A Pilot Study to Evaluate PureWick for Nocturia
Not Applicable
Suspended
- Conditions
- Nocturia
- Registration Number
- NCT05090722
- Lead Sponsor
- Northwell Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Women aged 50 years or older.<br><br> - Experiences 2 or more voids per night as assessed on a 3-day bladder diary.<br><br>Exclusion Criteria:<br><br> - Compromised skin integrity in the perineal area (e.g., ulcers, open wounds, etc.).<br><br> - Neurological impairment or psychiatric disorder preventing proper understanding of<br> consent.<br><br> - Unable to operate the PureWick system.<br><br> - Unable to complete required questionnaires and diaries.<br><br> - Investigator deems subject as unsuitable for enrollment.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night;Change in average number of nocturnal voids at baseline and at 3 months;Change of scores on the N-QoL at baseline and at 3-months
- Secondary Outcome Measures
Name Time Method Change in the incidence of urinary tract infection (UTI) at baseline and 3 months;Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months