Clinical Research Directory

RT-310 Dose Escalation BPH Study

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.

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.

INTIBIA Pivotal Study

Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

HoLEP Sexual Survivorship

The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP). In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function.

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.

JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

To identify the effects of JING SI HERBAL TEA in the treatment of lower urinary tract symptoms after intravesical therapy in patients with bladder cancer.

Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate

The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.

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.

Effect of Music and Lighting on Anxiety During Urodynamic Study

This study is designed to evaluate the effects of environmental modifications, specifically music and lighting conditions, on anxiety in patients undergoing urodynamic study (UDS). Approximately 220 adult participants are planned to be randomly assigned to one of four intervention groups. Anxiety levels before and after the procedure will be assessed using the State-Trait Anxiety Inventory (STAI). The study aims to determine the independent and combined effects of music and lighting on patient anxiety during UDS.

Effects of Spinal Stabilization on the Pelvic Floor in Women With Multiple Sclerosis

The purpose of this study was to investigate the effects of spinal stabilization exercises focusing on the pelvic floor on core stability, urinary symptoms and pelvic floor muscle function in women with Multiple Sclerosis and lower urinary tract symptoms. Participants will be randomly assigned to a control group that receives pelvic floor muscle exercises only or an experimental group that receives both pelvic floor muscle exercises and spinal stabilization exercise focused on the pelvic floor. Outcome measures will be assessed pre- and post-intervention using validated instruments.

Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH

This is a prospective, two-stage, multi-center, pilot clinical study to evaluate the safety/tolerability/efficacy of the Omega System device. The Omega arc-shaped implant is inserted by the Omega delivery system into the prostate tissue of subjects to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). The study will first evaluate the Omega system on patients undergoing prostatectomy, which is not indicated for the device.

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

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.

BPH Global Registry

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.

Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation

This prospective randomized study will compare two surgical techniques for treating benign prostatic hyperplasia. Participants will be assigned to either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine and methylene blue or conventional bipolar prostatic enucleation-enucleoresection without injection. The injected mixture is intended to separate the enlarged prostatic tissue from the surgical capsule and reduce bleeding during surgery. The study will evaluate whether the hydrodissection-assisted technique improves operative conditions, surgical outcomes, postoperative recovery, urinary symptoms, and urinary flow compared with the conventional technique.

LURN: Urinary Urgency Phenotyping Protocol

The purpose of this study is to define and characterize important subtypes of patients with urinary urgency to improve our understanding of the pathophysiology, risk factors, experiences, and comorbidities to lay the foundation for more effective treatment by focusing on the most bothersome and difficult to treat symptoms of urinary urgency and urgency urinary incontinence.

Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH

This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.

Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors (5ARIs) in men with BPH and enlarged prostate volume. A total of 240 participants were randomly assigned to six treatment groups and followed for 12 weeks. Changes in urinary symptoms, erectile function, ejaculatory function, prostate volume, prostate-specific antigen (PSA), urinary flow rate, post-void residual volume, and adverse events were evaluated to determine the optimal combination regimen.

HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer

To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.

Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia

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.

Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD

Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency

Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia

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.

Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH

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.

Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

Double-J ureteral stents are commonly inserted after ureteroscopy, but they may cause bothersome urinary symptoms, pain, sleep disturbance, and reduced quality of life. This prospective randomized assessor-blinded three-arm clinical trial will compare oral solifenacin, oral melatonin, and their combination for improving ureteral stent-related symptoms in adult patients after unilateral ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. Participants will be randomized to receive solifenacin 5 mg once daily, melatonin 3 mg once nightly, or combined solifenacin 5 mg once daily plus melatonin 3 mg once nightly for 14 days after surgery. The primary outcome is the total Ureteral Stent Symptom Questionnaire score at postoperative Day 7. Secondary outcomes include total Ureteral Stent Symptom Questionnaire score at Day 14, change in questionnaire score between Day 7 and Day 14, Insomnia Severity Index score, Visual Analogue Scale pain score, adverse events, treatment compliance, and rescue analgesic consumption.

School-Based Bladder Health Intervention

The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children.