UK PureWick™ At-Home Pilot Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence: After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWick™ Female External Catheter System.

Study summary

The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWick™ Collection System is different, it's placed outside the body .

In this study, researchers want to find out: how effective the PureWick™ Collection System is in helping women manage urine collection at home, whether patients prefer using PureWick™ Collection System over the usual catheter, how it affects their sleep, and overall well-being.The PureWick™ Collection System is intended for the treatment of patients who leak urine (called urine incontinence). The PureWick™ Collection System is designed to help manage urine in female patients without needing to insert a urinary catheter into the body.

Eligibility

Primary outcome measure(s)

• Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention versus the clinical impact with the use of the PureWick™ System requiring intervention, documented during a prospective 4-week study period — From enrollment to the end of treatment at 5 weeks
  Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention by the treating HCP, based on medical records from the 4-week period preceding subject enrollment versus the clinical impact with the use of the PureWick™ System requiring intervention by the treating HCP during the prospective 4-week study period. * Clinical impact for indwelling urinary catheters is defined as frequency and type of catheter-related problems such as infections, blockages, dislodgements, leakages, expulsion and bypassing, requiring intervention * Clinical impact with the use of the PureWick™ System is defined as frequency and types of PureWick™ System-related problems such as infections, leakages, dislodgements, and replacements, requiring intervention. * Subject-reported impact on daily activities measured by procedure and device related Adverse Events * Health Care interventions required due to catheter-related issues incl. nursing time versus

Trial sites (4)