Recruiting

Observational Study

Sponsor:

SchwabCare

Code:

NCT03051321

Conditions

Incontinence

Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Wellness toilet system

Study Details

Brief summary:

The inability to independently manage perineal hygiene after toileting is a common issue for those in assisted living and nursing home environments. It is associated with skin breakdown (dermatitis), increased nursing costs, and loss of patient self-esteem and independence. Water-based toileting has been evaluated as a possible adjunct to patient care, but its uptake has been limited by ineffective cleansing and drying.

40 subjects with limitations in independent capacity for perineal hygiene that require assistance with toileting will be recruited from a continued care retirement center. Subjects will be assessed for incontinence, and skin breakdown or irritation. Subjects will be provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to be applied in cases of dermatitis.

Investigators hypothesize that subjects given the device will remain more independent, with higher quality of life. Secondary hypotheses are that subjects will experience improved relationships with their caregivers, and that active dermatitis will be treated in those already with the condition, and prevented in those at risk.

Conditions

Incontinence

Dermatitis

Study ID

NCT03051321

Start date

Apr 1, 2017

Status verified date

May, 2018

Completion date

Oct, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

- Limitation of Activity of Daily Living - Toileting, requiring assistance, beginning stages of unmanaged incontinence. For the purposes of this study, toileting refers to maintenance of hygiene and ability to clean the perineum after urination or defecation. It does not include inability to transfer to a commode only.

Exclusion Criteria:

  • Inability to obtain consent
  • Weight over 300 pounds
  • Prior pelvic radiation
  • Pelvic Floor surgery within the 6 weeks prior to enrollment
  • Active perineal infection
  • Active chemotherapy

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Wellness toileting system

Subjects given SchwabCare Wellness Toileting system

Interventions

Wellness toilet system

Water-based toileting with capacity to apply zinc oxide barrier spray to treat incontinence associated dermatitis

Primary outcome measure

  • Days Remaining in independent living environment [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

The Canterbury

Recruiting

Rancho Palos Verdes, California, United States, 90275

The Village at Marymount

Recruiting

Garfield Heights, Ohio, United States, 44125

More Information

Sponsor

SchwabCare

Last update posted

May 30, 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 2018-05-30.