Recruiting

Automated Treatment

Sponsor:

SchwabCare

Code:

NCT03046810

Conditions

Incontinence, Urinary

Dermatitis

Incontinence, Fecal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wellness toileting system

Study Details

Brief summary:

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.

Conditions

Incontinence, Urinary

Dermatitis

Incontinence, Fecal

Study ID

NCT03046810

Start date

Apr 1, 2017

Status verified date

May, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to give informed consent.
  • Active functional urinary or fecal incontinence
  • Kennedy Scale Grade >2 with active incontinence associated dermatitis
  • Willingness to have device installed in home/care center

Exclusion Criteria:

  • Active perineal infection
  • Prior pelvic radiation
  • Perineal surgery within the prior 6 months
  • Known allergy or sensitivity to applied agents
  • Treatment for dermatitis within the prior 2 weeks.
  • Pre-existing pressure ulcer stage 2-4
  • Weight exceeding 300 pounds
  • Known allergy or hypersensitivity to cleanser or zinc oxide barrier spray
  • Home bathroom needs excessive upgrades, or needs ownership authorization

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Wellness toileting system

This group will use the wellness toileting system for their perineal hygiene and treatment of dermatitis

Interventions

Wellness toileting system

This group will use the wash, dry, cleanse, and apply zinc oxide barrier spray routinely for all toileting.

Primary outcome measure

  • Treatment of dermatitis [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Skyline Urology

Recruiting

Torrance, California, United States, 90505

More Information

Sponsor

SchwabCare

Last update posted

May 31, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SchwabCare on 2018-05-31.