Clinical Trial Search

Primary: Mean Residual Urine Volume — 12.4; 9.4 mL

Primary: Bladder Scan Measurements of Residual Urine Volume — 32.74; 34.78 Residual volume in mL — p=0.8762

Primary: Residual Urine Measured by Ultra Sound — 11; 6 ml — p=0.56

Primary: Rate of Catheter-associated Urinary Tract Infection — 10; 12 infections per 1000 days

Primary: Percentage of Participants — 91.5 percentage of participants

Primary: Discomfort During Catheter Insertion on a Visual Analogue Scale — 1.2; 1.0; 1.1 score on a scale

Primary: Total Catheter Related Pain — 1.25; 2.3 units on a scale

Primary: Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr — 4; 5 Participants

Primary: State-Trait Anxiety Inventory-State Scores — 37.9; 40.7; NA; 37.7 units on a scale

Primary: Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) — 7; 6 Participants

Primary: Discomfort Measured on the Visual Analog Scale (VAS) — 3.7; 2.6 cm — p=0.0018

Primary: The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as…

Primary: Number of Participants With Post Operative Urinary Retention — 23; 21 Participants

Primary: Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) — 23.22; 15.87 milliliters

Primary: Urinary Tract Infection Rate — 24; 29 Participants — p=0.30

Primary: Discomfort — 2.25; 2.52 units on a scale

Primary: Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. — 3; 10; 5; 6 participants — p=0.0650

Primary: System Usability Scale — 4; 7 score on a Likert scale

Primary: Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) — 15.3; 23.7 mL

Primary: Residual Urine at 1st Flow-stop — 35.0; 1.1; 0.2; 37.0 mL — p=0.010

Primary: Residual Urine at 1st Flow-stop During Nurse Catheterization — 59.4; 13.1; 0.4 mL — p=0.074

Primary: Urine Output of SOC Device Versus Accuryn — 0; 5 Patients with airlocks

Primary: Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. — 0.84; 0.76 score on a scale

Primary: Rate of UTI While Colonized With E. Coli 83972. — 8.5 UTIs per 1000 patient-days

Primary: Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days — 79 Participants

Primary: Number of Participants With Acute Urinary Retention — 6; 7 Participants

Primary: Residual Urine at 1st Flow-stop During Nurse Catheterization — 28.6; 0.0; 0.0 mL — p=0.001

Primary: Number of Participants With Postoperative Urinary Retention — 11; 11 Participants — p=0.5

Primary: Total Bacteria Count Change From Baseline and After 24 Hours. — -62519; 57448 CFU/mL — p=0.6250

Primary: Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score…