Clinical Research Directory

Ambulatory Long Length URodynamics Evaluation

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.

Preoperative Outreach to Improve Surgical Attendance

This study aims to evaluate the impact of reminder call intervention on no-shows for urologic procedures in patients identified to be high risk for no-showing. Patients scheduled to undergo a urologic procedure will be randomized into two groups: the intervention group, who receives a series of reminder calls and text messages about appointment details and patient questions prior to the procedure date; and the control group, who receives standard care only. Secondary outcomes include rates of patient re-scheduling and healthcare utilization.

Pelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Exercises in Pediatric Patients

Dysfunctional voiding (DY) is one of the most common conditions in children. Various treatments are available. Participants will be randomly assigned to either PFMT (Group I) or PFMT+DNS (Group II). PFMT is the gold standard and routinely administered in hospitals for children diagnosed with dysfunctional voiding who are referred by a urologist. The PFMT group serves as the control group, and treatment will be scheduled for a total of 10 weeks, three days a week. During PFMT, children receive instruction about the pelvic floor using video visuals and increase awareness of their pelvic floor muscles. They are then instructed on how to contract and relax their muscles to control urination. DNS training is an exercise model that begins with spinal stabilization and addresses muscle synergies. Patients included in the study will be evaluated twice, at the beginning and at the end of the treatment: Voiding Disorders Symptom Score (VODS), Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0), Pediatric Incontinence Questionnaire (PIN-Q), Bladder Bowel Dysfunction Scale (BDS), Bristol gaita scale, and Children's Body Image Scale.

Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.

80% of patients with newly diagnosed metastatic hormone sensitive prostate cancer have bone metastases. There are mutations that are described with early disease progression when on hormone therapy for prostate cancer. In the NHS setting it is difficult to detect and monitor the patients. There are biochemical changes in the body that are associated with bone metastasis which can be detected in bodily fluids such as urine. Metabolites are substances involved in metabolism (= the chemical processes in the body needed for life. They are usually small molecules. Metabolomics is a way of studying the 'metabolome' which is the entire complement of small molecules present within the body. The metabolites are very sensitve to environmental or other changes and these can be markers for change caused by prostate cancer metastasis. Therefore the urinary metabolome is is potentially a very good indicator of change caused by cancer and hormone treatment. Accurate and specific urine tests would be a way to allow better monitoring of patients. This study aims to investigate the changes of specific bone urinary metabolome markers (UMMs) and untargeted urine profiles to detect the response and progression of patients with prostate cancer (PC). We propose that UMMs are simpler, less difficult for patients and more sensitive and specific compared to conventional imaging and routine blood tests, the current gold standard.

A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth

This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.

RUTISS-Diary and RUTISS-65 Study

Existing patient-reported outcome measures assess acute urinary tract infection but do not support daily symptom tracking in recurrent UTI (rUTI) or meet the needs of older adults. This single-site study will develop and validate two adapted measures: the RUTISS-Diary for daily symptom monitoring and the RUTISS-65 for reporting symptoms in adults aged 65 years and over. Approximately 200 participants with rUTI will complete the RUTISS-Diary daily for 7 days and again on day 14. Participants aged 65 years and over will also complete the RUTISS-65 on days 1 and 2 to assess its reliability and validity.

Artificial Intelligence (AI)-Based Intraoperative Visualization is Increasingly Integrated Into Robotic Surgery Platforms; However, Its Impact on Surgeons' Cognitive Workload Remains Unclear. This Study Evaluated Perceived Workload Among Console Surgeons and Bedside Assistants According to Different

Robotic surgery is now widely adopted in urology, and the da Vinci Single-Port (SP) platform enables complex procedures through a single multichannel incision, with favorable perioperative and outpatient outcomes in selected patients. However, single-port access and AI implementation also introduce unique ergonomic and cognitive challenges for surgeons and operating room staff. Quantifying intraoperative workload has become crucial to understand how new technologies affect performance, safety and training. The National Aeronautics and Space Administration Task Load Index (NASA-TLX) is a validated multidimensional instrument for subjective workload assessment and has been increasingly applied to surgical and specifically urologic practice. In parallel, augmented reality and artificial intelligence (AI) are emerging as tools to enhance intraoperative visualization and anatomical understanding during robot-assisted urologic procedures. The da Vinci TilePro multi-image display already allows simultaneous viewing of auxiliary imaging, but evidence on how real-time AI overlays integrated via TilePro affect cognitive workload in single-port urologic surgery is lacking. This prospective pilot study evaluates the impact of different TilePro visualization strategies on surgeon and bedside assistant workload, measured by weighted NASA-TLX scores, and explores associations with operative metrics in elective SP urologic procedures.

The Glean Registry

A registry designed to collect real-world data (RWD) on the Glean Urodynamics System via a retrospective medical chart review.

Enhanced Vitals Monitoring After Major Surgery Trial

The aim of this clinical trial is to examine the feasibility of an enhanced vital sign monitoring solution in-hospital and at-home. This study includes adult patients undergoing inpatient major vascular or abdominal surgery. Researchers will compare the enhanced vitals monitoring group to the standard of care group to see if it may change post-operative management and outcomes. The primary question it aims to answer is if enhanced monitoring of surgical patient vitals can increase the number of days at home alive in the first 30 days after surgery. Participants in the intervention group will test two vitals monitoring devices, one in the hospital and one at home. They will also be asked to complete several questionnaires and a follow up phone call.

The Clinical Research of Traditional Chinese Medicine Compound Formulas

To observe the efficacy and safety of Shenkangling, a traditional Chinese medicine decoction, for renal ischemia-reperfusion injury, and to provide evidence-based medical evidence and ideas for clinical therapeutic use.

Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial

This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.