Clinical Trials Logo

Clinical Trial Summary

In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.


Clinical Trial Description

In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. Approximately 30 female participants from 2 sites will be enrolled into the study. Those meeting eligibility criteria will be treated according to the treatment sequence assigned during randomization. Participants will view the standardized training video for the applicable product at the beginning of each treatment phase and have access to the Information for Use document (IFU) to review during each treatment phase. The total expected duration of subject participation is approximately 10 weeks. Participants will use the device assigned in treatment phase 1 overnight while sleeping for 4 weeks (28 days) before transitioning to the second assigned device in treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 weeks) between treatment phases and a re-screening of eligibility criteria before the second phase. In both treatment phases, participants will independently place and remove the FEC (female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is completed on the first day of the treatment phase. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate. Health Care Providers (HCPs) will visit participants' homes daily to perform a skin assessment and collect urine measurements during the treatment phases. Participants will be withdrawn from the treatment phase if grade 4 is achieved in any category on the Draize skin irritation scale. The secondary objectives are to assess quality of life, tolerability, comfort and ease of use. Quality of life and comfort and ease of use will be measured using self-reported changes in quality of life via the validated Nocturia Quality of Life (N-Qol) tool and subjective evaluation of the therapy via participant survey, respectively. Tolerability will be measured by number of days of actual use of both devices, and discontinuation rate attributed to the device's discomfort or inconvenience. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05710718
Study type Interventional
Source C. R. Bard
Contact
Status Enrolling by invitation
Phase N/A
Start date October 31, 2023
Completion date May 9, 2024

See also
  Status Clinical Trial Phase
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT04191863 - Sleep Architecture in Valproate-induced Nocturnal Enuresis in Primary School and Preschool Children.
Recruiting NCT03199508 - Clinical Values of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children N/A
Recruiting NCT06135311 - Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children N/A
Completed NCT03047720 - Scheduled Awakenings for the Treatment of Nocturnal Enuresis N/A
Recruiting NCT05617664 - Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis N/A
Completed NCT02328092 - A Double-blind Randomized Clinical Trial on the Efficacy of Magnetic Sacral Roots Stimulation for the Treatment of NE N/A
Completed NCT02068560 - The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion N/A
Withdrawn NCT02337413 - Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis Phase 4
Completed NCT01368913 - MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis N/A
Terminated NCT04420585 - Desmopressin for Bedwetting in Children With SCD Phase 4
Completed NCT02538302 - Minirin Versus Oxybutynin for Nocturnal Enuresis in Children Phase 3
Recruiting NCT04676139 - The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children Phase 3
Completed NCT03812094 - Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis N/A
Recruiting NCT03477812 - Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study
Completed NCT02178826 - Nocturnal Enuresis and Rapid Maxillary Expansion N/A
Recruiting NCT01575678 - The Effect of Melatonin on Nocturnal Enuresis Phase 2
Completed NCT01078753 - Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis Phase 3
Recruiting NCT04313192 - TENS Treatment for Bedwetting N/A
Completed NCT05178641 - Overnight Pant Study for Children With Nocturnal Enuresis N/A