Clinical Research Directory

Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora

The primary objective of this clinical trial is to evaluate the safety of autologous engineered corpora cavernosa + albuginea constructs for treatment of complex penile deformities. Autologous endothelial and smooth muscle cells obtained from enrolled subjects' corpora cavernosa biopsy sample, will be culture expanded in vitro and used to seed decellularized corpora cavernosa + albuginea obtained from cadaveric-donors to create autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile tissues.

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).

Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)

This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). The investigators attempt to perform HoLEP as a same-day discharge (SDD) procedure, but at Northwestern Memorial, the SDD rate is currently approximately 60%. The limiting factor in SDD is hematuria. Tranexamic acid (TXA) is a clot promoting drug that is commonly used by orthopedic, cardiac and obstetric surgeons to prevent bleeding. The primary outcome will be to assess if there is a difference in SDD rates in those who receive TXA vs. those who do not. Secondary outcomes will assess bleeding complications (defined as unplanned ED visit/clinic visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion) between participants who receive TXA vs. those do not. The study will also assess differences in perioperative complications associated with TXA including but not limited to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between the groups. The study will also assess for the duration of postoperative hematuria between groups as well as differences in operative times between the groups. The investigators anticipate that there may be up to a 25% increase in SDD rates in those who receive TXA vs. those who do not.

Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals

This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group. The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.

Long Term Extension Study in Patients With Primary Hyperoxaluria

The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (\<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.

Trial for Reliability of Urodynamics SysTem

The goal of this prospective trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms. The main question\[s\] it aims to answer are: • What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics? Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS. Researchers will compare GUS data with that from a conventional urodynamics exam.

HPI Effect in Robotic Urological Surgery on AKI

It is a single-center randomized controlled trial that aims to figure out the effect of the hypotension prediction index (HPI) on the prevention of acute kidney injury (AKI) after robot-assisted urological surgery. The primary hypothesis is that HPI software guidance prevents postoperative AKI by reducing the duration and severity of intraoperative hypotension (IOH).

Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.

This study is being done to compare usefulness of data collected in uroflowmetry, a test that measures the amount of urine released from the body, at home versus in the doctor's office. Additionally, investigators are assessing patient satisfaction when completing a virtual visit for lower urinary tract symptoms (LUTS), related to prostatic enlargement, compared to an in person visit. The three devices being investigated have not been used in the home setting to make urinary measurements as is typically done in clinic. The goal is to test the effectiveness and accuracy of these devices compared to our standard clinical practices and demonstrate their ability to provide useful information in the home setting.

Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures

The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate.

Aquablation in Benign Prostatic Hyperplasia in Canada

To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.

Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.

Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery

The aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on POD in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of POD and improving the prognosis and quality of life.

PACT Programme for Parents of Children With SHCN

This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.

Developing a PROM for Recurrent Urinary Tract Infection

This study aims to develop and validate the first set of patient-reported outcome measures for recurrent urinary tract infection (UTI): the Recurrent UTI Symptom Scale and the Recurrent UTI Impact Questionnaire. These tools could be used in clinical practice, clinical trials and research to gather an insight into a patient's perspective of their recurrent UTI symptom severity and its impact on their life, as well as determining any possible improvement or other change in their condition due to interventions (e.g. antibiotic treatment).

Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures

This is a Phase I clinical study to determine the safety and efficacy of using autologous, engineered urethral constructs for the treatment of urethral strictures in adult males. The proposed study design is a prospective non-randomized and uncontrolled single-center investigation. Autologous urothelial cells (UCs) and smooth muscle cells (SMCs), obtained from enrolled male subjects' bladder tissue samples, will be culture expanded in vitro and used to seed tubular PGA scaffolds to create autologous urethral constructs for the repair of urethral strictures.

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

Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients

This is a single-arm, pretest-posttest study evaluating the effects of a 21-day comprehensive spa care (Komplexní lázeňská léčebně rehabilitační péče, KLP) on patients with nephrological and urological conditions treated at a spa facility in Mariánské Lázně, Czech Republic. The study enrolls 150 adult patients (75 men and 75 women), aged 40-70 years, who are prescribed KLP for indications VIII/1 (recurrent and chronic non-tuberculous inflammation of the kidneys and urinary tract), VIII/2 (nephrolithiasis without urinary tract obstruction, nephrocalcinosis), VIII/3 (conditions after kidney and urinary tract surgery), and VIII/4 (chronic prostatitis or prostatovesiculitis resistant to pharmacological treatment). The spa treatment consists of the use of natural healing resources of Mariánské Lázně, including a mineral spring drinking cure, balneotherapy (mineral water baths), peloid therapy, carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy. The standard treatment duration is 21 days, during which each patient receives a total of 63 therapeutic procedures and drinks mineral spring water three times daily. Patients undergo assessments at the beginning (days 1-3) and at the end (days 19-21) of their treatment. Assessments include physical examination, abdominal and urinary tract ultrasound, blood and urine sampling with laboratory analysis, body composition measurement using bioelectrical impedance analysis (InBody), and psychometric questionnaire surveys. The primary aim of the study is to objectively assess the therapeutic effect of comprehensive spa care on nephrological and urological diseases by comparing pre-treatment and post-treatment clinical, laboratory, and patient-reported outcomes. The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen (decision of November 2, 2023, ref. no. 437/23).

Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children

The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.

The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents - the PpUF-study.

The aim of this study is to investigate whether the voided urinary, perineal/preputial, and the fecal microbiota are different between children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the study aims to investigate if the microbiota is different according to the severity of DUI and if the microbiota is changed throughout treatment of DUI. A follow-up study will as well be performed on healthy children to investigate how the microbiota evolves with increasing age and pubertal stage. Children with OAB and DUI will be recruited from involved pediatric departments, and specimen in the form of urine, perineal/preputial swabs, and feces will be collected according to the protocol.

Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal

In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction. It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial.

A Study of Ward Admissions for Haematuria

This multicenter, prospective observational study will evaluate national and international practice variations (if present) in the emergency management of patients admitted to hospital with haematuria, inform a consensus guideline for best practice and provide evidence to design an implementation study to optimise haematuria management pathway.

Evaluation of AI Large Models for Diagnosis and Treatment in Real-World Cases: Multicenter Retrospective Study

This multicenter retrospective study aims to evaluate the diagnostic and therapeutic performance of three large language models-ChatGPT, Gemini and Deepseek-using 800 archived inpatient medical records from urology departments across four tertiary hospitals. The study will focus on the accuracy and applicability of these models in disease recognition, preliminary diagnosis and treatment recommendation generation, in order to explore their potential value and limitations in supporting clinical decision-making in real-world settings.

Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes

Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.