prehabilitation, immediately before surgery, and up to 1 year after surgery. The investigators hope to establish that prehabilitation is a safe and feasible option for these patients. Secondarily investigators hope to provide evidence that prehabilitation improves incontinence faster following HoLEP procedures and improves post-surgical recovery.

Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.

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.

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.

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

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.

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

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

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.