UK PureWick™ At-Home Pilot Study

Official title

An Open-label Pilot Study Conducted in the UK to Evaluate the Clinical Benefits of the PureWick™ Female External Catheter System Compared to Indwelling Urinary Catheters in Female Patients Receiving Home-based Care

Overview

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.

Detailed description

This is a combination of a retrospective / prospective, open-label, pilot study which aims to assess the clinical benefits of the PureWick™ Female External Catheter System compared to indwelling urinary catheters in female patients managed in a home care setting.

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.

The familiarization period will serve as a training phase, allowing both subjects and caregivers to receive instruction and adapt to the use of the study device.

Interventions

• Procedure 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.

Primary outcome measures

• 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 [Time frame: From enrollment to the end of treatment at 5 weeks]

Secondary outcome measures (1)

• To compare the possible pain intensity between subjects treated with the PureWick™ System and those with problematic indwelling urinary catheters [Time frame: From enrollment to the end of treatment at 5 weeks]

Eligibility criteria

Inclusion criteria

• Adult Female Subjects >18 years of age at the time of signing the informed consent.
• Treated with indwelling catheters for at least four weeks
• Encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation;
• Willing to comply with all study procedures in this protocol
• The subject (or subject's power of attorney) must be willing and able to read, understand, sign, and date the informed consent form.

Exclusion criteria

Subjects are excluded from the study if any of the following criteria apply:

• Has frequent episodes of bowel incontinence without a fecal management system in place; or
• Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
• Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes; or
• Is agitated, combative, and/or uncooperative and may remove the external catheter; or
• Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
• Has any pre-existing neurological, psychiatric, or other conditions that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
• Is known to be pregnant at time of enrollment (for women of childbearing age); or
• Has a confirmed diagnosis of urinary tract infection at the time of enrollment.
• Subjects with a urine output of ≥1800 mL over a 12-hour period who, or whose caregivers, are unable to independently empty the collection canister.
• Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 4 centers

• Rotherham Doncaster and South Humber NHS Foundation Trust — Doncaster
• South Leicestershire Medical Group — Leicester
• NCAS- Northamptonshire Continence Advisory Service — Northampton
• East of England Community Health and Care NHS Trust — Norwich

Identifiers

NCT: NCT07555548 · UCC-24HC014

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗