~4 spots leftby Apr 2026

Treatment of Incontinence Associated Dermatitis - Automated

(TRIAD-A Trial)

Recruiting in Palo Alto (17 mi)
RS
Overseen byRichard S Tilson, MD MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: SchwabCare
No Placebo Group

Trial Summary

What is the purpose of this trial?

Incontinence and the skin irritation (dermatitis) associated with it are common problems. Treatment of dermatitis is effective, but requires effective cleaning and application of a barrier substance to prevent further contact between urine or feces and the skin. Water based cleansing with the addition of a pH balanced cleanser is more effective than standard abrasive cleansing with paper or a cloth, and is better tolerated by those with skin irritation. Zinc oxide based barriers effectively promote healing and prevent further skin damage. Spray forms are less cumbersome and generally preferred, but are difficult to for the patient to apply independently given the challenge of accessing the perineum. 40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks 1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will be measured using a visual analog scale derived from the quality of life in incontinence scale. The investigators hypothesize that the device will 1) effectively treat incontinence associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.

Research Team

RS

Richard S Tilson, MD MPH

Principal Investigator

Director of Clinical Investigation

Eligibility Criteria

Inclusion Criteria

Ability to give informed consent.
Active functional urinary or fecal incontinence
Kennedy Scale Grade >2 with active incontinence associated dermatitis
See 1 more

Treatment Details

Interventions

  • Wellness Toileting System (Behavioural Intervention)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Wellness toileting systemExperimental Treatment1 Intervention
This group will use the wellness toileting system for their perineal hygiene and treatment of dermatitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

SchwabCare

Lead Sponsor

Trials
2
Recruited
80+