Incontinence, UrinaryTRIAD-ANCT03046810
Treatment of Incontinence Associated Dermatitis - Automated
A study testing Wellness toileting system in people with Incontinence, Urinary and Dermatitis, run by SchwabCare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence, Urinary, Dermatitis, Incontinence, Fecal
- What is being tested?
- Wellness toileting system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to Sep 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Weight exceeding 300 pounds
- Known allergy or hypersensitivity to cleanser or zinc oxide barrier spray
- Home bathroom needs excessive upgrades, or needs ownership authorization
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Skyline Urology
Torrance, California, 90505
Jacqueline Silvia
About this study
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.
Read the detailed description
Incontinence and incontinence associated dermatitis (IAD) are common problems. A recent CDC study noted that up to 50% of noninstitutionalized patients aged 65 and older experienced episodes of incontinence at least monthly, and that 40% of those with incontinence develop secondary IAD The treatment of IAD is focused on effective cleaning and prevention of further exposure to irritant liquids and solids through barrier creams. Enzymatic washes have proven efficacy over soap and water, and zinc oxide is the standard of care for barrier function. Combined, effective cleansing and barrier use treats IAD in as little as 6 days, and effectively prevents recurrent skin damage. In one study, an effective preventive regimen of regularly applied skin therapy reduced the incidence of IAD in an at risk population from 25% to 5%. The combination of enzymatic skin cleanser and barrier protection is the standard of care for maintenance of skin integrity in patients with chronic urinary and fecal incontinence.
Adherence to prescribed regimens is a major barrier to regular use of substances applied to the perineum. 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 the efficacy of an automated delivery system for cleansing the perineum, and applying zinc oxide barrier spray to effectively treat and prevent incontinence associated dermatitis in a population with active or recurrent IAD. Secondary aims will be to assess preference for the automated delivery system over standard wash and manually applied barrier sprays.
- Conditions
- Incontinence, Urinary, Dermatitis, Incontinence, Fecal
- Being tested
- Wellness toileting system
- Medical subject headings
- Urinary Incontinence, Dermatitis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness toileting systemDevice
Also called SchwabCare Wellness Toileting System
This group will use the wash, dry, cleanse, and apply zinc oxide barrier spray routinely for all toileting.
| Study group | Role | What they receive |
|---|---|---|
| Wellness toileting system | Experimental | This group will use the wellness toileting system for their perineal hygiene and treatment of dermatitis Receives: Device: Wellness toileting system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of dermatitis
Improvement in the Kennedy Score for Dermatitis
Measured: 6 weeks
Secondary outcomes (2)
Prevention of recurrent dermatitis
prevention of recurrent dermatitis by clinical criteria
Measured: 12 weeks
Improvement in quality of life
Assessed by visual analog scale derived from quality of life in incontinence scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Apr 2017
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- SchwabCare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard S Tilson, MD MPH, Principal investigator, Director of Clinical Investigation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046810
- Sponsor's protocol ID
- SC-01
- Acronym
- TRIAD-A
- Status last verified
- May 2018
- First submitted
- 6 Feb 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data at this time
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Incontinence Associated Dermatitis - Automated
- ClinicalTrials.gov ID
- NCT03046810
- Acronym / sponsor ID
- TRIAD-A / SC-01
- Conditions
- Incontinence, Urinary, Dermatitis, Incontinence, Fecal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SchwabCareUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Incontinence and incontinence associated dermatitis (IAD) are common problems. A recent CDC study noted that up to 50% of noninstitutionalized patients aged 65 and older experienced episodes of incontinence at least monthly, and that 40% of those with incontinence develop secondary IAD The treatment of IAD is focused on effective cleaning and prevention of further exposure to irritant liquids and solids through barrier creams. Enzymatic washes have proven efficacy over soap and water, and zinc oxide is the standard of care for barrier function. Combined, effective cleansing and barrier use treats IAD in as little as 6 days, and effectively prevents recurrent skin damage. In one study, an effective preventive regimen of regularly applied skin therapy reduced the incidence of IAD in an at risk population from 25% to 5%. The combination of enzymatic skin cleanser and barrier protection is the standard of care for maintenance of skin integrity in patients with chronic urinary and fecal incontinence.
Adherence to prescribed regimens is a major barrier to regular use of substances applied to the perineum. 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 the efficacy of an automated delivery system for cleansing the perineum, and applying zinc oxide barrier spray to effectively treat and prevent incontinence associated dermatitis in a population with active or recurrent IAD. Secondary aims will be to assess preference for the automated delivery system over standard wash and manually applied barrier sprays.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellness toileting system | Experimental | Device: Wellness toileting systemThis group will use the wellness toileting system for their perineal hygiene and treatment of dermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness toileting systemAlso: SchwabCare Wellness Toileting SystemThis group will use the wash, dry, cleanse, and apply zinc oxide barrier spray routinely for all toileting. | Device | Wellness toileting system |
Primary outcome
Treatment of dermatitis
Time frame: 6 weeks
Improvement in the Kennedy Score for Dermatitis
2 secondary outcomes
Prevention of recurrent dermatitis
Time frame: 12 weeks
Improvement in quality of life
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: No. No plan to share individual participant data at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard S Tilson, MD MPH principal investigator
Director of Clinical Investigation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness toileting system in people with Incontinence, Urinary and Dermatitis, run by SchwabCare at 1 site 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 4 inclusion and 9 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 31 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 1 site 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 (+1 (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?
Treatment of dermatitis (time frame: 6 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 31 May 2018.