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CompletedNCT05316012Smart DiapersUpdated Jun 23, 2023

The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment

An interventional study of Smart diapers in Incontinence, sponsored by University Ghent. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by University Ghent · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Sex
All
01

Study summary

The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts when the diaper requires changing. Potential benefits of the smart diaper compared to incontinence management products without sensor technology include: workload reduction, increased comfort for residents and staff, more person-centred care, increased quality of care, less skin damage and economic (e.g. less costs due to less excessive diaper changes), and/or environmental (e.g. less waste) gains.

02

Conditions studied

  • Incontinence

Keywords

  • incontinence
  • sensor technology
03

In context

Lead sponsor

University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Resident of nursing home
  • Urinary incontinence or double incontinence (Katz score incontinence ≥ 3) by day and night. (Score assessed in one week interval before start study period 1 and 2 "D1")
  • Wearing adult diapers as incontinence material, size M.
  • Unable to change diaper independently when saturated or leaking (Katz score toileting ≥ 3). (Score assessed in one week interval before start study period 1 and 2 "D1")
  • Written informed consent from resident or resident's legal representative.
  • Dutch speaking

Exclusion criteria

Exclusion Criteria:

  • Residents who are receiving end-of-life care
  • Residents with a Mini-Mental State Examination (MMSE)-score of \< 24
  • Residents with a dominant belly sleeping position
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Residents

    5 residents - fase 1 Intervention device: smart diaper (diaper, sensor and strips, without alerting system). 15 residents -fase 2, of which 5 residents of study phase 1 Intervention device: smart diaper (diaper, sensor and strips, with alerting system)

    Device: Smart diapers

Interventions

  • DeviceSmart diapers

    Residents receive standard continence care while using the smart diaper (without the alerting system) - fase 1 Diapers are changed as usual, e.g., after morning care, visual soiling, unpleasant odor, saturation, leakage. Residents receive continence care while using the smart diaper with the alerting system - fase 2

06

What researchers measure

Primary outcomes

  1. Mean percentage saturation

    The difference between the percentage saturation determined by the smart diaper and the percentage saturation based on the data registered in the frequency volume urine charts (FVUCs) (during each study period\* for each diaper change)

    Time frame: 10 days

  2. The % of correct warnings

    = warning on saturation of the incontinence material) generated by the sensor. a. Each warning generated by the sensor will be assessed by the nurse (correct/incorrect warning)

    Time frame: 10 days

  3. Frequency of skin irritations

    3. The frequency of skin irritations related to incontinence (Incontinence-Associated Dermatitis or IAD) in the gluteal/sacral area (assessed daily during each study period\*).

    Time frame: 10 days

07

Study locations

1 site
  • WZC Heilig Hart vzw
    Oudenaarde, 9700, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05316012
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Apr 7, 2022
Start date
Jun 20, 2022
Primary completion
Oct 27, 2022
Completion
Nov 27, 2022
Last update
Jun 23, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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