Urodynamics

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.

Study Topic This research aims to evaluate the effects of virtual reality (VR) application during noninvasive urodynamics on patients' vital signs, anxiety, and satisfaction levels. Significance of the Problem Urodynamic studies are essential diagnostic methods for assessing lower urinary tract functions. However, they often cause discomfort, pain, and high levels of anxiety in patients. This not only negatively affects the patient experience but also creates uncertainty in clinical decision-making. Previous studies have shown that nursing interventions such as music therapy, aromatherapy, and heating pads effectively reduce anxiety. Recently, VR technology has emerged as a promising tool to distract patients, thereby reducing pain and anxiety. Aim of the Study To investigate the effects of VR application during noninvasive urodynamics on: Vital signs, Anxiety, Comfort, and Patient satisfaction. Methodology Design: Single-center, randomized controlled clinical trial. Setting/Duration: Urology Outpatient Clinic, Ankara Etlik City Hospital, September - December 2025. Sample: Based on power analysis, at least 26 patients per group; total minimum of 52 participants. Inclusion criteria: 18-50 years old, undergoing noninvasive urodynamics for the first time, voluntary participation. Exclusion criteria: Previous urodynamics, use of anxiolytics/antidepressants, communication/vision/balance impairments. Randomization: Block randomization (block size 6). Data Collection Tools Descriptive Characteristics Form State-Trait Anxiety Inventory (STAI) Vital Signs and Urodynamic Parameters Monitoring Form Patient Satisfaction and Comfort Assessment (Visual Analog Scale - VAS) VR Application Satisfaction Form Interventions VR Group: During uroflowmetry, patients will experience a 360° virtual hygienic and spacious bathroom environment via VR goggles. Control Group: Routine clinical practice only, with standard pre-procedure information. Data Analysis Data will be analyzed using SPSS 21.0. Normality will be tested with Kolmogorov-Smirnov. Between-group differences will be assessed using Independent Samples t-test or Mann-Whitney U test, as appropriate. Statistical significance will be set at p \< 0.05. Ethical Considerations Ethical approval and hospital permission were obtained. Informed consent will be collected from all participants prior to data collection.

To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.

To demonstrate the feasibility of a pressure-flow study using a urinary condom with drainage tube in the sitting and lying position in everyday clinical practice and the comparability of the measured values with the "conventional" pressure-flow studies according to the ICS standard with regard to the diagnosis of outlet obstruction in men.