A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product

NCT06091111 | Completed

• 1 other identifier: HEAT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs) compared to reference AHPs currently being used by the subjects. The study is cross-over and subjects will act as their own control, using their regular device during a 10-day period and comparing this to use of investigational device for 10 days with an initial 3-5 day transition period. In total the subjects participate in the study for about 30 days. The sequence of device use is randomized. The target population are subjects who are suffering from urinary incontinence and are current users of AHPs to manage the incontinence. Subjects are care dependent and being cared for in a care home. The study is conducted at multiple care homes in the United Kingdom. The investigational device is a new type of AHP developed to be more sustainable with a disposable insert placed into a reusable pant. The leakage performance will be tracked by collecting used AHPs and assess the occurrence of leakages and urine content. The number of leakages during the intervention period will be compared to that of the reference period. As secondary outcomes safety, changes in skin condition and caregiver and subject product satisfaction is assessed. In total 42 subjects are planned for the study.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in absorbing product leakage rate

  For each resident a success rate (SR, number of products that do not have a urine leakage outside of the product) is calculated and compared between the baseline (standard of care) and the intervention (study device).

  20 days

Secondary Outcomes (3)

• Safety data

  20 days

• Skin health assessment scoring.

  20 days

• Caregiver and resident scoring perception of the investigational product compared to the reference product.

  20 days

Study Arms (1)

Intervention arm

EXPERIMENTAL

Subjects is randomized to start with either a period of reference product use followed by a cross over to using the study device or the opposite sequence, starting with the study device and then cross over to using the reference device.

Device: THD, THN

Interventions

THD, THN DEVICE

New hybrid absorbing incontinence product for day (THD) and night (THN) use. These are variants of the same product. The intervention product is a novel design that contains reusable elements allowing for a more sustainable product.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have urinary incontinence managed with size M or L (96 -116 cm hip range) TENA Slip and/or TENA Comfort with absorption level plus, super or maxi.
• Be willing and able to provide informed consent and to participate in the clinical investigation.
• Be a permanent (intended length of stay longer than 3 months) resident of the care home.
• Have a stable dose regime if the incontinence is managed by pharmaceuticals.
• Be over 18 years of age.
• Not be of child-bearing potential.

You may not qualify if:

• Being cared for at home or outside of professional care environment.
• Goes to the toilet to urinate regularly.
• Have severe incontinence product related skin problems, as judged by the investigator.
• Have any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
• Suffering from fecal incontinence with a severity that makes participation in the clinical investigation inappropriate, as judged by investigator.
• Suffer from severe dementia that makes participation in the clinical investigation inappropriate, as judged by investigator.
• Having any other condition or recent surgery that may make participation in the clinical investigation inappropriate, as judged by investigator.
• Frequently removes the incontinence product by themselves.
• Have participated in an investigational study of a drug, biologic, or medical device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
• Having an alcohol or drug addiction.

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead
• Lincolnshire Community Health Services NHS Trust: collaborator

Study Sites (1)

Lincolnshire Community Health Services NHS Trust

Lincoln, LN5 7JH, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janice Weisman

  Lincolnshire Community Health Services NHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As the study device is obviously different to the currently used device, and all subjects will use the same treatment.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group cross over. Study subjects are randomized to sequence of device use. To either start with reference of study device.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 19, 2023
• Study Start: November 6, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)