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IncontinenceNCT03051321

Maintaining Lower Levels of Care Through Automated Perineal Hygiene

A study testing Wellness toilet system in people with Incontinence and Dermatitis, run by SchwabCare at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Incontinence, Dermatitis
What is being tested?
Wellness toilet system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
1 Apr 2017to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Jacqueline Silvia contact

(855) 239-2106

jsilvia@schwabcare.com

Richard s Tilson, MD MPH contact

(978) 459-6737

mtilson2@lowellgi.com

United States2 sites, 2 recruiting
  • The Village at Marymount

    Garfield Heights, Ohio, 44125

    Jacqueline Silvia

    Recruiting
  • The Canterbury

    Rancho Palos Verdes, California, 90275

    Jacqualine Silvia

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

The prevalence of incontinence and inability to maintain personal perineal hygiene increases with higher levels of nursing care. While more than 75% of those in assisted living and home care settings are able to independently care for themselves after toileting, up to 75% of nursing home residents have regular episodes of urinary or fecal incontinence and require aid with toileting. This implies that whereas incontinence is a primary diagnosis in only 10% of nursing home admissions, it represents a major contributor to morbidity among all nursing home residents, and with that, an important target for efforts at cost containment. Inadequate independent perineal hygiene and dependence on caregivers for effective toileting raises global costs and adversely affects well-being for those in assisted living and dependent living environments. It is also associated with an increase in incontinence and incontinence associated dermatitis, which carries higher risks of urinary tract infection and skin infection. Finally, in many institutions, loss of toileting independence mandates a shift to a higher intensity environment, and with that incurs significant cost.

Water-based toileting has been evaluated as a potential intervention for nursing home residents with impaired toileting capacity. In that study, while investigators found significant overall improvement those using the device, less than half were neither effectively cleaned nor dry at the end of use. Because of this limited reliability, currently available devices are not thought to offer enough significant advantages for routine use in nursing home settings.

Incontinence and incontinence associated dermatitis (IAD) is common among residents with impaired perineal hygiene and toileting. Adherence to prescribed medications and therapies directed at the perineum is a major barrier to regular use among those with fecal or urinary incontinence. Difficulty in accessing the perineum make adherence challenging to those with both full and limited mobility, often requiring assistance from a caregiver. The associated loss of independence and dignity are major detriments to quality of life. Novel formulations of zinc oxide, using aerosol based spray application, facilitate use and improve patient acceptance. In a 2014 nursing home based industry study, spray based zinc oxide was preferred by 80% of patients and caregivers, and improved treatment and prevention of IAD in 70% of the study participants.

Adequate cleansing and drying prior to the application of barrier products is key to effective prevention of skin breakdown. Water-based cleaning of the perineum after toileting has been demonstrated to improve hygiene over standard mechanical, paper-based cleansing, especially in those with limited mobility or incontinence. Evidence further demonstrates that the addition of pH balanced cleansers, applied without mechanical abrasion from cloths or wipes, advances hygiene and minimizes risk of secondary infection.

Study Aims

The aims of this study are to evaluate whether an automated delivery system for cleansing the perineum can keep subjects who would normally move to higher levels of assistance at lower levels of nursing care. A secondary aim will be to evaluate whether an automated hands-free application of zinc oxide barrier spray effectively treats and prevents incontinence associated dermatitis in a population with active or recurrent IAD. Finally, the study aims to demonstrate cost savings through a cost effectiveness analysis.

Being tested
Wellness toilet system
Medical subject headings
Dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wellness toilet systemDevice

    Also called SchwabCare Wellness Toileting System

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

Study groups in NCT03051321
Study groupRoleWhat they receive
Wellness toileting systemExperimentalSubjects given SchwabCare Wellness Toileting system
Receives: Device: Wellness toilet system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days Remaining in independent living environment

    Subject does not require assistance for perineal hygiene that requires change of living environment

    Measured: 24 weeks

Secondary outcomes (2)
  1. Improved quality of life

    Subject using device will experience improved quality of life derived from the quality of life in incontinence scale

    Measured: 24 weeks

  2. Treatment and prevention of incontinence associated dermatitis

    Device will treat existing, and prevent dermatitis in subjects with incontinence, evaluated using the Kennedy Scale

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2017
  2. Study start1 Apr 2017
  3. Primary completionJun 2018 (estimated)
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03051321
Sponsor's protocol ID
SC-02
Status last verified
May 2018
First submitted
7 Feb 2017
Last updated
30 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Wellness toilet system in people with Incontinence and Dermatitis, run by SchwabCare at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacqueline Silvia ((855) 239-2106, jsilvia@schwabcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days Remaining in independent living environment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.

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